August 11, 2025 • 30 mins
In this episode, host Etienne Nichols speaks with Greenlight Guru's Christine Wilbert, an expert in Electronic Data Capture (EDC) systems for Clinical Research Organizations (CROs). They discuss the critical factors CROs must consider when selecting an EDC solution. Christine highlights that the biggest mistake is a lack of due diligence and not planning for future needs beyond a single study. She emphasizes the importance of looking for a solution that can scale with a company's growth, from pilot studies to pivotal trials, and warns against hidden costs and inadequate post-sales support.
The conversation delves into what truly matters in an EDC platform, such as intuitive design, speed of implementation, and the ability to handle repeatable processes. Christine shares that while some vendors may offer "bells and whistles," the core value lies in a lean, efficient system tailored to medical device trials. They also touch on the importance of involving all stakeholders, including site users like clinicians and healthcare professionals, to ensure system adoption and maintain data integrity.
Finally, the discussion explores how an EDC system can help CROs win more business. Christine explains that having a scalable, pre-validated solution and a vendor that actively supports business development can be a significant advantage. They also cover the essential compliance features for global trials, such as FDA 21 CFR Part 11 and ISO 14155, and the growing role of hybrid and decentralized trials. Christine's final advice to CROs is to "do your due diligence" and select a solution that's a true partner for long-term success.
Key Timestamps
- 00:02:39 - Biggest mistakes CROs make when choosing an EDC.
- 00:03:00 - The importance of future planning and scalability.
- 00:04:40 - The value of post-sales support and avoiding hidden fees.
- 00:05:31 - Essential features versus "vendor noise" and unnecessary bells and whistles.
- 00:08:11 - The analogy of a "battleship" vs. a "ninja" in problem-solving.
- 00:09:13 - Identifying key stakeholders for successful EDC implementation.
- 00:11:17 - Challenges and strategies for engaging healthcare professionals.
- 00:13:31 - When to start looking for an EDC solution and the typical timeline.
- 00:15:44 - The onboarding process and what successful companies do in the first few months.
- 00:18:39 - How CROs can use an EDC solution to win more business.
- 00:20:52 - Global compliance considerations (FDA, EU MDR) for EDC platforms.
- 00:23:36 - Features CROs think they need but don't (e.g., QMS integration).
- 00:26:03 - Adapting to hybrid and decentralized trials.
- 00:27:22 - The key takeaway: do your due diligence and seek a true partner.
Quotes
"I would say the biggest issue is lack of due diligence... they're not necessarily thinking down the line, 'how is this going to scale with this specific company that they're working with?'"
"The bitterness of poor quality remains long after the sweetness of low price is forgotten."
Takeaways
- Prioritize Scalability and Long-Term Planning: Don't choose an EDC solution just for a single pilot study. Evaluate whether the platform can handle the complexity and size of pivotal and post-market studies to avoid costly transitions in the future.
- Look for True Partnership, Not Just a Vendor: A successful relationship with an EDC provider goes beyond the initial sale. Seek a vendor with strong post-sales support and a willingness to collaborate on...
Mark as Played
Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
(00:00):
Welcome to the Global MedicalDevice Podcast where today's brightest
minds in the medical deviceindustry go to get their most useful
and actionable insiderknowledge direct from some of the
world's leading medical deviceexperts and companies.
(00:31):
Hey everyone.
Welcome back to the GlobalMedical Device Podcast.
My name is Etienne Nichols.
I'm the host for today'sepisode and with me today to talk
about clinical solutions andelectronic data capture.
And when you're choosing oneof those solutions, what do you need
to be thinking about?
So I'm calling this episodekey considerations for Clinical Research
Organizations.
(00:52):
If you've actually been payingattention to this subject or this,
this sentence, it's anincredibly run long run on sentence
because I was supposed to beintroducing someone right now.
But with me today to talkabout those key considerations for
clinical researchorganizations is Christine Wilbert.
She is an experienced accountexecutive at Greenlight Guru specializing
in edc, which is electronicdata capture systems for clinical
(01:14):
research organizations,sometimes called CROs.
With over three years, wellaround three years of hands on experience
selling to these differentorganizations and implementing EDC
solutions, Christine'sdeveloped a sharp understanding of
the unique needs and decisionmaking challenges CROs face in today's
future fast evolving clinical landscape.
Her background in businessdevelopment and clinical operations
(01:35):
across North America gives hera well rounded perspective on how
CROs can select, scale andsucceed with modern digital tools.
And I say North America, butshe's really been all over the world
selling these things.
I was going to say, I wasgoing to say I feel like majority
of our customers are kind ofEuropean at this point in time.
Global, but absolutely NorthAmerican, a wide array.
(01:56):
But great to be here, thanksfor having me.
So glad to have you.
