Trial Master File In Clinical Research Pain Points and Basics Explained By A TMF Pro!
Summary
TLDRIn this episode, David Kovac from Montreal discusses the role of his life sciences tech company, Montrium, in streamlining clinical research through affordable and scalable tools for managing Trial Master Files (TMF). He explains the TMF as the comprehensive story of a clinical trial's proceedings and highlights the challenges faced by small biotech firms in maintaining TMFs, including the transition from paper-based to digital systems. The conversation also touches on the future of TMF with the integration of AI and machine learning for document classification and better standardization practices.
Takeaways
- 🏥 David Kovac is an account executive at Montrium, a life sciences tech company focusing on providing tools for smaller sponsors to manage their trial master files (TMFs) affordably and scalable.
- 🤝 Montrium's core mission is to support smaller biotech companies (10 to 500 employees) with the necessary tools to collaborate effectively and manage their regulated content as they grow.
- 📂 A Trial Master File (TMF) is described as the story of everything that unfolds during a clinical trial, which is the sponsor's responsibility when facing a regulator or auditor.
- 📚 The TMF includes a wide range of documents such as monitoring reports, 1572s, medical licenses for PIs, protocol parts, and follow-up letters, essentially all outcomes of clinical processes except source documents with patient data.
- 📜 Many biotech and CRO operations are still paper-based, using physical documents, binders, and signatures, which can become unmanageable as clinical programs expand in scale and across geographies.
- 🌎 Montrium primarily works with sponsors in the US and Europe, aiming to improve the way clinical research is conducted and enabling better collaboration between sponsors and CROs.
- 🔖 Electronic signing and document approval in a 21 CFR Part 11 compliant way is a significant challenge for those without access to validated tools like DocuSign or Adobe Sign.
- 🤖 The future of TMF involves the application of AI and machine learning to automatically classify documents and maintain file structure, which is a complex task considering regulatory requirements.
- 📈 Standardization and education on best practices, such as following the TMF Reference Model, will likely improve in the coming years to ensure readiness for audits and oversight.
- 📈 Small-cap biotechs are of interest due to their potential for growth and the opportunities they present for investment and involvement in the clinical research community.
Q & A
What is the significance of the Montreal Canadiens jersey mentioned in the transcript?
-The Montreal Canadiens jersey is a symbol of pride for David, the guest from Montreal, and it also serves as a conversation starter, highlighting the不确定性 of future events, such as the outcome of the Stanley Cup.
What does David Kovac do at Montrium?
-David Kovac is an account executive on the sales team at Montrium, a life sciences tech company. His role involves providing smaller sponsors and CROs with the core tools they need to manage their trial master files and regulated content affordably and scalable as they grow.
How would you define a Trial Master File (TMF)?
-A Trial Master File (TMF) is essentially the story of everything that unfolds during a clinical trial. It is a comprehensive collection of documents that a sponsor is responsible for, which becomes crucial when facing regulatory audits.
What are some of the challenges faced by sponsors and CROs in managing a TMF?
-Managing a TMF can be challenging due to the vast number of documents involved, the need for easy retrieval, and maintaining them in a specific format. Additionally, the transition from paper-based systems to digital ones and ensuring compliance with regulations like 21 CFR Part 11 can also pose significant difficulties.
How does Montrium address the issue of paper-based operations in the life sciences industry?
-Montrium provides technology solutions that help life sciences companies, particularly smaller biotech firms, transition from paper-based operations to more efficient, digital systems for managing their trial master files and other regulated content.
What type of clients does Montrium primarily serve?
-Montrium primarily serves smaller biotech companies, around 10 to 250-500 persons in size, who require core tools to manage their clinical trials effectively and collaborate better with CROs.
How has the pandemic influenced the adoption of electronic document management systems in the life sciences industry?
-The pandemic has accelerated the move towards electronic document management systems, as there has been an increased need for remote work and digital collaboration. Tools that enable electronic signing and compliance with regulations have become more important.
What are some future trends in TMF management?
-Future trends in TMF management include the application of AI and machine learning for document classification and maintenance, as well as better standardization through models like the TMF-DIA reference model, which will help organizations prepare for regulatory audits.
