How CROs and Sponsors Improve TMF Management with a Shared eTMF - Agatha eTMF software

Agathalife EN
18 Feb 202259:29

Summary

TLDRIn this insightful webinar, industry experts Barb, Ken, and Carrie delve into the evolving role of Technology in Clinical Operations (TiCO) and its impact on Trial Master File (TMF) management. They discuss the critical relationship between stakeholders, the technological advancements in eTMF systems, and the importance of collaboration and transparency. The webinar also explores the challenges and future trends in TMF management, emphasizing the need for a more integrated and automated approach to enhance efficiency and regulatory compliance in clinical trials.

Takeaways

  • 🤝 Strong collaboration and mutual respect between sponsors and CROs are crucial for successful clinical trials.
  • 📋 Clear expectations and roles from the outset can significantly improve the efficiency of trial management.
  • 💻 Embracing technology like electronic Trial Master Files (eTMFs) can streamline processes and enhance communication among stakeholders.
  • 🔍 Transparency in the TMF is essential, with regulators like the FDA expecting the TMF to tell the full story of a clinical trial.
  • 🌐 The TMF should not be seen as merely a storage space but as a dynamic tool for collaboration and process management.
  • 🔗 The future of TMFs involves integration with other systems and platforms for seamless data exchange and remote monitoring capabilities.
  • 📈 Regular audits and quality checks of the TMF by all parties ensure regulatory compliance and maintain trial integrity.
  • 🛠️ Challenges in past collaborations can provide valuable lessons for improving future partnerships and working relationships.
  • 📊 Adopting a digitized approach for clinical trials can significantly improve data management and regulatory compliance.
  • 🎯 Tailoring the TMF to the specific needs of a study and its stakeholders can enhance its utility and effectiveness.

Q & A

  • What is the main focus of the webinar?

    -The main focus of the webinar is to discuss how CROs and sponsors can improve TMF (Trial Master File) management through collaboration and the use of technology.

  • What role does technology play in the management of TMF?

    -Technology plays a crucial role in TMF management by automating processes, enabling collaboration between stakeholders, and providing a platform for storing, tracking, and sharing essential documents throughout the clinical trial process.

  • What are some key aspects of a successful relationship between sponsors and CROs?

    -Key aspects of a successful relationship between sponsors and CROs include clear expectations, mutual respect, open communication, collaboration, and a shared purpose or goal.

  • How does a CRO like DZS approach selecting a TMF for their clients?

    -DZS approaches selecting a TMF by looking for systems that are robust, intuitive, dynamic, and cost-effective, and that can meet the specific needs of their clients, who are often smaller to mid-sized companies.

  • What is the importance of having a well-managed TMF?

    -A well-managed TMF is essential for ensuring regulatory compliance, facilitating efficient communication and collaboration between trial stakeholders, and ultimately, for the successful execution and completion of clinical trials.

  • How does the use of an electronic TMF (eTMF) benefit the clinical trial process?

    -The use of an eTMF benefits the clinical trial process by streamlining documentation management, enabling real-time access and updates, improving version control, and providing a centralized platform for all trial-related information.

  • What are some challenges that can arise in the relationship between sponsors and CROs?

    -Challenges in the relationship between sponsors and CROs can include a lack of trust, poor communication, adversarial dynamics, and an overemphasis on minor details at the expense of the bigger picture.

  • How does the webinar address the topic of technology adoption in clinical operations?

    -The webinar addresses technology adoption in clinical operations by discussing the different stages of adoption, from basic tools to fully digitized processes, and by exploring how organizations can leverage technology to improve TMF management and collaboration.

  • What is the significance of the 'observer effect' in the context of sponsor-CRO relationships?

    -The 'observer effect' in the context of sponsor-CRO relationships refers to the idea that when one party is closely monitoring the other's every move, it can affect the natural flow of work and lead to increased stress and reduced efficiency. Trust and allowing for autonomy are key to avoiding this effect.

  • What is the role of the TMF in regulatory audits?

    -The TMF plays a critical role in regulatory audits as it contains all the essential documents and information about the clinical trial. Regulators may request access to the eTMF to conduct their audit, expecting the documents to collectively tell the story of the trial and stand on their own.

Outlines

00:00

🎤 Introductions and Housekeeping

The webinar begins with Barb, the host, welcoming participants on behalf of Agatha and DCS Clinical Services. She introduces the topic of the day - how CROs and sponsors can improve TMF management with a shared TMF. Barb explains her role in housekeeping and assisting with any issues, and emphasizes that the session is being recorded for later access. She also mentions the availability of slides and the importance of filling out the post-webinar survey.

05:00

🤝 Building Relationships and Trust

Carrie Brown, Senior Director of Clinical Services at DZS, shares insights on managing the TMF from a clinical operations perspective. The discussion focuses on the importance of clear expectations, mutual respect, and open communication in building successful relationships between sponsors, CROs, and sites. The conversation highlights the benefits of having a collaborative environment where all parties work towards the same goal, emphasizing the role of trust in overcoming challenges.

10:01

📈 Understanding the Technology Landscape

Ken and Carrie delve into the technological aspects of TMF management, discussing the various points of interaction and collaboration between sponsors and CROs. They explore the role of technology in enabling effective communication, task management, and regulatory compliance. The conversation touches on the evolution of TMF systems from simple document storage to sophisticated, interconnected platforms that facilitate real-time collaboration and oversight.

15:02

🔍 Navigating TMF Ownership and Management

The panelists discuss the practicalities of TMF ownership and management, considering scenarios where sponsors have their own systems or delegate TMF management to CROs. They emphasize the need for sponsors to remain involved in the TMF process to ensure accountability and familiarity with the trial's documentation. The discussion also highlights the importance of the TMF in telling the story of the clinical trial and the increasing expectations from regulatory bodies like the FDA.

20:04

📊 Exploring the Future of TMF and ETMF

Ken presents a vision for the future of TMF and ETMF, suggesting that these systems should move beyond being mere repositories of documents to becoming dynamic, interactive platforms that facilitate all aspects of clinical trial management. He outlines the features of a fourth-generation ETMF, including remote monitoring, collaborative authoring, and dashboards for visibility and collaboration. The conversation touches on the potential for fully digitized trials and the move towards a more connected, efficient, and transparent clinical trial process.

25:04

🤝 Establishing Successful Partnerships

In the final segment, Carrie offers advice to newcomers in the clinical research field, emphasizing the importance of establishing rapport and building trust from the outset of a relationship with sponsors or CROs. She discusses the value of clear communication, mutual respect, and the willingness to collaborate and adapt to each other's needs. The conversation concludes with a reflection on the similarities between implementing new technology and launching a new clinical trial, highlighting the importance of investing in strong relationships from the start.

30:06

📚 Additional Resources and Closing Remarks

Barb and Ken wrap up the webinar by informing the audience about available resources, including a white paper co-authored by the panelists and a forthcoming webinar on the technology adoption curve. Ken extends an invitation to participate in a research project aimed at understanding and improving technology adoption in clinical trials. The session concludes with thanks and appreciation for the audience's participation and engagement.