And one of the reasons I wasso excited to have you on at the
end and just those of youlistening, I sort of tricked Christine
to, I don't know if sheactually knew we were going to be
recording a podcast today, soapologies for that sort of sorry,
not sorry, but she's always.
So you typically have anopinion and whether it's right or
(02:18):
wrong, I, I'm a believer instrong opinions held loosely.
So those of you listening, Ihope you enjoy this episode.
Absolutely.
Okay, if we were to talk aboutclinical research organizations and
maybe they're looking for anelectronic data capture system, what
do you think the biggestmistake those CROs make and how do
you stop that before it happens?
(02:39):
Absolutely.
So in my experience I wouldsay the biggest issue is lack of
due diligence, lack of duediligence of the software and, but
also not future planning.
So they're looking for asolution for one particular study.
They're not necessarilythinking down the line, how is this
going to scale with thisspecific company that they're working
(03:02):
with?
So if they're just working nowon a pilot study of this organization,
how is that going to look downthe line when they move to that pivotal
study?
Is this platform going to beable to support that?
So I'd say that's one of thebiggest areas.
Also choosing a solutionwithout necessarily understanding
the cost is one thing, but asyou get down the line, is there going
(03:23):
to be additional costs for amendments?
Are there going to be thesehidden fees for support?
Is there going to be thatlevel of support?
So time and time again we seeit with, with partners that we've
worked at that are coming fromother vendors and they finding that
there's these hidden coststhat if you, hey, if you have amendments
for a large study, that addsup very, very quickly.
(03:44):
But also there's supportneeded and there's a lot of solutions
out there that are great.
But it's kind of one of thosethings where the work is done.
What is that?
After sales support,especially if you're looking at a
solution that focuses onpharmaceutical, that's probably going
to be the primary place thatthose companies are supporting the
pharmaceutical studies.
(04:04):
Med device probably not goingto be their priority.
So another aspect, greenlight.
What we constantly are hearingfrom customers is our support throughout
the sale process.
But once they're signed andpartners with us, that after sales
support is something thatwe're constantly getting praised
on and it's one of our biggestvalue adds for teams.
Yeah, and I don't even so me,I'm a poor ignorant fellow over here.
(04:28):
I just do podcasts and talk topeople about different things.
I don't even know about thepricing structure of any of these
things.
But when you were talkingabout thinking and beginning with
the end in mind andconsidering the cost down the road,
it makes me think of thatphrase from Benjamin Franklin.
The bitter bitterness of poorquality remains long after the sweetness
of low price is forgotten.
And so whether we, I don'teven know how we compare and we don't
(04:51):
have to get into thatnecessarily today, but I do think
that's a really valuable pointthat you make.
So when, when those CROs areevaluating those EDC platforms, you
kind of mentioned severalthings there.
Are there things that you feellike are just, I don't know, vendor
noise or just things thatpeople want to throw at them, just
different?
(05:11):
I mean, if we were to look atthis from how could we help the vendors
out?
Like you know what this, thisand this really doesn't matter when
it comes down to running your trial.
That's those are the bells andwhistles that nobody uses.
I mean there's always bellsand whistles nobody uses, but anything
that you feel like it's justkind of noise and the it doesn't
have to be featured.
I have to be anything like that.
But anything come to mind.
I mean the key aspects thatwe're we're getting and what we're
(05:37):
focusing on time and timeagain is an intuitive design of solution.
We obviously want this processto be as seamless as possible for
teams.
Whether it's the CRO orwhether it's the sponsor, the manufacturer
that's building the study, wewant it to be a seamless process
for them.
One aspect we do that it's ano code solution with greenlight
which definitely helps that process.
(05:58):
But again with us beingmedical device specific and medical
device focused, the nature ofour platform is very intuitive.
It allows for repeatable processes.
So companies specificallycontract research organizations,
as you can imagine imagine,are managing tens to hundreds of
studies at a time.
Having this repeatable processand being able to scale quickly and
(06:19):
efficiently with an intuitivesystem is key.
When you're talking aboutspeed to implementation.
The difference of standing upa system in a few weeks versus six
months, as some of the more sogeneric pharma focused EDCs allow,
I.e.
huge for companiesspecifically in startup where budgets
are low, they don't have thattime to wait around for a study to
(06:42):
start.
So that's another aspect wheregreenlight really comes in.
Speed, intuitive design,repeatable processes.
So beyond that I'd say itemssuch as just real time visibility,
obviously having a prevalidated solution that also plays
into the speed for teams wantto double tap on the importance of
(07:02):
having vendor that has a goodsupport throughout the sale and after
the sale as well.
So I'd say those are kind ofthe most important aspects that really
matter from a vendor noise more.
So I'd say if you're workingon one of the working with the generic
pharma focused solutions,they're going to have more bells
and whistles.
But that's one of the kind ofvalue adds we say for our med device
(07:26):
specific solution is we'remore of a lean solution.
We have all thefunctionalities that a company needs
for med device trial.
