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

Summary

In 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.

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

all right ken we lost your um special

music play in there i think we were all

gonna maybe have a nap with that stuff

hi everyone um on behalf of agatha and

dcs clinical services welcome to the

webinar how cros and sponsors improve

tmf management with a shared tmf i'm

really excited to see everyone here

today lovely to see so many people

coming online my name is barb and i'm

here to kick things off

i don't do the presenting i just do the

housekeeping and helping you if you have

any issues

so let's go through the housekeeping

tidbits first so that we can get things

moving um first of all we are recording

so you will get a copy of the replay

and if you weren't able to attend then

you're getting a copy of the replay as

well and we will share the slides out so

you will get the slide deck as well

if you have questions ask them

throughout the presentation or

throughout the talk between ken and

kerry put them in the q a section if you

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

both just in case questions come into

both and ken and kerry will take

questions throughout the session and not

kind of poke in and

kind of talk to them when i think that

you've got something that really works

well for them

and

other than that there is a survey at the

end of the webinar that i would really

appreciate if you all took the time to

fill out

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

going to turn it over to ken and kerry

take it away ken

thanks barb

i'm definitely insulted that was

carefully chosen music but apparently

not invigorating guns and roses next

time i warned you about that

hi everybody hey thank you for joining

it's really nice to have you

i'm so excited about this topic i i am

anyway and then i found it really

resonated

with an audience there's more than 80 of

you who have connected

and we're um

we're just going to dive into this topic

of cro and sponsor collaboration extend

it to the sites as well talk about the

role of technology

it's fascinating for me i consider

myself a technologist

so i look at problems as how can we put

in place the technology to connect

people to

automate processes so that's where my

brain lives

and then there's the people side uh well

these are companies cross our companies

sponsors sites and they're people and

making it all work is really interesting

and i've been fascinated by this

especially cros and sponsors around the

tmf even down to the fundamental issues

of who gets to choose the dmf is it the

sponsor or the cro and who pays for it

and how does that work so all these

topics are very interesting to me

and i'm really lucky to have carrie

brown joining me uh carrie's the senior

director of clinical services or

clinical operations at dzs

i've been working with dzs for a couple

of years now they actually are an agatha

client

but they have of course many of their

own clients um sponsors and they work

across sites

and she as the head of the team

really deals with the sponsor cro

and site nexus

and making that work

she also brings a background that goes

beyond dcs and that's always interesting

she's worked with some bigger farmer as

well as you'll see

at baxter and kendall we're connected

from a few geographies i'm up in new

hampshire

barb is in canada and carrie's connected

from snowy colorado today

our approach today is more uh well it's

not more it's a balance between a

presentation and almost a webcast style

so you'll see fewer slides

a little more talk hopefully a nice

bounce for you i make only one promise i

can't promise you'll learn something i

just can't promise these things i can

promise

this should be the most relaxing part of

your week so sit back relax and we'll

chat for 50 minutes or so i do want you

to take a poll first this is one of two

if barb will put it up we just want to

know who's out there are we speaking to

mostly cross sponsors sites site people

or other so a real simple one would you

describe your organization as

the first choice a sponsor of clinical

trials typically a drug or device

manufacturer or biotech

number two a cro or other specialty

service provider someone who serves the

industry by managing clinical operations

and clinical trials third a clinical

site or you represent a collection of

sites a site management organization for

instance or other

you're just visiting that's fine too so

really interested in that we'll give it

a second i think barb you can tell us

when you have a

plurality of the right number of people

to show the result

yeah we'll just give it a couple more

seconds

well we have just a quick pause i'll

just say hi and i'm thankful that i have

the opportunity to do this together with

ken and agatha and

um and i'm happy to be here and excited

to

relay information and sort of um our

thoughts as well from a clinical

operations perspective on how we manage

the tmf and um you know hope that we hit

on some topics that you're interested in

but certainly ask questions um so that

you know we're

you're walking away with some some

information and an answer to a question

that you have so

um glad to be here perfect

so the results are here you can see the

percentages and it's ideal we have

a split between sponsors and service

organizations almost evenly uh some site

people mixed in and then others we won't

worry about the others as i said

um so we can have a few perspectives and

that's just perfect

i also sent out if you can click can i

close that bar with you

we also sent out uh or i sent out a

personal request for some input from the

audience on this topic and whether to

cover more

the relationship aspects in general or

the technology around the tmf in

specific and i got back of course a mix

of answers and the result is we're going

to cover both we're going to start at a

high level and then drill into the tmf

so carrie um well first to the audience

you're going to see these topic slides

and think of these as the chat areas and

there'll be a few slides mixed in for

this first chat

area i know you just started your

introduction but can you just tell us

all a little bit about dcs so we know

where you're coming from uh do you deal

mostly with smaller or bigger companies

what kind of trials just anything you