How does an eTMF benefit sponsors in terms of oversight and collaboration with CROs?
-An eTMF (electronic Trial Master File) allows sponsors to have greater oversight by enabling them to work within the same system as their CROs. This facilitates proactive communication and ensures that documents are up-to-date, enhancing inspection readiness and overall collaboration.
What is the importance of educating people on best practices for TMF management?
-Educating people on best practices for TMF management is crucial for improving standardization across the industry. It ensures that organizations are prepared for regulatory audits and can maintain the integrity and compliance of their clinical trial documentation.
Where can one learn more about David's company and insights on clinical research technology?
-To learn more about David's company and gain insights on clinical research technology, one can tune into the Latinos and Clinical Research YouTube channel and subscribe to their email list for updates on the tech series and other informative content.
Outlines
🎥 Introduction and Background
The video begins with the host welcoming viewers to a new episode and mentioning that he is joined by David from Montreal. David is introduced as an account executive on the sales team at Montrium, a life sciences tech company focused on providing smaller sponsors and CROs with the tools to manage their trial master files and regulated content affordably and scalable as they grow. The host and David discuss the Montreal Canadiens and the Stanley Cup, setting a friendly tone for the conversation. David is asked to introduce himself and his company, leading into a discussion about the tech series featuring Latinos and clinical research.
📚 Understanding the Trial Master File
The conversation shifts to discussing the trial master file (TMF), with David explaining it as the story of everything that unfolds during a clinical trial, which the sponsor is responsible for. He highlights the importance of having a TMF that can be easily retrieved and managed, especially as clinical programs grow and span across different geographies. David also touches on the challenges faced by smaller biotech and CROs in maintaining a TMF, including the transition from paper-based operations to digital systems and the need for electronic signature solutions that comply with regulatory standards.
🌐 Montrium's Global Reach and Client Pain Points
David discusses Montrium's global reach, mentioning that they primarily work with sponsors in the US and Europe. He identifies the main clients as small to mid-sized biotech companies that require core tools for collaboration and document management. David outlines the main pain points for these clients, such as the challenges of electronically signing and approving documents in a compliant manner, the outsourcing model and sponsor-CRO collaboration, and the need for better oversight and inspection readiness. He also talks about the potential of AI and machine learning in the future of TMF management and the importance of standardization and education in the industry.
🚀 Future of TMF and Closing Remarks
The discussion concludes with the host and David exploring the future of trial master files, focusing on the potential applications of AI and machine learning in document classification and file structure maintenance. David emphasizes the need for better standardization and adherence to best practices, such as the TMF-DIA reference model. The host thanks David for his insights and encourages viewers to learn more about his company and stay updated on the tech series. The video ends with a call to action for viewers to follow David on LinkedIn and subscribe to the email list for the clinical research series.
Mindmap
Keywords
💡Montrium
💡Trial Master File (TMF)
💡Clinical Research
💡Life Sciences
💡Account Executive
💡Regulatory Compliance
💡Sponsors
💡CRO (Contract Research Organization)
💡AI and Machine Learning
💡Standardization
Highlights
David Kovac introduces himself as an account executive on the sales team with Montrium, a life sciences tech company.
Montrium focuses on providing smaller sponsors and CROs with core tools to manage their trial master file and regulated content affordably and scalable.
A trial master file (TMF) is described as the story of everything that unfolds during a clinical trial, which the sponsor is responsible for.
Many sponsors and CROs are still paper-based in their operations, leading to challenges in managing the TMF system.
The growth of clinical programs and geographical expansion increases the complexity of managing TMFs.
TMF includes all documents related to clinical research processes, except for source documents and patient data.
David's background in sales and retail technology led him to Montrium, showing a non-traditional career path into the clinical research world.
Montrium works primarily with sponsors in the US and Europe, focusing on smaller biotech companies.
Challenges faced by clients include electronic document approval in a 21 CFR Part 11 compliant way and sponsor-CRO collaboration.
The outsourcing model is prevalent, with many sponsors inviting their CROs to work within their systems for better oversight.
AI and machine learning are emerging as tools to help classify documents automatically and maintain file structure within TMFs.