That to be said, we do havepharmaceutical companies that are
using our system.
So it's not that we can justdo Med device, but it's more so it's
tailored to their needs already.
(07:46):
So I'd say from like agreenlight perspective, we don't
really have those features,functionalities that aren't necessary
and we're not really, Iwouldn't say there's noise on that
side, but you do have teamsthat are coming to us that are asking
for specific dashboards.
And dashboards are nice to have.
I mean, we have some out ofthe box ones and we can build anything
(08:06):
with Microsoft Power bi.
But those are more nice tohaves for the most part than a need
to have.
Yeah.
You know, it's funny, when Iwent to school, I went to school
for mechanical engineering andsomeone told me once like, oh, that
really probably helps yousolve a lot of problems.
And it does, it really does.
But at the same time, if Ihave a problem I want to solve, it's
kind of like I've been trained.
(08:27):
Like previously I was a ninjaand they've turned me into something
of a battleship.
And so I say, okay, there's alittle problem, let's turn the battleship
and we're going to go downinto the physical level.
Sometimes you think, you knowwhat, all we really need is a ninja
right now.
And so maybe that's not applicable.
But sometimes I think aboutthat like, oh man, what have we done
to ourselves?
When, when you're talking todifferent teams, I'm curious.
(08:54):
You've probably seen, I mean,you've been here long enough now
and, and sold enough, enoughseats at the table or clinical trials
and et cetera.
I don't know what the rightterminology here is.
When you, you, you seesomebody really succeeding with their
clinical trials who wasinvolved in the thought process from
the very beginning.
Yeah, I mean, it depends onthe size, type of organization that
(09:18):
we're working with.
Obviously you want someone inthe clinical operations side of things,
someone that sees this day in,day out.
But data managers are key tothis process.
They are the ones that arefamiliar with the EDC systems.
They know what's needed fromthe site level as well, project managers.
So really anyone that'sinvolved in the day to day, obviously
(09:39):
you want the key decisionmakers involved in that process.
Typically they're coming inmore so later in that stage and really
they're trusting theirclinical operations team to make
that decision.
I'd say folks that are leftout often are the site users.
And I realize it's difficultto get everybody into these meetings,
(10:00):
but one of the aspects that wesee from teams, not greenlight because
of Course, our system'sintuitive, but is site staff not
adopting the platform?
And at the end of the day,your EDC is only as good as the data
being entered there.
So if you have some site folksthat are entering data and others
are doing it on paper, then itcan end up being a bit of a mess
(10:21):
and a little convoluted to tryand piece things together.
And that's just not super efficient.
So having those folks involvedearly on is somewhat helpful.
And that doesn't mean theyhave to come join the call, but we
can share recordings withthem, making sure that they have
an understanding of the system.
Now, every solution or everyvendor should do this, but we do
(10:42):
provide site training.
You want to make sure that allthe site staff are up to speed and
with greenlight, it's nice.
It takes about 30 minutes forthe site staff to get trained on
the software.
So again, intuitive,simplistic for them to use.
But I'd say site users areprobably one of the ones that we'd
see.
So the site users, justbecause I'm not as, I guess, savvy
with clinical investigationsand so on, is we're talking about
(11:05):
healthcare professionals,typically, is that accurate?
Yeah, it can be healthcareprofessionals, clinicians.
So folks that are actually atthe physical locations entering the
data into the system.
Yeah.
And it's interesting, there'sa lot of talk in the software world
about how do you.
How to really break into thehealthcare professional world or
(11:26):
their, I don't know, their workflows.
I don't know if you have anysuggestions on how to.
Actually, I don't.
I hate to say this, butdoctors are so busy.
The ad, the administrativeburden is just so hard right now.
It's almost like you got toget them and just look me in the
eye for a second.
How do you actually get theirattention and kind of implement into
(11:47):
their workflow?
Any thoughts or suggestions there?
I mean, so that's.
We didn't really speak aboutdoctors in the last one, but there's
a lot of physicians that areinvolved in our conversations.
Typically there's eithersurgeons or they're lead physicians
that are involved.
As difficult as physicians canbe, sometimes they seem to quite
understand the importance ofthis process and that's definitely
(12:10):
not, not all of them.
We still have the ones thatare the.
They want to do this on paper,they're going to do things the old
school way, but I haven't seena ton of resistance.
Honestly, some of my, I don'twant to pick favorites, but some
of my favorite prospects.
Favorite Customers arephysicians and they understand the
value of an EDC system andthey know that if you want to capt
(12:34):
clean data and do it in themost efficient way, this is what
you have to do.
Yeah, and I want to justclarify something I said because
some of my, the most, myfavorite people to talk to actually
are physicians as well.
Because I mean they're on thefront lines.
They're actually the ones whoknow the problems that we're trying
to solve.
So no, I have so much respectfor them and I wish the administrative
(12:54):
burden was not so high.