can give us for content

fair sure

um so dzs

we consider ourselves a mid-sized cro

um

we tend to work with smaller to mid-size

device and drug companies so not

necessarily we have worked with some of

the bigger named well-known names

companies but we tend to kind of focus

on the small and mid-sized companies

we do provide a full spectrum of

services so all the way from early

clinical development um consulting and

and input and analysis all the way

through clinical operations um data

analytics including data management and

stats uh medical affairs and

pharmacovigilance

i would consider dc as a very technology

driven company we work to really find a

good fit for our clients and their needs

and we look for systems that are very

robust that are intuitive

dynamic and cost effective

you know which is exactly why i guess

we've worked and landed on agathon when

we have input with a client as to which

tmf to use it's one that we recommend

because it does cover all those bases

and is a very nice cost-effective

solution for our clients that that don't

always have um large um bulks of funding

and so forth so it works great and then

just um quickly i guess we pride

ourselves on just providing really great

customer service and communication and

we work best and really like to partner

with our clients so that's emphasis on

partnering so

we really like to kind of be an

extension of their team

well thank you very much for that um

that's a perspective i wanted everyone

to have i as a

one of the leaders in a technology

company bring as i said a certain

perspective we also tend to work with

smaller organizations less with the

largest pharma

a lot of younger companies who are

building out infrastructure

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

last thing i wanted to do which was to

say hi to a few people and then we'll

really jump in because i scanned the

list and

i think bob marley said a few good

friends along the way that i've met so

nice to see some of you here i think

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

say your name we've just had an

extensive email conversation so thanks

uh victoria um working together all the

time so nice to see you in there uh two

more uh sama um well known to carrie as

well as me and then lastly um julie burt

and audrey

just new friends you might say that i've

made along the way so thank you guys all

for joining and i do hope i deliver on

it will be the

it's not good english but the funnest

part of your week or at least the most

relaxing maybe not fun about relaxing if

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

fun no that's not

um so i want to jump in topic number one

of four the critical relationship

between the stakeholders and i wanted to

get carrie into the mix right away and

set the stage this way

we're going to talk about these

relationships and i'm asking carrie to

envision in her mind

a particular sponsor that she's worked

with around some trials and i want her

to just

uh romance that for us tell us how

wonderful it was and what made it

wonderful so i want to hear about the

best

project you've ever worked on with a

sponsor as a cro

sure sure

um so yeah i can think of a couple

clients thankfully that we've had the

opportunity to work with that have just

been really great working relationships

were

considered an extension of their team

they they almost don't differentiate us

from their own company

and they really

bring a lot of respect and um

to us and our opinion and the expertise

that we bring

there's just a mutual

trust

knowing that we will provide them with

clear up front communication and

expectations um

and it's just you know a great

collaborative effort where they really

appreciate what we have to say and what

we do

um and it just provides for a great

working environment everyone's really

working their hardest to

to

do their best for the client so

trust is such an interesting and

important part of it all of course as a

technology provider we have customers

and we implement software solutions for

them and trust just looms very large

because if you start with trust

then even if something goes a little

awry you can work it out easily if you

start with uh less trust

it can get difficult right away and with

that as the intro to what i'm going to

ask you now it's kind of rude of me

because we'd like everyone listening to

say every dcs relationship is perfect

every sponsor is perfect it's a love

fest so let's talk about before you were

at dcs maybe some project that you

remember

that was more of a horror show where it

just was a really difficult environment

can you tell us a little bit about that

and why you think it was that way

sure um yeah i mean unfortunately i've

been in that position it's not as much

fun it doesn't make for as much fun at

work

um but it was more uh sort of

adversarial i'd say um where they kind

of made it clear that they were the the

client they were the sponsor you were

the service provider you know it was a

separate entity you were there to

provide to them um specific services

um and it just kind of had a tendency to

put you on the defensive um i think it

kind of led to um

you know really

laboring over every word that you wrote

or uttered to make sure it wasn't

misinterpreted or twisted in a different

way so just made it a very challenging

environment where a lot of energy was um

used and focused on the minutia and i

think that in kind of stepping back from

that since that time

looking sort of lessons learned i think

that it didn't allow the team to really

look at the big picture and i think you

kind of really lose

um

lose something when you're so

focused on the details and making sure

you don't make any single small misstep

that you kind of lose the big picture of

the of of the of what you're doing in

the service you're providing so can make

it more challenging for sure and more

stressful

really interesting to me the uh the idea

that you know you have energy a certain

amount of energy

on the team and it can go into solving

the problems for the patients for the

trial driving exclusion or you can use

up a lot of that energy internally

in any company we know that i call it

internal stupidity when people are just

acting stupidly

excuse my language internally rather

than focusing on what we need to do

which is deliver for the customers and