Standardization and education on best practices for TMF management are expected to improve in the coming years.
The importance of being educated and informed about the growing area of research and TMFs is emphasized.
David's organization, Montrium, aims to change the game in how clinical research is conducted and enable better collaboration between sponsors and CROs.
The future of TMFs may involve better standardization and the application of AI and machine learning to streamline processes and improve oversight.
Small biotech companies are seen as the new big, offering opportunities for growth and innovation in the clinical research space.
Transcripts
hey guru nation welcome back to another
episode
i've i'm here um at one of the offices
working or at least pretending to work
uh but i've got david from all the way
from montreal you can tell by the
montreal canadiens
i'm very proud of this for those
watching in the future maybe they won
the stanley cup or maybe they lost we
don't know because that's the future
um not a good way to get this started
down
all right let's hope they're gonna win
who are they playing
tampa bay lightning oh yeah i have no
dog in the fight let's go montreal let's
go montreal
oh i'm rooting with you david okay so
david why don't you introduce yourself
the company you work for we're going to
try to get you featured on
latinos and clinical research on the
tech series
um why don't you tell us a little bit
about
what you do and then we'll get into your
background how you get started in
research and all that kind of stuff
yeah awesome thanks dan so uh my name is
david kovac i
uh i'm an account executive on the sales
team with montrium
we are a life sciences tech company
and we are laser focused on providing
smaller sponsors and cross with
the core tools that they need to manage
their trial master file their
all their all their regulated content
really
in a way that's affordable and scalable
as as they grow
i get this question a lot i want to
focus more on your background
but i get this question a lot from
people hey
i have a job interview what is a trial
master file
have you developed like an easy way to
explain this
uh that's a great question so the trial
master file we like to say is really
the story of everything that unfolds uh
during the clinical trial which the
sponsor is of course
uh responsible for whenever a regulator
an auditor comes knocking
how how's that that's a very i like that
answer a lot
story of the trial story
of a truck chris wants to hear he's
gonna have to watch it right
yeah it's involves storytelling
but i like that because that's memorable
and uh
i think it's a good way to explain it
now for those
who don't know
just how time-consuming this is
because chris and i i have the
headphones and he can't hear you but
chris and i
were talking uh to another sponsor or
like a smaller
like investigator initiated sponsored
today i took this question just
yesterday on
was a trial master right right so they
they have no idea
and i'm wearing the headphones because i
don't want the echo from from david's
computer but
the like these some of these there's
people who have no idea
the amount of work that goes into
maintaining
a tmf drum master file system can you
give us just
some examples of the nightmare that that
is to manage this
so you would be shocked dan and chris at
how many sponsors and and you know on
the biotech side on the cro side
who are still paper based in in their
operations and
so i'm talking like wedding paper
signatures
uh having things in binders and stacks
of paper
and you know maybe for a phase one study
with a handful of
patients it's manageable but you know as
your clinical programs grow
it really becomes and as they grow you
know through different geographies we're
talking about sites in different
states or countries it just it it
becomes unmanageable and so
when you think about the thousands of
thousands of documents that you need
that you're responsible for keeping
uh you know ideally in the in a specific
format
in a way where you can easily retrieve
documents
yeah it's just it becomes very very
overwhelming and so
i think about my idea like what kind of
documents like we're talking everything
right
yeah monitoring fizzer reports 1572s
medical licenses for your pis every
single part of the protocol
uh that every action that takes place in
clinical research
if it's not documented it didn't happen
right basically everything except
a source document that's being exactly
no patient data
uh it's the outcomes of all the clinical
processes throughout the study i would
say i like that follow-up letters
confirmation letters all that stuff so
to learn more about david's
company and organization tune into
latinos and clinical research because
we're going to feature them
do a demo we're going to go in depth on
this stuff but i wanted to get into
a little bit as we wrap up here your
background
how does one how does a guy from
montreal even
land into this world of trial master
files
great question so i uh so i work in
sales so i didn't really have the
traditional
career path maybe like the science
background that a lot of your
listeners maybe have but
um i i just follow my what i'm
passionate about and so