But anyway, yeah, the wholenother topic there.
So when, when you're buildingout a clinical trial or I guess you're
getting most likely by thetime that teams come to you, they
have a lot of different thingsthat they have in mind.
At what point does it actuallymake sense to start reaching out
(13:15):
and, and looking intosolutions like this?
And because once they get inmy mind what I'm, if I'm a project
manager, I'm thinking, okay,we got a clinical investigation coming
up, it's time to start gettingready for that.
How much time does it take toget these things set up?
What's the, how do you balance that?
Yeah, I mean with.
It varies obviously vendor to vendor.
Some solutions you can have 12month implementations for them and
(13:41):
it obviously depends on the space.
Obviously pharmaceutical aregoing to be longer in that nature.
With Greenlight, I'd say thesweet spot is really three to six
months for teams to come to us.
Obviously coming to us alreadyhaving the study protocol put together
or almost complete ready forsubmission, having their case report
forms or patient reportedoutcomes already developed, super
(14:04):
helpful.
Those are the favorite peoplewe have that like, ah, we love this.
But really at the stage wherethey're focused on that decision
making, focus on evaluatingwhat EDC is going to be the best
move.
If they're working with a CROat that point in time, probably a
conversation that they shouldhave sooner than the EDC because
(14:24):
that process can take a bit.
But that being said, we alsoare bringing in our CRO partners
into conversations and they'reable to work relatively quick.
I think it was just yesterdayactually we have working with a customer
that is starting a study inOctober and they're just starting
to select CROs now.
So getting everything moving quickly.
But again with Greenlightbeing med device focused, our implementation
(14:48):
time frame and speed to gettheir studies stood up in the system
and ready to go live issignificantly quicker than a lot
of solutions out there.
Typically we tell teams fourto six Weeks from contract in place
to ready to go live.
We've stood up studies in aweek before.
We don't recommend that.
We want to give team sometime, a little bit of grace in the
(15:10):
back end, but it can be done.
So yeah, but three to sixmonths, I'd say that's a great timeframe.
As far as planning goes.
It gives you some leeway.
Obviously teams want to dotheir due diligence and look at the
solutions to find somethingthat makes most sense for their needs.
But typically for us that's agreat timeframe.
Okay, so we won't.
I'll try not to repeat the oneweek thing because someone's probably
(15:32):
gonna get onto yours at some point.
But okay, so three to sixmonths, what does that actually look
like?
If you're.
You said from signed contractto studies stood up, what are the
really successful companiesdoing in those three to six months?
Yeah, so I mean, obviouslyfrom my perspective, I'm talking
to them very early on.
So having that initial, justunderstanding of what the scope of
(15:53):
their study is, what is theirtimeframe, really doing that initial
discovery phase and kind ofgiving them that background.
If they're already familiarwith Greenlight and who we are, we're
having that conversation.
Beyond that, obviously we wantto show technical fit.
So we're walking them througha demonstration.
We like to loop in as many ofthe stakeholders, folks that are
going to be involved that wepreviously discussed.
(16:14):
So any of those data managers,clinical operations folks, having
them involved in thatconversation so that they can see
from both the build aspect andmaking sure anyone that's going to
be involved in that process,okay, this is intuitive.
We've got this.
We can easily stand this up ourselves.
And then from the monitoringperspective, when we're looking at
data capture, is this going tobe something that the sites will
(16:35):
easily adopt?
Obviously beyond that there'sother features, functionalities.
We want to be able to showwhat the reporting capabilities,
export functionalities are.
But really you're just tryingto make sure that everything that
they need for this specificstudy and future studies is all encompassing
in our solution and we'll beable to scale with them.
So we're having that conversation.
(16:55):
Obviously then you might haveanother one and bring other stakeholders
into that conversation.
But really we're just tryingto determine technical fit and then
align to their time, timeframe.
So we're kind of workingbackwards in that process.
Once we're determining technofit cost, obviously going through
that aspect, we're contract inplace, bringing in our customer success
team.
(17:15):
So introducing them to whothey're going to be working with
throughout the entirety of the partnership.
So from myself, handing off toour customer success team, then we're
going through this process ofonboarding the team.
And now if they're planning onbuilding, we're going to help them
understand the platform andreally set them up for success in
(17:36):
getting that study built inthe system.
If their team is choosing tobuild it, we'll obviously support
them in that, do a little bitof hand holding and make sure they're
ready to go.
Another service obviously thatwe provide is study builds and validation.
So for teams that don't havecapacity or don't have that experience,
that's something Greenlightcan also take on.
So that's kind of a little bitof that process.
But inevitably we're going tomake sure that their study is set
(17:58):
up in the system, everythingis validated, working the way that
it's meant to, inevitablygetting them ready for steady kickoff.
So that's kind of what'shappening in that three to six month
period.