that's true the sponsor and the cro um i

was also thinking and i know i mentioned

this to you carrie earlier i actually

did the research afterwards this whole

observer effect thing for those of you

who are physicists you know more than i

do about quantum mechanics and quantum

physics and schrodinger's i can't say

his name cat and all that but if we

observe things too closely we affect

them

and so when people drill down and

they're watching every step of what they

do

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

just thinking of a simple thing like uh

having i

have a

an antique car that's being restored and

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

the mechanic makes mistakes he wouldn't

make if i wasn't watching you know

nobody wants to be watched that closely

so it goes back to trust again which is

interesting

so with those two examples excuse me i

went an extra page carrie can you just

run through these five things that i

think you

summarized as these are what you really

need to focus on to have a good

relationship from the outset

sure sure

so i think just having clear

expectations set really early on through

um you know that can be through detailed

roles and responsibilities it can kind

of be set in other ways as well

um but i think that that's really

important so everyone comes to the table

knowing sort of who's doing what and

um and and how you know how things are

to proceed so i think that's really

important and for those of you that are

on the cro side that are more of a

service provider you know i do feel like

it is sort of our

role to drive that process and to

really you know review carefully the

statement of work um

through the kickoff meeting and kind of

relay that in that meeting with the

client and just make sure that it's

talked through and everyone is very

clear on those roles and

responsibilities um the next thing as

i've mentioned i guess um in sort of a

good relationship that we've had before

or i've had with a working with a client

is just that mutual respect for the

expertise that each party brings to the

relationship so obviously understanding

you know again i've got sort of my sero

uh lenses on so through my cro lenses

it's sort of you know obviously

respecting the fact that the client

knows their device they know their drug

in depth and you can really gain a lot

from

tapping into that so that you can really

understand their product and and and

their history with that product and can

use that to to just better your services

and what you do and how you do it

and then also hopefully from the other

side that they can really um the clients

can really respect that as a cro or a

service provider you really bring a lot

of knowledge about that clinical

operations aspect of things um and have

done

operations numerous times across

different studies and therapeutic areas

and so forth and can really

appreciate what you bring

from that perspective

um

the next one honest and open

communication again i think that's so

critical

um you know sort of things come up right

no one's perfect and so uh things come

up and we all

make mistakes unfortunately we're human

and so it happens it's our human nature

um so i think you know especially for

that just being able to have honest and

open communication with timelines if

they're slipping and so forth having

that really being able to have that

really honest open communication um

coming to the table i think as a cro or

service provider it's important to come

to the table with solutions or

corrective or preventive actions that

you're already

establishing for anything that might not

be going just as planned

so i think that that's really important

i think kind of doing ongoing lessons

learned throughout a trial as things

come up and you realize you know maybe

it wasn't a complete mistake but maybe

it was something that could have gone a

little bit better than it did and having

those ongoing communications

and collaboration i think is very

important um

right we hear so much about just having

visibility into things um

is such a buzz word these days and so i

think really uh

communication can kind of help to aid

that so they really feel comfortable

that you're gonna bring things forward

and they're not gonna suddenly find out

um late on later on that something

happened that you were trying to hide

um

collaboration i think is important you

know and that kind of all these

different things kind of cover that

really from start to finish you know

that it is a collaborative effort even

if they've really assigned a lot of the

responsibility to a cro it is important

to collaborate and you do need uh the

client input as well on on numerous

things and then just working with the

shared purpose like what is the goal

what are we all working for let's um you

know work toward the same purpose

well thanks it's a

interesting list and of course the thing

jumping out at me is collaboration

because once again from a technology

perspective i'm focused on how do we

enable that collaboration we can't force

it but we can make it easier and i think

it happens not just in the etmf

but other systems so i had asked harry

to put together a list

excuse me

still having some trouble with my order

here

we'll be there in a second

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

i keep hitting the button too many times

a list of technology areas where cross

and sponsors do interact i shouldn't

just said technology carry just areas

where they interact so this was your

list of these are major points of

interaction and collaboration is that

right

yeah right where um you know it can't

just be driven by one side or the other

i mean um you know even for instance the

first one with protocol development even

if the sponsor is really doing the

writing the protocol and that's not a

service that they've um

asked the cro to to participate in i

think we always welcome the opportunity

to review the protocol before it's

completely final and provide some input

as far as our our um

uh perspective on operations and so

forth so but either way um you know i

think both both sponsor and cro can

bring some really that a lot of value to

developing the protocol uh and making

sure it's a good solid protocol that's

realistic and the sites can follow and

so forth um and then study plans and

these are just so important um

[Music]