i come from a sale working in sales that
a retail technology background
i was really interested in that for a
few years and then this opportunity came
up with
uh montrium you know a local smaller
vendor
changing the game in terms of how
clinical research is
is done and you know enabling sponsors
and
cross to collaborate better uh and i
just jumped at the opportunity because
uh i had very little experience i
started my career working
uh with an internship actually at
novartis i worked in their
ophthalmology business unit yeah
guys chris was asking a good question i
should ask you
um yeah do you guys work primarily with
canadian sites or us sites or just
anywhere in the world so we uh
work primarily with not so much
sightstand but
really sponsors no sponsors sorry yeah
that's okay
mostly uh in the us uh as half our
businesses
is in the us and the other half is is in
europe mostly in the us
and so that's a it's a
what are what are the main pain points
of these clients that come to you
the pharma the cross the biotechs first
of all who is your main
client like what time is it a cro a
small biotech or a big pharma
it's really the the small biotech and
when i say small i mean
the 10 to around 250 500 person biotech
who really like i said needs a lot of
these core tools
just to collaborate the same tools that
we use in our everyday lives like google
drive
they need that you know people expect
that ease of use
in how they're collaborating on these
documents so
um what are some of the what are some of
the challenges i mean
look signing off on documents approving
documents
electronically in a 21cfr part 11
compliant way is seems basic to to you
and i but
it's a challenge for people if they
don't have a docusign or an adobe sign
right that's validated so that's that's
a challenge
we've seen a lot of people move towards
these types of tools
especially in the last year and a half
the other thing i would say
is sponsor cro collaboration so
the outsourcing model is is alive and
well i don't have to tell you
but how like how unless you have the
the most uh unless you're working with
dan crow
who is very proactive at you know
sending you your reports and keeping you
up to date with
what's happening in the tmf there's
there's a lack there's still
a pretty big gap in terms of oversight
and so
we've seen a lot of sponsors actually uh
you know put an etmf in place at their
company and then invite their cro
to work within their system so it really
gives the sponsor that added level of
oversight
and the ability to be proactive in
communicating with the cro hey what's
going on i see that
you know such and such document is is
overdue
and so a lot more it elevates inspection
readiness it elevates
your the oversight that the sponsor has
so that's another
issue that we've seen uh and
is definitely easier said than done but
it's perfect
i love the small biotech small as the
new big
this is why chris and i and few others
on the clinical research
circle analyze some of these small cap
biotechs because
first of all they're interesting second
of all the stock moves a lot based on
different catalysts
and events and then lastly that's where
like the opportunities are for
guru nation for people watching even for
david
and his organization so what is what do
you think the future holds for tmf
for companies like yours that's a great
question
um so a really hot topic that we're
seeing come up
is in many different industries is how
does
ai and machine learning apply to
clinical research in the trial master
file
and we're starting to see whisperings of
helping to classify documents
automatically
helping just maintain your file
structure
so i mean we're seeing just the
points of field which is not easy when
you look at the regulatory
side of things um so that's i i would
say is
one thing to look out for the other is
just better standardization
so we have the tmf dia reference model
to go by
how many organizations out there are
following that
reference model are are prepared
you know when the spot when an auditor
comes knocking so
i would say that you know elevating the
standardization and educating people
as to these best practices is something
that's going to
improve a lot over the next few years
love it love the answers david
to learn more about david and his
organization
tune in to latinos and clinical research
youtube channel
and subscribe to the email list so you
don't miss out on the live tech series
i appreciate it david i'm sure we've
helped a few people out with the
questions on tmfs and
just made a made this topic a little
more interesting for people
uh because it's a growing area of
research and we gotta be educated we
gotta be informed
so thank you david i appreciate it and
thank you everybody for watching
listening links to david's linkedin
underneath the video
and in the show notes take care
everybody bye bye
関連動画をさらに表示
eTMF Systems Introduction
What is a Trial Master File (TMF) Specialist?
TMF Reference Model Training Part 2
How CROs and Sponsors Improve TMF Management with a Shared eTMF - Agatha eTMF software
TMF Reference Model Training Part 1
"Unlocking Business Success: Keith Newman & Brian Smith Share Key Strategies
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