Mindmap

Keywords

💡Clinical Trials

Clinical trials are research studies performed with human participants, aimed at evaluating the efficacy and safety of new medical interventions or treatments. In the video, the speakers discuss the collaboration between sponsors and CROs (Contract Research Organizations) in managing clinical trials and the role of technology in improving the process.

💡Sponsors

Sponsors in the context of clinical trials are typically the pharmaceutical companies, biotech firms, or other entities responsible for the initiation, management, and financing of the trial. They are crucial in deciding the direction of the trial and ensuring compliance with regulatory standards.

💡CROs (Contract Research Organizations)

CROs are organizations that provide support to the sponsors in the form of specialized services for the management of clinical trials. They can handle various aspects of the trial process, from site selection to data collection and analysis.

💡TMF (Trial Master File)

The Trial Master File is a comprehensive set of documents that provide a complete history of a clinical trial. It includes protocols, informed consent forms, regulatory submissions, and other essential documents that are critical for the regulatory compliance and oversight of the trial.

💡Technology

In the context of the video, technology refers to the use of digital tools and systems to streamline and enhance the management of clinical trials, including the TMF. This can include electronic document management systems, communication platforms, and other software solutions that facilitate collaboration and data management.

💡Collaboration

Collaboration in this context refers to the cooperative effort between different stakeholders in a clinical trial, such as sponsors, CROs, and clinical sites, to achieve common goals. Effective collaboration is essential for the successful management of clinical trials and can be facilitated by clear communication, mutual respect, and shared systems like the TMF.

💡Regulatory Compliance

Regulatory compliance refers to the adherence to rules and regulations set forth by governing bodies, such as the FDA, to ensure the safety and efficacy of medical products and interventions. In clinical trials, this involves following specific guidelines for the conduct, documentation, and reporting of the trial.

💡Electronic Documents

Electronic documents are digital versions of paper-based information, which in the context of clinical trials, can include protocols, consent forms, and other critical trial documents. The use of electronic documents can improve efficiency, accessibility, and the ability to maintain version control.

💡Dashboards

Dashboards are visual displays of key performance indicators (KPIs) and other relevant data, providing an overview of the status and progress of a project or system. In clinical trials, dashboards can help stakeholders monitor the progress of the trial, identify issues, and make informed decisions.

💡Remote Monitoring

Remote monitoring refers to the oversight and management of clinical trials from a distance, using digital tools and technologies. This approach allows for real-time tracking of trial activities and data without the need for physical presence at the trial sites.

Highlights

The webinar discusses the improvement of TMF (Trial Master File) management through CRO (Contract Research Organization) and sponsor collaboration, emphasizing the role of technology in streamlining processes.

Barb, from Agatha, and Ken, from DCS, co-host the webinar, with Barb handling housekeeping and Ken presenting the main content.

Carrie Brown, Senior Director of Clinical Services at DZS, joins as a guest speaker to share insights on managing the TMF from a clinical operations perspective.

The webinar covers the importance of trust in sponsor-CRO relationships, highlighting how mutual respect and clear communication lead to better collaboration and overall project success.

Ken emphasizes the need for technology to connect people and automate processes, underlining the significance of a robust, intuitive, and cost-effective TMF system.

Carrie shares her experiences with successful sponsor-CRO relationships, where clear expectations and roles from the outset are critical for a productive partnership.

The discussion touches on the challenges faced in less-than-ideal sponsor-CRO relationships, where a lack of trust can lead to a defensive and detail-focused environment.

Ken introduces the concept of the 'observer effect' in project management, illustrating how close monitoring can impact team performance and the importance of trust.

Carrie outlines five key points for establishing good relationships: clear expectations, mutual respect, honest communication, ongoing lessons learned, and collaboration with a shared purpose.

The webinar explores the different areas where CROs and sponsors interact, including protocol development, study plans, case report forms, statistical output, and the TMF itself.

Carrie discusses the various ways sponsors and CROs can manage the TMF, either through the sponsor's system, the CRO's system, or a collaborative effort.

The conversation highlights the FDA's expectation for the TMF to tell the story of the clinical trial, with the agency sometimes conducting audits directly through the eTMF.

Ken presents a technology adoption curve for clinops, showing the progression from basic tools to fully digitized and interconnected systems.

Carrie agrees with Ken's vision of the eTMF as a central system for collaboration, dashboarding, and process management, rather than just a document repository.

Ken outlines the necessary features of a fourth-generation eTMF, including site connectivity, remote monitoring, collaborative authoring, review and approval workflows, and dashboards for visibility.

Carrie mentions a client that is close to achieving a fully digitized trial process, using an electronic TMF and investigator site files for remote monitoring.

Ken offers a free audit to organizations interested in understanding their position on the technology adoption curve and identifying the best next technology investments.

The webinar concludes with advice for new professionals in the field, emphasizing the importance of building rapport and establishing clear roles and trust from the beginning of a project.

Transcripts

play00:06

all right ken we lost your um special

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music play in there i think we were all

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gonna maybe have a nap with that stuff

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hi everyone um on behalf of agatha and

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dcs clinical services welcome to the

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webinar how cros and sponsors improve

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tmf management with a shared tmf i'm

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really excited to see everyone here

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today lovely to see so many people

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coming online my name is barb and i'm

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here to kick things off

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i don't do the presenting i just do the

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housekeeping and helping you if you have

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any issues

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so let's go through the housekeeping

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tidbits first so that we can get things

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moving um first of all we are recording

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so you will get a copy of the replay

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and if you weren't able to attend then

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you're getting a copy of the replay as

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well and we will share the slides out so

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you will get the slide deck as well

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if you have questions ask them

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throughout the presentation or

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throughout the talk between ken and

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kerry put them in the q a section if you

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can not the chat but i'll keep an eye on

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both just in case questions come into

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both and ken and kerry will take

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questions throughout the session and not

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kind of poke in and

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kind of talk to them when i think that

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you've got something that really works

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well for them

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and

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other than that there is a survey at the

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end of the webinar that i would really

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appreciate if you all took the time to

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fill out

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so with all of that out of the way i'm

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going to turn it over to ken and kerry

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take it away ken

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thanks barb

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i'm definitely insulted that was

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carefully chosen music but apparently

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not invigorating guns and roses next

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time i warned you about that

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hi everybody hey thank you for joining

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it's really nice to have you

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i'm so excited about this topic i i am

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anyway and then i found it really

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resonated

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with an audience there's more than 80 of

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you who have connected

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and we're um

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we're just going to dive into this topic

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of cro and sponsor collaboration extend

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it to the sites as well talk about the

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role of technology

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it's fascinating for me i consider

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myself a technologist

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so i look at problems as how can we put

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in place the technology to connect

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people to

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automate processes so that's where my

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brain lives

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and then there's the people side uh well

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these are companies cross our companies

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sponsors sites and they're people and

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making it all work is really interesting

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and i've been fascinated by this

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especially cros and sponsors around the

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tmf even down to the fundamental issues

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of who gets to choose the dmf is it the

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sponsor or the cro and who pays for it

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and how does that work so all these

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topics are very interesting to me