just

uh to make sure that everyone again is

sort of on that same page and making

sure everyone's clear on roles and

responsibilities and exactly how

we're gonna carry out the different

functions that have been delegated to us

so as a cro so i think those study plans

are very important to make sure that

everyone's in agreement with the way

that the

study is going to run

that can be your project management plan

your tms plan a data management plan

there are lots of different plans that

go into

kind of laying out the expectations and

how the study is going to progress

and then case report forms obviously

we want to make sure we're collecting

the data that's going to be needed by

the cro so this is very important to

have some collaboration on

and the statistical output is incredibly

important just

both how we're going to do the analysis

as well as what the ultimate

tables listings and figures are going to

look like which

dzs i guess we present those through

mock shells so that the client can kind

of see exactly what the output's going

to look like and what information we're

planning to display in those final

outputs

and then of course the tmf

which is you know the

tells the story of the uh clinical trial

and then so that needs to be a very

collaborative effort as well

i find the list interesting because some

places i know the system that's used

study plans might be a ctms for instance

uh statistical output might be

at least part of it related to an edc

system

i see collaboration tools for protocol

development and

for board reporting the tmf is

interesting to me because one of my big

theses is

it tends to be thought of as a place to

put stuff

and my argument is that's very

old-fashioned thinking it's not a place

to put stuff it's a place to do stuff

and that's really the focus as we go so

it's a

good transition into topic number two

so who's tmf is it anyway

um

this is one of the things i previewed

excuse me early on in our discussion

today

but there's something i know because

i've read it

legally the tmf is the responsibility to

sponsor it is their

responsibility regulatory if i can say

um to make sure there is a complete tmf

et cetera et cetera

but of course many times it's delegated

to the cro

so help me out carrie what's more

typical

is it often owned by both or managed by

both i'm using the term own probably

incorrectly but

tell me in real life how you work with

sponsors around a tmf

sure

i mean i've kind of worked in a couple

different ways i mean sometimes the

sponsor has their own the client has

their own tmf system that they would

like you to use um and they might you

know control access rights and so forth

in the setup of the tmf through their

i.t department or another functional

area within their team or they might you

know want you to provide and house the

tmf

set it up provide access rights and

remove access rights etc so kind of can

go either way

um as far as that goes but then um

then it does need to be a collaborative

effort and generally we've worked with

some clients where they pretty much

delegate the rest of the tmf management

uploading documents into the system cue

seeing them doing an overall qc of the

tmf

to the cro

but i would argue that there needs to be

some role of the sponsor or the client

in the tmf even still

and we have had clients that have

you know we do the document loading we

qc the documents but they do some of the

overall qc of the tmf and that's a great

way to do it i mean i would argue that

the client really needs to know their

tmf um at the end of the day like you

said legally they're the ones ultimately

responsible for it and accountable to it

and they may have to answer questions

about it right so they really need to

know the tmf and be familiar with it so

i think involving them in the process

perhaps just through a very um

infrequent qc and as the cro or the

client you can do a more frequent qc um

but having them participate or be

involved in that in some way i think is

really helpful

um as you mentioned i guess and i agree

that it's ken not just a place for

documents to reside

um

but more and more the tmf as we're

hearing from fda

they expect the tmf to tell the story of

the clinical trial um and i'm hearing

more and more that in some instances the

fda is just asking for access to the

etmf

um to do their audit and then they're

auditing the tmf and they're not even

sometimes speaking to

um

the sponsor or the the cro that may have

been involved in that they really expect

the documents to stand um for themselves

and collectively to tell the story of

this of the of the trial and so i think

it's it's even more important than it

used to be for the sponsor to be

familiar with it

um and understand that story

we're going to be picking up on that

thread but you just expanded the

stakeholder group in a very interesting

way

of course

systems like agatha's allow an auditor

to

have a selected view of the contents of

the tmf for audit reasons so of course

we're aware of that but when i think

about collaboration i think about

collaboration between cro sponsor and

sites but it's also the regulator as

you're saying the system is at the

center of a lot of conversations and

activities and processes

so that's almost the whole story for

today and we'll keep coming back to it i

want to take a quick moment and do a

second poll it is the second of two and

it's again just to get a sense of who

we're talking to so we can dial in our

conversations um so barbara if you can

throw up this poll it's about your

current approach to trial master file

content and it's in your

organization do you use paper

spreadsheets and shared folders or you

know people say it's paper-based but i

think they mean number one

number two is it uh something like inbox

dropbox a shared folder a shared drive

it's a place where you put things

uh sometimes those are called sync and

share systems number three no it's an

etmpf an electronic trial master file

application or system of some sort

or number four

not applicable not what we do or you do

it a different way that i haven't

thought of which is certainly possible

so if we can take a minute and ask you

folks to do this poll

uh we'll watch the answers and barb will

let us know when we have

a quorum

and then we're going to go deep diving

on etms topics

for the next 20 minutes or so

it says i cannot vote

host and panelists cannot vote okay

i think that's restricting my voting

rights but

be careful of the politics i suppose

we'll go down that avenue

so what do you think barb you have

enough to share some results with us

yeah um

one person said they couldn't vote so i

don't know if anybody's having trouble

being able to vote but um which is weird

because you should be able to but

there's where we we ended up

okay so

very interesting uh this will be

interesting with carrie because we've

talked about it before that a quarter of

you do use sort of um

paper spreadsheets shared folders etc

50 do have an etf in place of some sort

it's a small number of inbox dropbox or

a similar system that's interesting

because a fair amount of agatha

customers do come to us in that

situation we have folders they are

structured to reflect the etmf but

they're not controlled so we have

duplicates and other problems and then