So the way Greenlight grew,clinical is set up or the way it's
been built, designed,whatever, a medical device company
could purchase this solution,just keep their own just instance
(18:19):
of the software and run theirtrials, or you can use the clinical
research organization, takeadvantage of their network and so
on.
So let's just focus on thatfor just a moment.
So a Croat if we, if we talkabout a CRO purchasing a software
platform and I can almostimagine them having multiple, I don't
know if that's accurate or notor what.
(18:39):
That is very accurateoftentimes and we see both.
But especially you can imaginewith some of the larger CROs out
there, they're working withtens, hundreds of companies and they
probably have three to fiveEDC vendors that they're working
with because it's not a onesize fits all.
So they want to be able tohave that optionality and make sure
that they're finding asolution that's the right fit for
(19:00):
their company or their client.
So what I'm curious about withthose CROs and they've chosen, let's
say they've taken onGreenlight, Guru, Clinical, are there
any things about it that canhelp them win more sponsor business
by using this CDC versus that one?
Any thoughts there?
Absolutely.
So when it comes to anysolution, obviously going back to
(19:21):
having something that'sscalable and being able to repeat
processes, having a prevalidated solution that they don't
have to validate for eachtime, each instance, those things
all go into play there whenwe're talking about winning more
business.
So really the scalability ofthe platform, but then also selecting
a vendor that supports thosebusiness development activities.
(19:44):
So we partner with CROs and weactually support them on business
development initiatives to winmore business together.
Now that can be marketinginitiatives that we run together.
We can support them withoutreach activities on specific sponsors
that they're potentiallybidding on.
So really we work with ourpartners in, in different ways, but
(20:06):
at the end of the day, we wantit to be beneficial for both the
CRO and the EDC vendors.
So definitely having vendorpartner that supports those activities.
Yeah, that makes sense.
And I don't want to tootGreenlight Guru's horn too loud,
I guess, because I, I wantthis to be applicable to any.
Whatever you choose.
You know, you can use this.
You need things to thinkabout, key considerations.
(20:27):
But a vendor like Greenlightgrew with over a thousand customers,
surely there's somebody outthere who could, you know, need your
help.
So that's, that's kind ofsomething to think about.
What about CROs that aresupporting both FDA and EMDR trials?
Maybe even Latin America, allover the world.
We kind of mentioned that atthe very beginning.
How do those EDC platformsstay compliant without making, you
(20:49):
know, extra work for the sponsors?
Absolutely.
I mean, looking for a platformthat is built in validation for both
frameworks.
So FDA 21 CFR part 11 for Esignatures, audit trails, user authentication,
then ISO 14155 aligned with EU MDR.
Those are kind of the keythings I'd say beyond that, just
(21:13):
having standardized compliancestudy templates that can be utilized
across the board and alignedwith GCP.
Again, ISO 14155 study levelconfiguration and custom development.
So just having thosepredefined configurations that lay
out the groundwork for eitherFDA or eumr.
(21:36):
Again, it's something that we,I don't say we get asked it very
frequently.
I think that's just becausecompanies come to us knowing that
we are global at this point in time.
And it's just so common for usto be working with teams that have
studies that are global.
And we're so upfront about thefact that we work globally and we
(21:59):
do, we are compliant with bothEU MDR and we provide all of the
documentation for teams in advance.
So I think the Green LightGuru name itself and just our presence
helps to kind of get messagingout there before we have the conversation
or before I get to the conversation.
Right.
(22:19):
Yeah, there's, it'sinteresting when I think about that
we put the guardrails in place.
That's always been the goal.
And sometimes when I talk tonew prospects about the greenlight
guru, say, let's say qualitymanagement system with the change
control, we have a built inperformance evaluation or evaluation,
I guess it always has thatword perform that throws me.
But there's an evaluation thatyou have to go through.
(22:41):
If you're going to change thedocument, it's going to ask you did
you change, did you change the product?
If you did, did you change the design?
Or, or do you need to gothrough design validation, do you
need to go through design verification?
And maybe I should stop sayingthis but it makes this free text
form and it forces you toanswer the question.
And I typically tell them nowlisten, we can't make, make your,
make sure your engineersaren't lying.
(23:01):
We can't make them tell the truth.
You could still do that if youwanted to, but we at least force
you to ask the question.
So when you put thoseguardrails in place, I don't know
if you've ever bowled with afive year old.
I have a five year old wholikes to go bowling and they put
the bumper up.
He can still get it in theother lane, that kid, you know.
So anyway, bumpers are there,you know.
But you still can't ever turnyour brain off.
Oh absolutely.
(23:22):
I want to, I want to ask you aquestion then because you probably
get asked all kinds of thingsduring the sales process.
Are there any features thatCROs think they need in an EDC but
really they don't.
I mean it, it's also dependenton the study.
Again, this might besomething, if I'm being honest, we
(23:46):
don't really come across.
