How CROs and Sponsors Improve TMF Management with a Shared eTMF - Agatha eTMF software
Summary
TLDRIn this insightful webinar, industry experts Barb, Ken, and Carrie delve into the evolving role of Technology in Clinical Operations (TiCO) and its impact on Trial Master File (TMF) management. They discuss the critical relationship between stakeholders, the technological advancements in eTMF systems, and the importance of collaboration and transparency. The webinar also explores the challenges and future trends in TMF management, emphasizing the need for a more integrated and automated approach to enhance efficiency and regulatory compliance in clinical trials.
Takeaways
- đ€ Strong collaboration and mutual respect between sponsors and CROs are crucial for successful clinical trials.
- đ Clear expectations and roles from the outset can significantly improve the efficiency of trial management.
- đ» Embracing technology like electronic Trial Master Files (eTMFs) can streamline processes and enhance communication among stakeholders.
- đ Transparency in the TMF is essential, with regulators like the FDA expecting the TMF to tell the full story of a clinical trial.
- đ The TMF should not be seen as merely a storage space but as a dynamic tool for collaboration and process management.
- đ The future of TMFs involves integration with other systems and platforms for seamless data exchange and remote monitoring capabilities.
- đ Regular audits and quality checks of the TMF by all parties ensure regulatory compliance and maintain trial integrity.
- đ ïž Challenges in past collaborations can provide valuable lessons for improving future partnerships and working relationships.
- đ Adopting a digitized approach for clinical trials can significantly improve data management and regulatory compliance.
- đŻ 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
đ€ 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.
đ€ 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.
đ 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.
đ 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.
đ 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.
đ€ 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.
đ Additional Resources and Closing Remarks
Barb and Ken wrap up the webinar by informing the audience about available resources, including a white paper co-authored by the panelists and a forthcoming webinar on the technology adoption curve. Ken extends an invitation to participate in a research project aimed at understanding and improving technology adoption in clinical trials. The session concludes with thanks and appreciation for the audience's participation and engagement.
Mindmap
Keywords
đĄClinical Trials
đĄSponsors
đĄCROs (Contract Research Organizations)
đĄTMF (Trial Master File)
đĄTechnology
đĄCollaboration
đĄRegulatory Compliance
đĄElectronic Documents
đĄDashboards
đĄRemote Monitoring
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
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