other or not applicable so that's who's

out there carrie as we talk through the

rest of this

and as i said we do our deep drop dive

on

etm conversations

so what i want to talk about is

excuse me

drop page

that

we want to think about

technology in clinox

in a certain way for the rest of our

time together so i'm going to share a

picture

describe it and then we're going to come

back to it at the end so be patient with

me for a second

but it's this picture i call it the

clinops

technology adoption curve on the bottom

left you'll see basic tools

like spreadsheets

shared folders etc so that's what i

think of as a stage one adoption in

clinops

stage two core systems you start to have

an etmf maybe a ctms an edc system again

the alphabet soup of systems available

for clinical operations um stage three

yeah just not just those systems but

things are starting to be automated and

interactive between the stakeholders

stage four yes we have a lot of systems

and they're connected the processes are

connected and stage five is sort of this

nirvana stage fully digitized if you ask

me do i know any companies that are at

stage five my honest answer would be

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

fully digitized with lots of issues so

no reason in heaven yet from what i can

tell um so that's the

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

back to that

in just a little while

what i want to do to to get there

is share a couple of slides this is what

i was saying carrie about

thinking of the trial master as simply a

central filing cabinet this is how it

all started it's a place to put things

and the documents are

meant to tell the story of the study as

you said

over the years we've gotten a standard

reference model so all of our tmfs are

relatively similar

although of course they have to be

specific to your study

and it may be

managed by the sponsor managed by the

cro

or a collaborative space but it's still

just a place to put things

and my vision is i know this slide

doesn't say much but i'm trying to

capture the idea that the tmf is one

critical system for interacting

along with other systems that you named

you know there has to be a dashboard for

the study whether it's out of a ctms or

a tmf but it's something that's telling

every all the stakeholders here's where

we are

so dashboarding and metrics are are key

to that interaction

and lots of other systems as well so

that's my

hoped for vision another way to show it

is this way with the trial master file

at the center

of a lot of processes

yes for documentation but also

for simple

communication as i said dashboarding

even just notifications tasks do et

cetera collaboration

where there might be work on a document

that requires several people to be

editing at the same time and the tmf has

to support that while supporting the

regulatory requirements that there's

only one true copy eventually

for monitoring activities so when we

think of the tmf and we extend it to the

site side for the investigate site

files there's monitoring and there's

quality processes for the tmf as you

just mentioned

so coordination process management the

tf tmf becomes this engine rather than a

place

and that is as i said sort of my my

central

thesis

of what we're trying to do here now when

you look at this carry you see this

picture

is that like yes ken you're absolutely

right or

come on ken that's not really uh a valid

picture of where we're going to get with

the tmf i guess i want to say more

simply am i overplaying the role of the

tmf as this engine of collaboration or

do you think it has a central role in

keeping the stakeholders connected

yeah no i completely agree i think it is

um very central to to what we do it can

be a very powerful tool for

collaboration

um you know within the agita system

there's a way um you know i guess from

my perspective against zero um you know

as you're creating your plans and so

forth there there are points in time

where you're not quite ready to share

those with the client you're not quite

ready to to have their eyes on it um but

once you kind of get to that point like

a final draft if you will an internal

final draft of a plan

um the tmf is a great place to then uh

upload that you can upload it as a draft

into your system specifically and i'm

sure others as well

and then you can send that to review and

so there's a great way to um collaborate

within the system for the client to

review those plans and provide their

comments changes and feedback through

that system so it's all kind of tracked

with metadata and version control and

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

way to collaborate um it gives them the

tasks and the due date that you assigned

to it so it kind of gives some

accountability and so forth and just a

way to um kind of keep that out of your

inbox you know with things going back

and forth and there's a lot of issues

sometimes with version control

and it's within a very a compliant

system right so you don't um

so you don't have to concern yourself

with that and then certainly too i guess

one of the other things that really

jumps out at me is the monitoring

perspective of things so when you add

the uh electronic investigator site file

to all of this that just really makes it

all kind of come together right you can

look at their

essential documents within their site

file as the cra and then just transition

them if they're if you review and

approve them you can just transition

them right into the tmf um or you can

give them comments and feedback if they

need to adjust or modify something

within that document and then it

provides the opportunity for monitoring

right because within the investigator

site file there's a place for them to

put documents such as source files and

medical record files

and even the informed consents that have

protected health information that are

very protected folders that only the

monitor assigned to that site can view

they cannot download they can't save um

they can only view those for a limited

period of time

and then they no longer have access to

those so

it really just becomes yeah quite the

the hub for

a lot of what we do

actually looked for a picture of a hub

but i couldn't find the right kind of

hubs i had hubcaps and other hubs but i

didn't have the hub i wanted but it is

kind of the vision that i have the hub

at the middle of a gearing

system i'm worried because you're

encouraging me and i consider you a

realist you know you're you're out there

every day working on trials with

sponsors and

you're buying my vision here so as i

said you're encouraging me which just

means i'll go further

and starting to think of the etmf as

part of sort of a digital decentralized

trial process if you take that curve i

had up a minute ago it takes you right

into

the third phase of

technology adoption which is fully

connected

processes

workflows collaboration

shared

development of new items etc so that's

kind of as we round the curve towards

the last part of our session where i

want to focus and

talk a little bit about how to do that

what does an etmf have to have in it the

system to enable this kind of thing

so

you can tell i went backwards i

apologize

so now i get really crazy i'll try to

describe this picture but carrie you

were saying on the right hand side you