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and i'm really lucky to have carrie

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brown joining me uh carrie's the senior

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director of clinical services or

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clinical operations at dzs

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i've been working with dzs for a couple

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of years now they actually are an agatha

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client

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but they have of course many of their

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own clients um sponsors and they work

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across sites

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and she as the head of the team

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really deals with the sponsor cro

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and site nexus

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and making that work

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she also brings a background that goes

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beyond dcs and that's always interesting

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she's worked with some bigger farmer as

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well as you'll see

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at baxter and kendall we're connected

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from a few geographies i'm up in new

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hampshire

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barb is in canada and carrie's connected

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from snowy colorado today

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our approach today is more uh well it's

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not more it's a balance between a

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presentation and almost a webcast style

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so you'll see fewer slides

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a little more talk hopefully a nice

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bounce for you i make only one promise i

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can't promise you'll learn something i

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just can't promise these things i can

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promise

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this should be the most relaxing part of

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your week so sit back relax and we'll

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chat for 50 minutes or so i do want you

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to take a poll first this is one of two

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if barb will put it up we just want to

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know who's out there are we speaking to

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mostly cross sponsors sites site people

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or other so a real simple one would you

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describe your organization as

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the first choice a sponsor of clinical

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trials typically a drug or device

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manufacturer or biotech

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number two a cro or other specialty

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service provider someone who serves the

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industry by managing clinical operations

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and clinical trials third a clinical

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site or you represent a collection of

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sites a site management organization for

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instance or other

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you're just visiting that's fine too so

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really interested in that we'll give it

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a second i think barb you can tell us

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when you have a

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plurality of the right number of people

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to show the result

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yeah we'll just give it a couple more

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seconds

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well we have just a quick pause i'll

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just say hi and i'm thankful that i have

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the opportunity to do this together with

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ken and agatha and

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um and i'm happy to be here and excited

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to

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relay information and sort of um our

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thoughts as well from a clinical

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operations perspective on how we manage

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the tmf and um you know hope that we hit

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on some topics that you're interested in

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but certainly ask questions um so that

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you know we're

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you're walking away with some some

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information and an answer to a question

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that you have so

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um glad to be here perfect

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so the results are here you can see the

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percentages and it's ideal we have

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a split between sponsors and service

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organizations almost evenly uh some site

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people mixed in and then others we won't

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worry about the others as i said

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um so we can have a few perspectives and

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that's just perfect

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i also sent out if you can click can i

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close that bar with you

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we also sent out uh or i sent out a

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personal request for some input from the

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audience on this topic and whether to

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cover more

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the relationship aspects in general or

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the technology around the tmf in

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specific and i got back of course a mix

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of answers and the result is we're going

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to cover both we're going to start at a

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high level and then drill into the tmf

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so carrie um well first to the audience

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you're going to see these topic slides

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and think of these as the chat areas and

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there'll be a few slides mixed in for

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this first chat

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area i know you just started your

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introduction but can you just tell us

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all a little bit about dcs so we know

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where you're coming from uh do you deal

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mostly with smaller or bigger companies

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what kind of trials just anything you

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can give us for content

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fair sure

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um so dzs

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we consider ourselves a mid-sized cro

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um

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we tend to work with smaller to mid-size

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device and drug companies so not

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necessarily we have worked with some of

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the bigger named well-known names

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companies but we tend to kind of focus

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on the small and mid-sized companies

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we do provide a full spectrum of

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services so all the way from early

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clinical development um consulting and

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and input and analysis all the way

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through clinical operations um data

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analytics including data management and

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stats uh medical affairs and

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pharmacovigilance

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i would consider dc as a very technology

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driven company we work to really find a

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good fit for our clients and their needs

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and we look for systems that are very

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robust that are intuitive

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dynamic and cost effective

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you know which is exactly why i guess

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we've worked and landed on agathon when

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we have input with a client as to which

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tmf to use it's one that we recommend

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because it does cover all those bases

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and is a very nice cost-effective

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solution for our clients that that don't

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always have um large um bulks of funding

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and so forth so it works great and then

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just um quickly i guess we pride

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ourselves on just providing really great

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customer service and communication and

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we work best and really like to partner

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with our clients so that's emphasis on

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partnering so

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we really like to kind of be an

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extension of their team

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well thank you very much for that um

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that's a perspective i wanted everyone

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to have i as a

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one of the leaders in a technology

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company bring as i said a certain

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perspective we also tend to work with

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smaller organizations less with the

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largest pharma

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a lot of younger companies who are

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building out infrastructure

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and we're a part of that there's one

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last thing i wanted to do which was to

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say hi to a few people and then we'll

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really jump in because i scanned the

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list and

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i think bob marley said a few good

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friends along the way that i've met so

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nice to see some of you here i think

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i've met rodrigo anki if that's how i

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say your name we've just had an

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extensive email conversation so thanks

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uh victoria um working together all the

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time so nice to see you in there uh two

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more uh sama um well known to carrie as

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well as me and then lastly um julie burt

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and audrey

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just new friends you might say that i've

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made along the way so thank you guys all

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for joining and i do hope i deliver on

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it will be the

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it's not good english but the funnest

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part of your week or at least the most

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relaxing maybe not fun about relaxing if

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there's no alcohol i don't think it's

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fun no that's not

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um so i want to jump in topic number one

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of four the critical relationship

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between the stakeholders and i wanted to

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get carrie into the mix right away and

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set the stage this way

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we're going to talk about these

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relationships and i'm asking carrie to

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envision in her mind

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a particular sponsor that she's worked

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with around some trials and i want her

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to just

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uh romance that for us tell us how

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wonderful it was and what made it

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wonderful so i want to hear about the

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best

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project you've ever worked on with a

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sponsor as a cro

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sure sure

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um so yeah i can think of a couple

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clients thankfully that we've had the

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opportunity to work with that have just

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been really great working relationships

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were

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considered an extension of their team

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they they almost don't differentiate us

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from their own company

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and they really

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bring a lot of respect and um

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to us and our opinion and the expertise

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that we bring

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there's just a mutual

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trust

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knowing that we will provide them with

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clear up front communication and

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expectations um

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and it's just you know a great

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collaborative effort where they really

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appreciate what we have to say and what

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we do

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um and it just provides for a great

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working environment everyone's really

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working their hardest to

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to

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do their best for the client so

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trust is such an interesting and

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important part of it all of course as a

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technology provider we have customers

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and we implement software solutions for

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them and trust just looms very large

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because if you start with trust

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then even if something goes a little

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awry you can work it out easily if you

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start with uh less trust

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it can get difficult right away and with

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that as the intro to what i'm going to

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ask you now it's kind of rude of me

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because we'd like everyone listening to

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say every dcs relationship is perfect

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every sponsor is perfect it's a love

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fest so let's talk about before you were

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at dcs maybe some project that you

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remember

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that was more of a horror show where it

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just was a really difficult environment

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can you tell us a little bit about that

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and why you think it was that way

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sure um yeah i mean unfortunately i've

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been in that position it's not as much

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fun it doesn't make for as much fun at