I'm going to go back to thatprevious response of dashboards.
It's more so just wanting tounderstand like what capabilities
do you have regardless if weneed it or not for this study, they
just want to know.
Oftentimes it's.
Is your EDC integrated withyour quality management system?
That's probably the thing thatI get asked the most.
And then when you put it backon them and ask why they would want
(24:09):
that, they have no idea.
It's just, it feels like theyshould speak to each other when in
fact there is no reason foryour, your EDC system to speak to
your quality management systemand have any interaction there.
I'd say that's probably thething that I get asked most.
But beyond that, again, ushaving a solution built for med device,
we really have all thefunctionalities that would be needed
(24:32):
for any of these studies fromthose early development first in
human through your pivotal andpost market follow up studies.
It's lean but also heavyenough functionalities to ensure
that we have everything thatthese teams need.
I don't think that reallyanswers your question, but I don't
spend a lot on the featureheavy questions.
(24:53):
No, that's okay.
I guess I don't know what mademe think of that, but my wife really
wants a new Ford Expeditionand one of the features she wants
is the back massage thingbecause her friend has a, a version
of that and she sat in thereand she tried the, the back massage
and she's like this is amazing.
So I asked her for him likehow, how often have you used this
back massage?
Like, well, I used it oncewhen I first got it.
(25:15):
I've forgotten about it.
It's been years now.
I'm like well okay, so shouldwe go ahead and spend the extra several
thousand?
I don't know, I mean I wouldprobably use it.
But anyway, if he's thepassenger and you're on a long haul
trip, for sure, 100%.
So anyway, there's alwaysthose things out there that like
oh man, that sounds amazing.
But yeah, okay.
(25:35):
So any I want to ask aboutmaybe hybrid decentralized trials
on the rise?
I wonder if you have anythoughts on how EDCs may be evolving
or how they have evolved tomeet that need.
And are there any things maybeCROs should be asking vendors that
maybe they didn't need fiveyears ago now that they do?
You know, I mean if someone,you know, maybe they've been out
(25:57):
there a while, they've.
Yeah, I'm just, just nowevaluating these things.
Any, any specific questionsyou think they should be asking?
Yeah, I mean I don't thinkthere's too many systems out there
at this point that, thatshouldn't be up to speed with that.
This is the way that the worldis going.
But you do have the, some CROsthat are smaller.
Coming from paper previously,it's still a thing.
Crazy enough, but justunderstanding how do you support
(26:21):
remote data entry?
EPro is one that's, that'shelpful to know and I know not every
Solution does offer ePro.
So for those that don't knowePro, patient reported outcomes giving
you the ability toelectronically send questionnaires
to participants.
So having that functionalityis quite nice.
Multilingual studies, I guessthat's something to look for.
(26:46):
Those I'd say are probably thebiggest things.
Remote data entry I think isprobably the biggest One for them
to ask again.
That's kind of table stakes inmy opinion, at this point in time
for a vendor to have.
Beyond that.
Yeah, I'd say the main things.
Okay, well, this has beenreally fun conversation for me, I
(27:09):
hope for you as well, eventhough I had to trick you into this.
Do you have, if you could giveone takeaway or one piece of advice
to someone who works at a CROwho's listening to this, what would
that one piece of advice be?
Ooh, I guess I'll go back tothat kind of first question of do
your due diligence.
Don't just think about theimmediate need.
(27:30):
Think long term down the line.
Is this going to be a solutionthat we can scale with and is this
going to be a true partner andthat maybe you don't want a partner,
maybe you want a vendor.
But we'll say if it comes downto it and you're looking for a long
haul and you want your team tofind a solution that they can adopt
and it's in the long run goingto save you a lot of time and money
(27:53):
from not having to train onother solutions.
Really look at the platform'scapabilities for not just the study
ahead of you, but down the line.
And then is there somebusiness development initiatives
we can work on?
And yeah, I'd say those arethe key things.
I love the distinction betweenthe partner and the vendor because,
I mean, there are some thingsthat it makes sense to only have
(28:16):
a vendor.
Why would you ever talk to,you know, I don't know.
I've never talked to my Zoom person.
Whoever sold us the Zoominstance that we have, I don't know.
But if, if these clinicalinvestigations are your bread and
butter, the collection and,and the management of all that, it
makes total sense that youwould want just a real close relationship
with those people.
(28:36):
Especially, anything goeswrong, you can immediately get a
hold of customer service.
I, I, man, as I've gottenolder, I have learned a really valuable
customer value, customerservice in so many ways.
But yeah, so I used to be.
I'll do it myself.
No, I want someone to help me.
No one's got time.
Yeah.
Where you you headed aroundthe world?
(28:57):
Any, anywhere anytime soon?
You know, the summer is aquieter time.
I think the sales team'sgonna, we're gonna go to Indy or
Chicago or something at theend of the month.
Maybe London in the fall.