have sites

and sites need their own isf files they

they don't want to be

you don't want them in the tmf itself

they need a self-contained space to

upload their documents so even though

it's in the cloud each of those isf

icons belongs to a site

and that's how it should be and how it

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

bit strong but it should be because

they're responsible for those documents

not not you they're they're documents

they're the site

but you want to monitor and oversight

them so the cro on the left have lines

going into

those isf files where

they can

see documents that are ready for them to

see

and they can do oversight they can do

monitoring they can do quality

inspections just as they would if they

were on site

so that's starting to really enable a

digitized model where everyone's

connected through a shared

system a shared architecture

meanwhile the sponsor on the lower left

has roles too

notice the tracking and reporting

because the tmf we want to keep track of

what's still missing what percentage is

done which sites are at what percentage

complete

and they may be involved in those

workflows in the middle they're

reviewing and approving

because there may be protocol amendments

that need to be reviewed and improved

and the idea is to take it out of email

take it out of excuse my language god

forbid facsimile and get us to the point

where

these interactions

are seamless they're automated and

they're tracked

and that's the key because we always

need to keep track of what version

who said what

who signed off on it and that's what the

etmf needs to do so as they say this

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

a space to drag and drop things in a

folder this is a system to manage

relationships and interactions

support the trusted environment so that

there's less drop balls and there's less

of those human errors that you were

talking about carry in my view this goes

a long way towards improved quality

as well when we have a system that

captures all the interactions probably

shouldn't say all that's a technologist

speaking there'll still be always other

conversations etc but the majority of

interactions

so i wanted to cover a question that i

was asked ahead of time when i said what

should we cover and it's what should a

etmf have in it and i decided to do it

in two slides this is the basic

agatha and virtually every other

respectable vendor can do these basic

things they can show your 21cfr part 11

compliant they can tell you what's

missing at any point that hasn't been

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

probably based on the tmf reference

model it controls versions controls

access allows you to collect electronic

signature

so all of those will call fundamental

capabilities of any etmf but what about

a fourth generation etmf that supports

the kind of vision i was going through

this is what i've added

we're connecting the sites themselves

each using their own isf workspace but

all connected to a bigger picture we're

using it for remote monitoring as carrie

said there's collaborative authoring

capabilities so that you can edit the

same documents uh in place

in the system

and keep track of those edits comments

so that we evolve to a complete version

there's review and a work approval

workflows task assignments for instance

from a monitor down to the site correct

this document

and there's dashboards because the

dashboards are critical for that

collaboration so with these six things i

think you get into the model of a fourth

generation etmf that's much more than a

place

and it really is a system to track and

manage processes

does that all make sense to you carrie

yeah no it makes

perfect sense

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

last thing to chat about with uh with

you specifically

um

this vision of a fully automated system

uh is my vision and i have customers at

agatho who have work i'll go back to the

grandiose picture um who are very close

to this now

who agatha has a remote monitoring

solution for the site side we have an

etmf so we see people doing this

carrie in your mind can you think of a

highly technology a droid customer of

yours that's approaching this kind of

world are your customers or any of your

customers getting towards this vision

yet

sure i can think of one in particular i

guess doing a couple different studies

with uh set up a little bit differently

um

there's one where they are you know

really doing this they have the etmf um

they're using the agatha tmf i think

because we introduced them to it and

they are

um having their sites use the electronic

investigator site file

just which really you know

aids in that remote monitoring aspect of

things and

um i don't know while you were talking

ken it just popped into my mind my um i

might be dating myself but going out and

monitoring at the site reviewing their

paper regulatory binder trying to

reconcile all the correspondence

um you know which is just plentiful and

lots of emails and things just kind of

difficult to name and track and keep

track of and and how much easier it is

with an electronic iff right i mean

you're really looking at it and you're

just moving it over to the tmf so you

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

just makes you know that particular

aspect of things a lot easier and and

granted some of that correspondence

isn't cree isn't critical documentation

but some of it's important to the trial

and and they are supposed to be a mere

image of one another so you do need to

do that um reconciliation so that just

kind of popped into my mind but um

with the same client i guess them

they're actually i mean they're probably

as close to nirvana

stage five as you

described though you know in my mind you

know it's like giving someone five stars

like can anyone ever really earn the

five stars like can anyone ever really

get to full

digitization but

um

this particular client is doing a fully

virtual trial with a with a virtual site

um the patients are e-consented remotely

they just do remote visits um they have

a device and and tests that they do at

home on a virtual call with the site um

to make sure that they're performing

things and using the equipment and so

forth directly that data gets

automatically recorded by the device and

the different systems and into the cloud

you know it gets transferred to us

electronically to to analyze all that

data for the ultimate statistical output

and so forth so um and they're using an

electronic tmf and that virtual site

in this case has their own version of a

electronic site file so um

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

full digitization like no one's actually

it's very coveted safe we'll say

no one's actually coming into contact

with one another

yeah and a lot of this moved very fast

with kobe to push us all into this kind

of a vision well that was nice because

you kind of said yes ken there is a

heaven so i kind of like it

i do want to now do a jiu jitsu to

everyone sorry if that's not the right

term

we started at high level conceptual

relationships between the stakeholders

we got into the technology talked about

the etmf i want carrie to have the last

word now and what i've put together is a

hypothetical if you will

carrie is a picture her uh