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work

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um but it was more uh sort of

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adversarial i'd say um where they kind

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of made it clear that they were the the

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client they were the sponsor you were

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the service provider you know it was a

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separate entity you were there to

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provide to them um specific services

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um and it just kind of had a tendency to

play12:20

put you on the defensive um i think it

play12:23

kind of led to um

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you know really

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laboring over every word that you wrote

play12:29

or uttered to make sure it wasn't

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misinterpreted or twisted in a different

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way so just made it a very challenging

play12:34

environment where a lot of energy was um

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used and focused on the minutia and i

play12:41

think that in kind of stepping back from

play12:43

that since that time

play12:45

looking sort of lessons learned i think

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that it didn't allow the team to really

play12:49

look at the big picture and i think you

play12:51

kind of really lose

play12:52

um

play12:53

lose something when you're so

play12:56

focused on the details and making sure

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you don't make any single small misstep

play13:00

that you kind of lose the big picture of

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the of of the of what you're doing in

play13:04

the service you're providing so can make

play13:07

it more challenging for sure and more

play13:08

stressful

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really interesting to me the uh the idea

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that you know you have energy a certain

play13:15

amount of energy

play13:16

on the team and it can go into solving

play13:19

the problems for the patients for the

play13:21

trial driving exclusion or you can use

play13:23

up a lot of that energy internally

play13:25

in any company we know that i call it

play13:27

internal stupidity when people are just

play13:29

acting stupidly

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excuse my language internally rather

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than focusing on what we need to do

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which is deliver for the customers and

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that's true the sponsor and the cro um i

play13:40

was also thinking and i know i mentioned

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this to you carrie earlier i actually

play13:43

did the research afterwards this whole

play13:45

observer effect thing for those of you

play13:47

who are physicists you know more than i

play13:49

do about quantum mechanics and quantum

play13:51

physics and schrodinger's i can't say

play13:54

his name cat and all that but if we

play13:56

observe things too closely we affect

play13:59

them

play14:00

and so when people drill down and

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they're watching every step of what they

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do

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things don't go the way they should i'm

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just thinking of a simple thing like uh

play14:09

having i

play14:10

have a

play14:11

an antique car that's being restored and

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if i go and watch them do it i'm sure

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the mechanic makes mistakes he wouldn't

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make if i wasn't watching you know

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nobody wants to be watched that closely

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so it goes back to trust again which is

play14:23

interesting

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so with those two examples excuse me i

play14:27

went an extra page carrie can you just

play14:29

run through these five things that i

play14:31

think you

play14:32

summarized as these are what you really

play14:35

need to focus on to have a good

play14:37

relationship from the outset

play14:39

sure sure

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so i think just having clear

play14:41

expectations set really early on through

play14:44

um you know that can be through detailed

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roles and responsibilities it can kind

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of be set in other ways as well

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um but i think that that's really

play14:51

important so everyone comes to the table

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knowing sort of who's doing what and

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um and and how you know how things are

play14:59

to proceed so i think that's really

play15:01

important and for those of you that are

play15:03

on the cro side that are more of a

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service provider you know i do feel like

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it is sort of our

play15:08

role to drive that process and to

play15:11

really you know review carefully the

play15:13

statement of work um

play15:15

through the kickoff meeting and kind of

play15:18

relay that in that meeting with the

play15:19

client and just make sure that it's

play15:21

talked through and everyone is very

play15:23

clear on those roles and

play15:24

responsibilities um the next thing as

play15:27

i've mentioned i guess um in sort of a

play15:29

good relationship that we've had before

play15:31

or i've had with a working with a client

play15:33

is just that mutual respect for the

play15:36

expertise that each party brings to the

play15:38

relationship so obviously understanding

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you know again i've got sort of my sero

play15:42

uh lenses on so through my cro lenses

play15:45

it's sort of you know obviously

play15:47

respecting the fact that the client

play15:48

knows their device they know their drug

play15:50

in depth and you can really gain a lot

play15:52

from

play15:53

tapping into that so that you can really

play15:56

understand their product and and and

play15:58

their history with that product and can

play16:01

use that to to just better your services

play16:03

and what you do and how you do it

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and then also hopefully from the other

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side that they can really um the clients

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can really respect that as a cro or a

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service provider you really bring a lot

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of knowledge about that clinical

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operations aspect of things um and have

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done

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operations numerous times across

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different studies and therapeutic areas

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and so forth and can really

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appreciate what you bring

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from that perspective

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um

play16:32

the next one honest and open

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communication again i think that's so

play16:35

critical

play16:36

um you know sort of things come up right

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no one's perfect and so uh things come

play16:41

up and we all

play16:43

make mistakes unfortunately we're human

play16:45

and so it happens it's our human nature

play16:48

um so i think you know especially for

play16:49

that just being able to have honest and

play16:51

open communication with timelines if

play16:53

they're slipping and so forth having

play16:54

that really being able to have that

play16:56

really honest open communication um

play16:58

coming to the table i think as a cro or

play17:00

service provider it's important to come

play17:02

to the table with solutions or

play17:06

corrective or preventive actions that

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you're already

play17:08

establishing for anything that might not

play17:11

be going just as planned

play17:13

so i think that that's really important

play17:14

i think kind of doing ongoing lessons

play17:16

learned throughout a trial as things

play17:18

come up and you realize you know maybe

play17:20

it wasn't a complete mistake but maybe

play17:21

it was something that could have gone a

play17:23

little bit better than it did and having

play17:24

those ongoing communications

play17:26

and collaboration i think is very

play17:28

important um

play17:30

right we hear so much about just having

play17:32

visibility into things um

play17:34

is such a buzz word these days and so i

play17:36

think really uh

play17:38

communication can kind of help to aid

play17:39

that so they really feel comfortable

play17:41

that you're gonna bring things forward

play17:42

and they're not gonna suddenly find out

play17:44

um late on later on that something

play17:46

happened that you were trying to hide

play17:50

um

play17:51

collaboration i think is important you

play17:54

know and that kind of all these

play17:55

different things kind of cover that

play17:56

really from start to finish you know

play17:58

that it is a collaborative effort even

play18:00

if they've really assigned a lot of the

play18:01

responsibility to a cro it is important

play18:03

to collaborate and you do need uh the

play18:05

client input as well on on numerous

play18:08

things and then just working with the

play18:10

shared purpose like what is the goal

play18:11

what are we all working for let's um you

play18:13

know work toward the same purpose

play18:17

well thanks it's a

play18:20

interesting list and of course the thing

play18:22

jumping out at me is collaboration

play18:24

because once again from a technology

play18:26

perspective i'm focused on how do we

play18:29

enable that collaboration we can't force

play18:31

it but we can make it easier and i think

play18:34

it happens not just in the etmf

play18:36

but other systems so i had asked harry

play18:38

to put together a list

play18:41

excuse me

play18:42

still having some trouble with my order

play18:44

here

play18:46

we'll be there in a second

play18:48

um this list it's a delay on my side so

play18:50

i keep hitting the button too many times

play18:53

a list of technology areas where cross

play18:56

and sponsors do interact i shouldn't

play18:58

just said technology carry just areas

play19:00

where they interact so this was your

play19:02

list of these are major points of

play19:04

interaction and collaboration is that

play19:06

right

play19:08

yeah right where um you know it can't

play19:10

just be driven by one side or the other

play19:12

i mean um you know even for instance the

play19:14

first one with protocol development even

play19:16

if the sponsor is really doing the

play19:17

writing the protocol and that's not a

play19:19

service that they've um

play19:22

asked the cro to to participate in i

play19:24

think we always welcome the opportunity

play19:27

to review the protocol before it's

play19:28

completely final and provide some input

play19:30

as far as our our um

play19:33

uh perspective on operations and so

play19:35

forth so but either way um you know i

play19:38

think both both sponsor and cro can

play19:40

bring some really that a lot of value to

play19:43

developing the protocol uh and making

play19:45

sure it's a good solid protocol that's

play19:47

realistic and the sites can follow and

play19:49

so forth um and then study plans and

play19:51

these are just so important um

play19:53

[Music]