We'll see.
There's a. I hope to see you there.
If you go.
I hope to see you there.
Yeah, that'd be fun.
Any CROs out there listening?
If you're going to be there,hit us up.
We'd love to talk and love toget to know you a little bit better.
(29:21):
But until then, I guess thanksso much for coming on the show, Christine.
I'll let you get back to it.
Live your life again.
And those of you who've beenlistening, thanks so much.
We'll take care.
We'll, we'll take, we'llthanks so much for listening.
We'll see you next time.
Bye bye.
Thanks for tuning in to theGlobal Medical Device Podcast.
If you found value in today'sconversation, please take a moment
(29:42):
to rate, review and subscribeon your favorite podcast platform.
If you've got thoughts orquestions, we'd love to hear from
you.
Email us at podcastreenlight Guru.
Stay Connected.
For more insights into thefuture of medtech innovation.
And if you're ready to takeyour product development to the next
level, Visit us at www.greenlight.guru.
until next time, keepinnovating and improving the quality
(30:04):
of life.
Welcome to the Global MedicalDevice Podcast where today's brightest
minds in the medical deviceindustry go to get their most useful
and actionable insiderknowledge direct from some of the
world's leading medical deviceexperts and companies.
(00:31):
Hey everyone.
Welcome back to the GlobalMedical Device Podcast.
My name is Etienne Nichols.
I'm the host for today'sepisode and with me today to talk
about clinical solutions andelectronic data capture.
And when you're choosing oneof those solutions, what do you need
to be thinking about?
So I'm calling this episodekey considerations for Clinical Research
Organizations.
(00:52):
If you've actually been payingattention to this subject or this,
this sentence, it's anincredibly run long run on sentence
because I was supposed to beintroducing someone right now.
But with me today to talkabout those key considerations for
clinical researchorganizations is Christine Wilbert.
She is an experienced accountexecutive at Greenlight Guru specializing
in edc, which is electronicdata capture systems for clinical
(01:14):
research organizations,sometimes called CROs.
With over three years, wellaround three years of hands on experience
selling to these differentorganizations and implementing EDC
solutions, Christine'sdeveloped a sharp understanding of
the unique needs and decisionmaking challenges CROs face in today's
future fast evolving clinical landscape.
Her background in businessdevelopment and clinical operations
(01:35):
across North America gives hera well rounded perspective on how
CROs can select, scale andsucceed with modern digital tools.
And I say North America, butshe's really been all over the world
selling these things.
I was going to say, I wasgoing to say I feel like majority
of our customers are kind ofEuropean at this point in time.
Global, but absolutely NorthAmerican, a wide array.
(01:56):
But great to be here, thanksfor having me.
So glad to have you.
And one of the reasons I wasso excited to have you on at the
end and just those of youlistening, I sort of tricked Christine
to, I don't know if sheactually knew we were going to be
recording a podcast today, soapologies for that sort of sorry,
not sorry, but she's always.
So you typically have anopinion and whether it's right or
(02:18):
wrong, I, I'm a believer instrong opinions held loosely.
So those of you listening, Ihope you enjoy this episode.
Absolutely.
Okay, if we were to talk aboutclinical research organizations and
maybe they're looking for anelectronic data capture system, what
do you think the biggestmistake those CROs make and how do
you stop that before it happens?
(02:39):
Absolutely.
So in my experience I wouldsay the biggest issue is lack of
due diligence, lack of duediligence of the software and, but
also not future planning.
So they're looking for asolution for one particular study.
They're not necessarilythinking down the line, how is this
going to scale with thisspecific company that they're working
(03:02):
with?
So if they're just working nowon a pilot study of this organization,
how is that going to look downthe line when they move to that pivotal
study?
Is this platform going to beable to support that?
So I'd say that's one of thebiggest areas.
Also choosing a solutionwithout necessarily understanding
the cost is one thing, but asyou get down the line, is there going
(03:23):
to be additional costs for amendments?
Are there going to be thesehidden fees for support?
Is there going to be thatlevel of support?
So time and time again we seeit with, with partners that we've
worked at that are coming fromother vendors and they finding that
there's these hidden coststhat if you, hey, if you have amendments
for a large study, that addsup very, very quickly.
(03:44):
But also there's supportneeded and there's a lot of solutions
out there that are great.
But it's kind of one of thosethings where the work is done.
What is that?
After sales support,especially if you're looking at a
solution that focuses onpharmaceutical, that's probably going
to be the primary place thatthose companies are supporting the
pharmaceutical studies.
(04:04):
Med device probably not goingto be their priority.
So another aspect, greenlight.
What we constantly are hearingfrom customers is our support throughout
the sale process.
But once they're signed andpartners with us, that after sales
support is something thatwe're constantly getting praised
on and it's one of our biggestvalue adds for teams.
Yeah, and I don't even so me,I'm a poor ignorant fellow over here.