in her evening

outfits she's at a party and she's

introduced to a

little bit younger person who says i

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

not a a sponsor or a cro it doesn't

matter and i'm about to start my first

study and i'm nervous about the

relationship i want to make sure we

really do this right what's your advice

to that person carrie what does she she

or he most have to get right at the

start of the relationship

sure well i think i think you know just

building good rapport like kind of

setting up that report from the start is

very important i think you can really do

that um and at dcs as soon as we're

awarded a study you know we do a kickoff

meeting with the client um it's a great

opportunity again to establish that

sense of rapport of team

of being an extension of who they are

of mutual respect and and really

respecting all the knowledge and

information that they have to date on

their drug or device that we can

use to make sure that we're really doing

the best that we can

and that's just a great opportunity to

just do a lot of

data sharing and so forth

and

i think just setting it up yourself up i

mean from a cro perspective again just

kind of

um

you know indicating and we just like to

let them know that like we really want

to be sort of a somewhat seamless

extension of their team um and experts

in the clinical operations realm um that

we can really help them and we can

really partner with them and look at

their very unique perspective because

sometimes we're working with clients

that

might be it might be their first

clinical trial and so you know they

don't have a lot of that knowledge they

might not have an expert in clinical

operations on their own team and so we

really want to bring that to them and

ensure them that we have the experience

and expertise um and from the sponsor

side as well i mean depending on how you

work um you know i think again you know

kind of coming from the zero perspective

just

um having that collaboration is is very

important so

from the sponsor perspective as well

just kind of um

coming at it from that perspective and

really um

working to you know build those

relationships and um build that trust so

that you know that that communication

will be forthcoming and um and there'll

be that visibility into what's happening

with your trial

maybe it's why we have hit it off over a

couple of years and we do so well as

partners dcs and agatha

had never really thought about how

similar our businesses are but when we

have a new customer we have to implement

that software and get it into production

and validate it so it's a project just

like a

study is

and so much rides on those first

interactions and establishing that

rapport and relationship and trust

you can really mess it up if you don't

invest

at the front in those relationships so

my big thing is in the transition as

you're getting started with kickoffs

take your time make sure as you said in

a slide roles are clear spend a little

time saying so how many kids do you have

just build relationships and it really

pays off because sooner or later

there'll be harder conversations and if

uh if by then you have rapport it's

gonna end trust it's gonna be a lot

easier so makes a lot of sense and i

know that's what dzs does

as a business certainly what agave tries

to do so as i said maybe that's why

we're

compatible

as we wind up i wanted to make sure the

audience before we take questions knows

of two offers barb you did put a qr code

in aren't you hot

um

this is uh an available white paper or

e-book i believe it's written as

which was authored by a collaboration of

people including barb carey myself other

people at dcs

and it describes

how we think cross and sponsors

can leverage an etmf for collaboration

just think of it as the hard copy

version of some of what we were just

talking about and i'm assuming barb if

they take their phone out capture that

qr code in their camera and click a link

they can download that as i said that's

pretty hot

alternatively you can go to the website

for agatha health.com or you can send me

an email so that's one offer but the

other one the next one i'm really

excited about i had showed you that

technology adoption curve

here

about these different stages and i won't

call it academic work but it's thought

work that i'm doing

and trying to understand how to classify

companies and based on where they are in

the adoption curve and who they are

small large sponsors small organic what

are the right technology investments

next what will pay off the most to move

up the curve deliver the most value

so here's the offer i'm looking for 10

or so organizations to work with

what i need is two to three hours

to do kind of in-depth workshop

interviews can be under non-disclosure

i will get what i want which is

understanding different profiles of

companies and start to place them on

this curve but what you'll get is an

audit report that places you on this

curve and based on where you are in your

type of company and my own insights your

insights

an audit report that says here's the

what we recommend for technology

investments i'll give you an example

many of our customers say do i need a

ctms and my answer is i don't know

depends on where you are and what you're

doing and whether that's on the critical

path to what you're trying to do um so

there's questions like that that i think

can be answerable in a somewhat

organized systematic way

so if you're interested in a free audit

to place yourself or have me place you

on the technology adoption curve small

audit report probably 10 or 15 pages of

here's our findings here's what we

recommend i make one promise it won't be

self-serving this won't be i don't care

who you are you need agatha it won't be

that i promise um i really want to do

this as

quasi academic work um and learn from it

so if you're interested in that and

collaborating with me

then drop me a note my email is on the

screen right now ken dot lowney at

agatha health.com

or um through our website at info i got

the health and carrie you don't know

this but if we get invited to do a

couple of these i might ask you to sit

in and chat with them as well i know

you're busy but might be interesting

we'll see whether i can trick you into

that

as we um wrap up completely we didn't

take any questions during the session

which i was expecting but it didn't work

out that way do you accumulate any

questions that you want to share

we have lots of questions and i just

assumed the flow was just going so well

i chose to kind of hang on to them so

hang on now you ready to go

ready

all right first one's for carrie dong

says what percentage of your sponsors

don't have their own tmf and need your

services for a tmf

um for us in particular again i

mentioned earlier i guess that we tend

to work with smaller mid-sized clients

sometimes it's their first for foray

into clinical research or clinical uh a

clinical trial um they've done

pre-clinical work and so forth so it

so in general for us we are the ones

that are actually sort of housing the

tmf for them and and

recommending the tmf um

you know to that that we're most

comfortable with and that we feel is you

know robust and dynamic and cost

effective and so um often you know i

would say gosh it's probably upwards of