play19:55

just

play19:56

uh to make sure that everyone again is

play19:58

sort of on that same page and making

play19:59

sure everyone's clear on roles and

play20:01

responsibilities and exactly how

play20:03

we're gonna carry out the different

play20:05

functions that have been delegated to us

play20:07

so as a cro so i think those study plans

play20:09

are very important to make sure that

play20:11

everyone's in agreement with the way

play20:12

that the

play20:13

study is going to run

play20:15

that can be your project management plan

play20:16

your tms plan a data management plan

play20:19

there are lots of different plans that

play20:20

go into

play20:23

kind of laying out the expectations and

play20:24

how the study is going to progress

play20:26

and then case report forms obviously

play20:29

we want to make sure we're collecting

play20:31

the data that's going to be needed by

play20:32

the cro so this is very important to

play20:34

have some collaboration on

play20:37

and the statistical output is incredibly

play20:40

important just

play20:41

both how we're going to do the analysis

play20:43

as well as what the ultimate

play20:45

tables listings and figures are going to

play20:47

look like which

play20:48

dzs i guess we present those through

play20:51

mock shells so that the client can kind

play20:53

of see exactly what the output's going

play20:54

to look like and what information we're

play20:56

planning to display in those final

play20:58

outputs

play20:59

and then of course the tmf

play21:02

which is you know the

play21:04

tells the story of the uh clinical trial

play21:06

and then so that needs to be a very

play21:08

collaborative effort as well

play21:11

i find the list interesting because some

play21:13

places i know the system that's used

play21:15

study plans might be a ctms for instance

play21:18

uh statistical output might be

play21:20

at least part of it related to an edc

play21:22

system

play21:24

i see collaboration tools for protocol

play21:26

development and

play21:28

for board reporting the tmf is

play21:31

interesting to me because one of my big

play21:32

theses is

play21:34

it tends to be thought of as a place to

play21:36

put stuff

play21:37

and my argument is that's very

play21:39

old-fashioned thinking it's not a place

play21:41

to put stuff it's a place to do stuff

play21:44

and that's really the focus as we go so

play21:47

it's a

play21:48

good transition into topic number two

play21:51

so who's tmf is it anyway

play21:54

um

play21:55

this is one of the things i previewed

play21:58

excuse me early on in our discussion

play22:00

today

play22:02

but there's something i know because

play22:04

i've read it

play22:05

legally the tmf is the responsibility to

play22:07

sponsor it is their

play22:10

responsibility regulatory if i can say

play22:12

um to make sure there is a complete tmf

play22:14

et cetera et cetera

play22:16

but of course many times it's delegated

play22:19

to the cro

play22:20

so help me out carrie what's more

play22:22

typical

play22:24

is it often owned by both or managed by

play22:27

both i'm using the term own probably

play22:29

incorrectly but

play22:30

tell me in real life how you work with

play22:32

sponsors around a tmf

play22:35

sure

play22:36

i mean i've kind of worked in a couple

play22:38

different ways i mean sometimes the

play22:39

sponsor has their own the client has

play22:41

their own tmf system that they would

play22:43

like you to use um and they might you

play22:46

know control access rights and so forth

play22:48

in the setup of the tmf through their

play22:50

i.t department or another functional

play22:52

area within their team or they might you

play22:54

know want you to provide and house the

play22:56

tmf

play22:58

set it up provide access rights and

play23:00

remove access rights etc so kind of can

play23:02

go either way

play23:04

um as far as that goes but then um

play23:08

then it does need to be a collaborative

play23:10

effort and generally we've worked with

play23:12

some clients where they pretty much

play23:13

delegate the rest of the tmf management

play23:16

uploading documents into the system cue

play23:18

seeing them doing an overall qc of the

play23:20

tmf

play23:22

to the cro

play23:24

but i would argue that there needs to be

play23:26

some role of the sponsor or the client

play23:28

in the tmf even still

play23:30

and we have had clients that have

play23:33

you know we do the document loading we

play23:35

qc the documents but they do some of the

play23:37

overall qc of the tmf and that's a great

play23:39

way to do it i mean i would argue that

play23:42

the client really needs to know their

play23:45

tmf um at the end of the day like you

play23:47

said legally they're the ones ultimately

play23:49

responsible for it and accountable to it

play23:52

and they may have to answer questions

play23:53

about it right so they really need to

play23:55

know the tmf and be familiar with it so

play23:57

i think involving them in the process

play23:59

perhaps just through a very um

play24:02

infrequent qc and as the cro or the

play24:04

client you can do a more frequent qc um

play24:07

but having them participate or be

play24:09

involved in that in some way i think is

play24:11

really helpful

play24:12

um as you mentioned i guess and i agree

play24:15

that it's ken not just a place for

play24:17

documents to reside

play24:19

um

play24:20

but more and more the tmf as we're

play24:22

hearing from fda

play24:24

they expect the tmf to tell the story of

play24:26

the clinical trial um and i'm hearing

play24:29

more and more that in some instances the

play24:31

fda is just asking for access to the

play24:33

etmf

play24:34

um to do their audit and then they're

play24:36

auditing the tmf and they're not even

play24:38

sometimes speaking to

play24:40

um

play24:41

the sponsor or the the cro that may have

play24:43

been involved in that they really expect

play24:46

the documents to stand um for themselves

play24:48

and collectively to tell the story of

play24:50

this of the of the trial and so i think

play24:52

it's it's even more important than it

play24:54

used to be for the sponsor to be

play24:56

familiar with it

play24:57

um and understand that story

play25:01

we're going to be picking up on that

play25:02

thread but you just expanded the

play25:04

stakeholder group in a very interesting

play25:06

way

play25:07

of course

play25:08

systems like agatha's allow an auditor

play25:11

to

play25:12

have a selected view of the contents of

play25:14

the tmf for audit reasons so of course

play25:17

we're aware of that but when i think

play25:18

about collaboration i think about

play25:20

collaboration between cro sponsor and

play25:22

sites but it's also the regulator as

play25:24

you're saying the system is at the

play25:26

center of a lot of conversations and

play25:29

activities and processes

play25:31

so that's almost the whole story for

play25:33

today and we'll keep coming back to it i

play25:35

want to take a quick moment and do a

play25:37

second poll it is the second of two and

play25:40

it's again just to get a sense of who

play25:42

we're talking to so we can dial in our

play25:45

conversations um so barbara if you can

play25:48

throw up this poll it's about your

play25:50

current approach to trial master file

play25:52

content and it's in your

play25:54

organization do you use paper

play25:56

spreadsheets and shared folders or you

play25:58

know people say it's paper-based but i

play26:00

think they mean number one

play26:02

number two is it uh something like inbox

play26:05

dropbox a shared folder a shared drive

play26:08

it's a place where you put things

play26:10

uh sometimes those are called sync and

play26:12

share systems number three no it's an

play26:14