75 to 90 percent of our clients um

probably ask us to actually house and

hold the tmf itself

cool okay before i go to the next one i

just want to so i tested that qr code

and that qr code worked so jessica i see

your note that it didn't work for you

i'm going to assume it's because i

noticed that ken's screen is a little

cut off maybe that's the problem but i

apologize if anybody

you know had that nice qr code and it

didn't work i swear to god i tested it

i'm not i'm not impressed with myself

like that

i just changed this it just changed the

scale i'm sharing more on my screen if

someone wants to try again

yeah it might work if not i'm annoyed

because i did test all right next

question um

so from murvy how do you see long-term

storage of the tmf for example when a

cro has a digital tmf application and

the sponsor has part 11 compliant

document management system

will the tmf create a compilation of

documents that is easily transferred to

the sponsor's system

did you call me out or carrie it doesn't

matter but i have an answer it's for

either one of you

go ahead ken

thanks

um

so some basics to cover any reasonable

tmf system today

allows you to both import and export

documents in structured way um

i'm not trying to sell you agatha but as

an example agatha lets you export

everything in the tmf at any point not

just when it's finished

in a zip file that's fully folder

structured and everything's in pdf

format so that's pretty

essential capability now when a study's

over

what our customers typically do there's

lots of paths here but they typically

leave it in agatha for a short period of

time in a frozen state not alterable and

then they'll export it now once it's

exported

that can live on a flash drive it can

live in a shared folder it's it's a zip

file it's a very large zip file but it

is a zip file but most traditional

document management systems if i'm back

at the sponsor side

and they're using i'm just trying to be

amusing here they're using a dinosaur

like documentum opentext filenet

something like that those systems should

be able to take in that exported file so

i hope that made sense sometimes we do

it as a synchronized experience meaning

someone's using agatha they're building

a uh tmf and at periodic times they

export and upload to the sponsor and the

sponsor takes incremental builds of it

i'm not sure

why uh probably a process

regular not regulation internal process

but that's what i see

last thing i can say is it's possible to

have a local tmf interact with a large

document management system and have them

exchange the information more or less

real time that kind of integration is

possible in my experience people don't

tend to do it it's quite expensive and

somewhat fragile

carrie i can tell i think i can tell by

your look you have something to add

no i think i i agree with what you said

uh wholly and you know typically what we

do is so far with most of our clients we

just house the tmf for the entire entire

clinical trial and manage it and then at

the end we downloaded it you know into a

zip file as you mentioned and then we

trans transfer it to the client so that

they have the full

electronic system and it does you know

have it in a nice folder structure so

it's kind of like a file explorer

structure so yep

one time for one or two more bar yep

okay so

um a document such as the iv

should a copy be kept in the tmf for

each individual study on the same

compound or could the original document

be kept in a central place to ensure

only one original of the document which

is clearly described in the tmf

so for me it's beyond my expertise i

apologize uh i can get that answer and

provide it but carrie do you understand

the question well enough to offer an

opinion

sure so it's more um trying to you know

because the ib kind of can cover several

different clinical trials that are going

on with that same uh drug

so it's whether you're um

trying to think typically our the tmf

that we usually set up is is kind of by

study

um so in that case then generally the ib

would be in each location but um

uh yeah i'd have to we might have to

look into that a little bit ken i guess

i we haven't set it up that way whether

there are sort of

um even a higher level other than i

think right now they're sort of like

country level documents site level study

level etc um

that are particular to a study and

whether there could be even an

overarching folder that's more of a

program folder for documents that might

uh cover the whole program of trials

with that

particular yeah i understand exactly

sorry to cut you off i understand

exactly um i don't understand

the regulatory environment technology

wise at agatha anyway we can support

that there's a level above the workspace

studies that's called the organization

and the organization could have

documents that are

common to multiple workspaces and

studies so technology-wise it can be

supported i don't know beyond that one

more barb just before the wire

yeah um and just just before i asked

this one a couple of people asked um

about the audit report and um a demo or

how to see what that tmf looks like and

we'll answer those kind of offline just

to kind of so that we're i don't want

you to think we're ignoring them but the

last question i've got here is from matt

how often are you transferring a tmf to

a sponsor system or platform for

archiving after study completion

so i think it's a version of the same

question so i will sound a little

repetitive in the most classic model

uh for us whether it's a sponsor or cro

someone is playing the management role

on the tmf if they're using agatha

they're using it through the life of the

trial as carrie said and then at some

point the trial is over and most

typically we leave it in our cloud in

our environment for a period of time uh

six months a year it lives there because

people might still want to access it on

a read-only basis

then we export it

now matt's question was specific up to

the sponsor and as i said we can do that

incrementally and periodically almost

like for safekeeping

um so that you know there's incremental

versions of it every

three months or something and then

lastly i said you could fully sync but i

i just don't find it practical to fully

sync two systems like that completely

doable technology wise but

a lot of things are doable with

technology that you probably shouldn't

do

not many technologists will tell you

that but i will

i need to wrap up we're at the top of

the hour barb you're a fabulous producer

thank you so much carrie you're an

amazing

collaborator and trusted and a wonderful

guest so thank you this was a lot of fun

for me i hope you guys all had fun we

have another great webinar coming up i

think uh towards the end of march barb

you're smarter than me can you remind me

the topic

oh it's on that adoption curve right yes

yeah it's all about the technology

adoption curve march 24th so i'll make

sure everybody gets the information on

that one if they're interested in

attending that's why i need to speak to

10 of you listening right now because i

need to be done by march 27th and be

able to have a lot more to say about the

technology adoption curve so you're my

informants as they call them in

sociology thank you everybody appreciate

your time see you next time

we're out of here

thank you bye