etmpf an electronic trial master file

play26:17

application or system of some sort

play26:20

or number four

play26:22

not applicable not what we do or you do

play26:24

it a different way that i haven't

play26:25

thought of which is certainly possible

play26:27

so if we can take a minute and ask you

play26:29

folks to do this poll

play26:31

uh we'll watch the answers and barb will

play26:33

let us know when we have

play26:35

a quorum

play26:36

and then we're going to go deep diving

play26:38

on etms topics

play26:40

for the next 20 minutes or so

play26:44

it says i cannot vote

play26:46

host and panelists cannot vote okay

play26:50

i think that's restricting my voting

play26:52

rights but

play26:54

be careful of the politics i suppose

play26:58

we'll go down that avenue

play27:02

so what do you think barb you have

play27:03

enough to share some results with us

play27:06

yeah um

play27:08

one person said they couldn't vote so i

play27:09

don't know if anybody's having trouble

play27:11

being able to vote but um which is weird

play27:13

because you should be able to but

play27:15

there's where we we ended up

play27:18

okay so

play27:21

very interesting uh this will be

play27:23

interesting with carrie because we've

play27:25

talked about it before that a quarter of

play27:27

you do use sort of um

play27:30

paper spreadsheets shared folders etc

play27:34

50 do have an etf in place of some sort

play27:38

it's a small number of inbox dropbox or

play27:40

a similar system that's interesting

play27:42

because a fair amount of agatha

play27:43

customers do come to us in that

play27:45

situation we have folders they are

play27:48

structured to reflect the etmf but

play27:51

they're not controlled so we have

play27:52

duplicates and other problems and then

play27:54

other or not applicable so that's who's

play27:57

out there carrie as we talk through the

play27:59

rest of this

play28:01

and as i said we do our deep drop dive

play28:05

on

play28:06

etm conversations

play28:09

so what i want to talk about is

play28:12

excuse me

play28:13

drop page

play28:17

that

play28:18

we want to think about

play28:20

technology in clinox

play28:23

in a certain way for the rest of our

play28:25

time together so i'm going to share a

play28:27

picture

play28:29

describe it and then we're going to come

play28:30

back to it at the end so be patient with

play28:33

me for a second

play28:34

but it's this picture i call it the

play28:36

clinops

play28:38

technology adoption curve on the bottom

play28:40

left you'll see basic tools

play28:43

like spreadsheets

play28:46

shared folders etc so that's what i

play28:48

think of as a stage one adoption in

play28:50

clinops

play28:51

stage two core systems you start to have

play28:53

an etmf maybe a ctms an edc system again

play28:58

the alphabet soup of systems available

play29:01

for clinical operations um stage three

play29:04

yeah just not just those systems but

play29:06

things are starting to be automated and

play29:08

interactive between the stakeholders

play29:10

stage four yes we have a lot of systems

play29:13

and they're connected the processes are

play29:15

connected and stage five is sort of this

play29:18

nirvana stage fully digitized if you ask

play29:21

me do i know any companies that are at

play29:23

stage five my honest answer would be

play29:26

no very close but it's not nirvana it's

play29:29

fully digitized with lots of issues so

play29:31

no reason in heaven yet from what i can

play29:34

tell um so that's the

play29:36

the way i'm thinking as i said i'll come

play29:38

back to that

play29:39

in just a little while

play29:41

what i want to do to to get there

play29:43

is share a couple of slides this is what

play29:46

i was saying carrie about

play29:48

thinking of the trial master as simply a

play29:50

central filing cabinet this is how it

play29:52

all started it's a place to put things

play29:56

and the documents are

play29:57

meant to tell the story of the study as

play29:59

you said

play30:01

over the years we've gotten a standard

play30:02

reference model so all of our tmfs are

play30:05

relatively similar

play30:07

although of course they have to be

play30:09

specific to your study

play30:11

and it may be

play30:13

managed by the sponsor managed by the

play30:15

cro

play30:16

or a collaborative space but it's still

play30:18

just a place to put things

play30:20

and my vision is i know this slide

play30:23

doesn't say much but i'm trying to

play30:24

capture the idea that the tmf is one

play30:28

critical system for interacting

play30:30

along with other systems that you named

play30:33

you know there has to be a dashboard for

play30:34

the study whether it's out of a ctms or

play30:37

a tmf but it's something that's telling

play30:40

every all the stakeholders here's where

play30:41

we are

play30:42

so dashboarding and metrics are are key

play30:45

to that interaction

play30:47

and lots of other systems as well so

play30:49

that's my

play30:50

hoped for vision another way to show it

play30:53

is this way with the trial master file

play30:55

at the center

play30:56

of a lot of processes

play30:59

yes for documentation but also

play31:01

for simple

play31:02

communication as i said dashboarding

play31:05

even just notifications tasks do et

play31:08

cetera collaboration

play31:10

where there might be work on a document

play31:13

that requires several people to be

play31:15

editing at the same time and the tmf has

play31:17

to support that while supporting the

play31:19

regulatory requirements that there's

play31:21

only one true copy eventually

play31:23

for monitoring activities so when we

play31:26

think of the tmf and we extend it to the

play31:28

site side for the investigate site

play31:30

files there's monitoring and there's

play31:33

quality processes for the tmf as you

play31:35

just mentioned

play31:36

so coordination process management the

play31:39

tf tmf becomes this engine rather than a

play31:42

place

play31:43

and that is as i said sort of my my

play31:46

central

play31:47

thesis

play31:48

of what we're trying to do here now when

play31:50

you look at this carry you see this

play31:52

picture

play31:53

is that like yes ken you're absolutely

play31:55

right or

play31:57

come on ken that's not really uh a valid

play32:01

picture of where we're going to get with

play32:02

the tmf i guess i want to say more

play32:04

simply am i overplaying the role of the

play32:06

tmf as this engine of collaboration or

play32:09

do you think it has a central role in

play32:11

keeping the stakeholders connected

play32:14

yeah no i completely agree i think it is

play32:17

um very central to to what we do it can

play32:20

be a very powerful tool for

play32:22

collaboration

play32:23

um you know within the agita system

play32:26

there's a way um you know i guess from

play32:27

my perspective against zero um you know

play32:30

as you're creating your plans and so

play32:32

forth there there are points in time

play32:33

where you're not quite ready to share

play32:35

those with the client you're not quite

play32:36

ready to to have their eyes on it um but

play32:38

once you kind of get to that point like

play32:40

a final draft if you will an internal

play32:43

final draft of a plan

play32:45

um the tmf is a great place to then uh

play32:48

upload that you can upload it as a draft

play32:50

into your system specifically and i'm

play32:52

sure others as well

play32:54

and then you can send that to review and

play32:56

so there's a great way to um collaborate

play32:58

within the system for the client to

play33:00

review those plans and provide their

play33:02

comments changes and feedback through

play33:04

that system so it's all kind of tracked

play33:06

with metadata and version control and

play33:09

and so forth and so that's it's a great

play33:11

way to collaborate um it gives them the

play33:14

tasks and the due date that you assigned

play33:16

to it so it kind of gives some

play33:17

accountability and so forth and just a

play33:19

way to um kind of keep that out of your

play33:22

inbox you know with things going back

play33:23

and forth and there's a lot of issues

play33:25

sometimes with version control

play33:27

and it's within a very a compliant

play33:29

system right so you don't um

play33:32

so you don't have to concern yourself

play33:34

with that and then certainly too i guess

play33:36

one of the other things that really

play33:37

jumps out at me is the monitoring

play33:39

perspective of things so when you add

play33:41

the uh electronic investigator site file

play33:44

to all of this that just really makes it

play33:47

all kind of come together right you can

play33:50

look at their

play33:51

essential documents within their site

play33:53

file as the cra and then just transition

play33:55

them if they're if you review and

play33:57

approve them you can just transition

play33:59

them right into the tmf um or you can

play34:02

give them comments and feedback if they

play34:04

need to adjust or modify something

play34:06

within that document and then it

play34:07

provides the opportunity for monitoring

play34:09

right because within the investigator

play34:11

site file there's a place for them to

play34:12

put documents such as source files and

play34:15

medical record files

play34:17

and even the informed consents that have

play34:19

protected health information that are

play34:20

very protected folders that only the

play34:23

monitor assigned to that site can view

play34:26

they cannot download they can't save um

play34:29

they can only view those for a limited

play34:31

period of time

play34:32

and then they no longer have access to

play34:34

those so

play34:35

it really just becomes yeah quite the

play34:38

the hub for

play34:40

a lot of what we do

play34:43

actually looked for a picture of a hub

play34:45

but i couldn't find the right kind of

play34:46

hubs i had hubcaps and other hubs but i

play34:49

didn't have the hub i wanted but it is

play34:50

kind of the vision that i have the hub

play34:52

at the middle of a gearing

play34:54

system i'm worried because you're

play34:56

encouraging me and i consider you a

play34:58

realist you know you're you're out there

play35:00

every day working on trials with

play35:02

sponsors and

play35:03

you're buying my vision here so as i

play35:06

said you're encouraging me which just

play35:08

means i'll go further

play35:10

and starting to think of the etmf as

play35:12

part of sort of a digital decentralized

play35:14

trial process if you take that curve i

play35:16

had up a minute ago it takes you right

play35:19

into

play35:20

the third phase of

play35:22

technology adoption which is fully

play35:25

connected

play35:26

processes

play35:28

workflows collaboration

play35:30

shared

play35:31

development of new items etc so that's

play35:34

kind of as we round the curve towards

play35:37

the last part of our session where i

play35:38

want to focus and

play35:40

talk a little bit about how to do that

play35:42

what does an etmf have to have in it the

play35:45

system to enable this kind of thing

play35:48

so

play35:49

you can tell i went backwards i

play35:50

apologize

play35:51

so now i get really crazy i'll try to

play35:53

describe this picture but carrie you

play35:55

were saying on the right hand side you

play35:57

have sites

play35:58

and sites need their own isf files they

play36:01

they don't want to be

play36:02

you don't want them in the tmf itself

play36:05

they need a self-contained space to

play36:07

upload their documents so even though

play36:09

it's in the cloud each of those isf

play36:12

icons belongs to a site

play36:15

and that's how it should be and how it

play36:17

i'll say needs to be it's maybe a tiny

play36:19

bit strong but it should be because

play36:21

they're responsible for those documents

play36:23

not not you they're they're documents

play36:25

they're the site

play36:26

but you want to monitor and oversight

play36:28

them so the cro on the left have lines

play36:31

going into

play36:32

those isf files where

play36:34

they can

play36:35

see documents that are ready for them to

play36:38

see

play36:39

and they can do oversight they can do

play36:41

monitoring they can do quality

play36:42

inspections just as they would if they

play36:44

were on site

play36:45

so that's starting to really enable a

play36:48

digitized model where everyone's

play36:50

connected through a shared

play36:53

system a shared architecture

play36:55

meanwhile the sponsor on the lower left

play36:57

has roles too

play36:59

notice the tracking and reporting

play37:01

because the tmf we want to keep track of

play37:02

what's still missing what percentage is

play37:04

done which sites are at what percentage

play37:07

complete

play37:08

and they may be involved in those

play37:10

workflows in the middle they're

play37:11

reviewing and approving

play37:13

because there may be protocol amendments

play37:15

that need to be reviewed and improved

play37:16

and the idea is to take it out of email

play37:19

take it out of excuse my language god

play37:21

forbid facsimile and get us to the point

play37:24

where

play37:26

these interactions

play37:28

are seamless they're automated and

play37:30

they're tracked

play37:31

and that's the key because we always

play37:33

need to keep track of what version

play37:35

who said what

play37:36

who signed off on it and that's what the

play37:39

etmf needs to do so as they say this

play37:42

isn't your father's etmf this isn't just

play37:44

a space to drag and drop things in a

play37:46

folder this is a system to manage

play37:49

relationships and interactions

play37:51

support the trusted environment so that

play37:54

there's less drop balls and there's less

play37:55

of those human errors that you were

play37:57

talking about carry in my view this goes

play37:59

a long way towards improved quality

play38:02

as well when we have a system that

play38:04

captures all the interactions probably

play38:06

shouldn't say all that's a technologist

play38:08

speaking there'll still be always other

play38:10

conversations etc but the majority of

play38:13

interactions

play38:16

so i wanted to cover a question that i

play38:17

was asked ahead of time when i said what

play38:19

should we cover and it's what should a

play38:21

etmf have in it and i decided to do it

play38:24

in two slides this is the basic

play38:27

agatha and virtually every other

play38:29

respectable vendor can do these basic

play38:32

things they can show your 21cfr part 11

play38:34

compliant they can tell you what's

play38:36

missing at any point that hasn't been

play38:38

added to the tmf and it's needed it's

play38:40

probably based on the tmf reference

play38:42

model it controls versions controls

play38:45

access allows you to collect electronic

play38:47

signature

play38:49

so all of those will call fundamental

play38:52

capabilities of any etmf but what about

play38:55

a fourth generation etmf that supports

play38:58

the kind of vision i was going through

play39:00

this is what i've added

play39:02

we're connecting the sites themselves

play39:05

each using their own isf workspace but

play39:08

all connected to a bigger picture we're

play39:10

using it for remote monitoring as carrie

play39:12

said there's collaborative authoring

play39:14

capabilities so that you can edit the

play39:16

same documents uh in place

play39:19

in the system

play39:20

and keep track of those edits comments

play39:22

so that we evolve to a complete version

play39:25

there's review and a work approval

play39:27

workflows task assignments for instance

play39:29

from a monitor down to the site correct

play39:32

this document

play39:33

and there's dashboards because the

play39:35

dashboards are critical for that

play39:36

collaboration so with these six things i

play39:39

think you get into the model of a fourth

play39:41

generation etmf that's much more than a

play39:44

place

play39:45

and it really is a system to track and

play39:47

manage processes

play39:49

does that all make sense to you carrie

play39:52

yeah no it makes

play39:54

perfect sense

play39:57

so i'm sorry to look at my notes um one

play40:00

last thing to chat about with uh with

play40:02

you specifically

play40:04

um

play40:06

this vision of a fully automated system

play40:10

uh is my vision and i have customers at

play40:13

agatho who have work i'll go back to the

play40:15

grandiose picture um who are very close

play40:17

to this now

play40:19

who agatha has a remote monitoring

play40:20

solution for the site side we have an

play40:22

etmf so we see people doing this

play40:26

carrie in your mind can you think of a

play40:29

highly technology a droid customer of

play40:31

yours that's approaching this kind of

play40:34

world are your customers or any of your

play40:36

customers getting towards this vision

play40:38

yet

play40:40

sure i can think of one in particular i

play40:43

guess doing a couple different studies

play40:45

with uh set up a little bit differently

play40:47

um

play40:48

there's one where they are you know

play40:50

really doing this they have the etmf um

play40:54

they're using the agatha tmf i think

play40:56

because we introduced them to it and

play40:57

they are

play40:58

um having their sites use the electronic

play41:00

investigator site file

play41:02

just which really you know

play41:04

aids in that remote monitoring aspect of

play41:07

things and

play41:08

um i don't know while you were talking

play41:10

ken it just popped into my mind my um i

play41:13

might be dating myself but going out and

play41:15

monitoring at the site reviewing their

play41:17

paper regulatory binder trying to

play41:21

reconcile all the correspondence

play41:24

um you know which is just plentiful and

play41:26

lots of emails and things just kind of

play41:28

difficult to name and track and keep

play41:30

track of and and how much easier it is

play41:32

with an electronic iff right i mean

play41:34

you're really looking at it and you're

play41:35

just moving it over to the tmf so you

play41:38

know that it's there um it's just it

play41:40

just makes you know that particular

play41:42

aspect of things a lot easier and and

play41:45

granted some of that correspondence

play41:46

isn't cree isn't critical documentation

play41:49

but some of it's important to the trial

play41:50

and and they are supposed to be a mere

play41:52

image of one another so you do need to

play41:54

do that um reconciliation so that just

play41:57

kind of popped into my mind but um

play42:00

with the same client i guess them

play42:02

they're actually i mean they're probably

play42:04

as close to nirvana

play42:06

stage five as you

play42:07

described though you know in my mind you

play42:10

know it's like giving someone five stars

play42:12

like can anyone ever really earn the

play42:13

five stars like can anyone ever really

play42:16

get to full

play42:17

digitization but

play42:18

um

play42:20

this particular client is doing a fully

play42:22

virtual trial with a with a virtual site

play42:25

um the patients are e-consented remotely

play42:28

they just do remote visits um they have

play42:32

a device and and tests that they do at

play42:34

home on a virtual call with the site um

play42:38

to make sure that they're performing

play42:39

things and using the equipment and so

play42:41

forth directly that data gets

play42:44

automatically recorded by the device and

play42:46

the different systems and into the cloud

play42:50

you know it gets transferred to us

play42:51

electronically to to analyze all that

play42:54

data for the ultimate statistical output

play42:56

and so forth so um and they're using an

play42:58

electronic tmf and that virtual site

play43:01

in this case has their own version of a

play43:03

electronic site file so um

play43:07

yeah it's it's it's really close to that

play43:09

full digitization like no one's actually

play43:12

it's very coveted safe we'll say

play43:14

no one's actually coming into contact

play43:16

with one another

play43:17

yeah and a lot of this moved very fast

play43:19

with kobe to push us all into this kind

play43:22

of a vision well that was nice because

play43:24

you kind of said yes ken there is a

play43:25

heaven so i kind of like it

play43:28

i do want to now do a jiu jitsu to

play43:31

everyone sorry if that's not the right

play43:32

term

play43:33

we started at high level conceptual

play43:35

relationships between the stakeholders

play43:38

we got into the technology talked about

play43:39

the etmf i want carrie to have the last

play43:42

word now and what i've put together is a

play43:44

hypothetical if you will

play43:46

carrie is a picture her uh

play43:49

in her evening

play43:51

outfits she's at a party and she's

play43:53

introduced to a

play43:55

little bit younger person who says i

play43:56

i've just gotten into this world i i'm

play43:59

not a a sponsor or a cro it doesn't

play44:02

matter and i'm about to start my first

play44:04

study and i'm nervous about the

play44:05

relationship i want to make sure we

play44:07

really do this right what's your advice

play44:09

to that person carrie what does she she

play44:11

or he most have to get right at the

play44:13

start of the relationship

play44:16

sure well i think i think you know just

play44:19

building good rapport like kind of

play44:21

setting up that report from the start is

play44:23

very important i think you can really do

play44:24

that um and at dcs as soon as we're

play44:27

awarded a study you know we do a kickoff

play44:29

meeting with the client um it's a great

play44:32

opportunity again to establish that

play44:34

sense of rapport of team

play44:37

of being an extension of who they are

play44:40

of mutual respect and and really

play44:42

respecting all the knowledge and

play44:44

information that they have to date on

play44:46

their drug or device that we can

play44:48

use to make sure that we're really doing

play44:51

the best that we can

play44:54

and that's just a great opportunity to

play44:56

just do a lot of

play44:57

data sharing and so forth

play45:01

and

play45:02

i think just setting it up yourself up i

play45:05

mean from a cro perspective again just

play45:07

kind of

play45:08

um

play45:08

you know indicating and we just like to

play45:10

let them know that like we really want

play45:12

to be sort of a somewhat seamless

play45:14

extension of their team um and experts

play45:17

in the clinical operations realm um that

play45:20

we can really help them and we can

play45:21

really partner with them and look at

play45:23

their very unique perspective because

play45:25

sometimes we're working with clients

play45:26

that

play45:28

might be it might be their first

play45:29

clinical trial and so you know they

play45:31

don't have a lot of that knowledge they

play45:32

might not have an expert in clinical

play45:35

operations on their own team and so we

play45:37

really want to bring that to them and

play45:38

ensure them that we have the experience

play45:41

and expertise um and from the sponsor

play45:44

side as well i mean depending on how you

play45:46

work um you know i think again you know

play45:49

kind of coming from the zero perspective

play45:50

just

play45:51

um having that collaboration is is very

play45:54

important so

play45:55

from the sponsor perspective as well

play45:57

just kind of um

play45:59