(04:28):
I just do podcasts and talk topeople about different things.
I don't even know about thepricing structure of any of these
things.
But when you were talkingabout thinking and beginning with
the end in mind andconsidering the cost down the road,
it makes me think of thatphrase from Benjamin Franklin.
The bitter bitterness of poorquality remains long after the sweetness
of low price is forgotten.
And so whether we, I don'teven know how we compare and we don't
(04:51):
have to get into thatnecessarily today, but I do think
that's a really valuable pointthat you make.
So when, when those CROs areevaluating those EDC platforms, you
kind of mentioned severalthings there.
Are there things that you feellike are just, I don't know, vendor
noise or just things thatpeople want to throw at them, just
different?
(05:11):
I mean, if we were to look atthis from how could we help the vendors
out?
Like you know what this, thisand this really doesn't matter when
it comes down to running your trial.
That's those are the bells andwhistles that nobody uses.
I mean there's always bellsand whistles nobody uses, but anything
that you feel like it's justkind of noise and the it doesn't
have to be featured.
I have to be anything like that.
But anything come to mind.
I mean the key aspects thatwe're we're getting and what we're
(05:37):
focusing on time and timeagain is an intuitive design of solution.
We obviously want this processto be as seamless as possible for
teams.
Whether it's the CRO orwhether it's the sponsor, the manufacturer
that's building the study, wewant it to be a seamless process
for them.
One aspect we do that it's ano code solution with greenlight
which definitely helps that process.
(05:58):
But again with us beingmedical device specific and medical
device focused, the nature ofour platform is very intuitive.
It allows for repeatable processes.
So companies specificallycontract research organizations,
as you can imagine imagine,are managing tens to hundreds of
studies at a time.
Having this repeatable processand being able to scale quickly and
(06:19):
efficiently with an intuitivesystem is key.
When you're talking aboutspeed to implementation.
The difference of standing upa system in a few weeks versus six
months, as some of the more sogeneric pharma focused EDCs allow,
I.e.
huge for companiesspecifically in startup where budgets
are low, they don't have thattime to wait around for a study to
(06:42):
start.
So that's another aspect wheregreenlight really comes in.
Speed, intuitive design,repeatable processes.
So beyond that I'd say itemssuch as just real time visibility,
obviously having a prevalidated solution that also plays
into the speed for teams wantto double tap on the importance of
(07:02):
having vendor that has a goodsupport throughout the sale and after
the sale as well.
So I'd say those are kind ofthe most important aspects that really
matter from a vendor noise more.
So I'd say if you're workingon one of the working with the generic
pharma focused solutions,they're going to have more bells
and whistles.
But that's one of the kind ofvalue adds we say for our med device
(07:26):
specific solution is we'remore of a lean solution.
We have all thefunctionalities that a company needs
for med device trial.
That to be said, we do havepharmaceutical companies that are
using our system.
So it's not that we can justdo Med device, but it's more so it's
tailored to their needs already.
(07:46):
So I'd say from like agreenlight perspective, we don't
really have those features,functionalities that aren't necessary
and we're not really, Iwouldn't say there's noise on that
side, but you do have teamsthat are coming to us that are asking
for specific dashboards.
And dashboards are nice to have.
I mean, we have some out ofthe box ones and we can build anything
(08:06):
with Microsoft Power bi.
But those are more nice tohaves for the most part than a need
to have.
Yeah.
You know, it's funny, when Iwent to school, I went to school
for mechanical engineering andsomeone told me once like, oh, that
really probably helps yousolve a lot of problems.
And it does, it really does.
But at the same time, if Ihave a problem I want to solve, it's
kind of like I've been trained.
(08:27):
Like previously I was a ninjaand they've turned me into something
of a battleship.
And so I say, okay, there's alittle problem, let's turn the battleship
and we're going to go downinto the physical level.
Sometimes you think, you knowwhat, all we really need is a ninja
right now.
And so maybe that's not applicable.
But sometimes I think aboutthat like, oh man, what have we done
to ourselves?
When, when you're talking todifferent teams, I'm curious.
(08:54):
You've probably seen, I mean,you've been here long enough now
and, and sold enough, enoughseats at the table or clinical trials
and et cetera.
I don't know what the rightterminology here is.
When you, you, you seesomebody really succeeding with their
clinical trials who wasinvolved in the thought process from
the very beginning.
Yeah, I mean, it depends onthe size, type of organization that
(09:18):
we're working with.
Obviously you want someone inthe clinical operations side of things,
someone that sees this day in,day out.
But data managers are key tothis process.
They are the ones that arefamiliar with the EDC systems.
They know what's needed fromthe site level as well, project managers.
So really anyone that'sinvolved in the day to day, obviously
(09:39):
you want the key decisionmakers involved in that process.
Typically they're coming inmore so later in that stage and really
they're trusting theirclinical operations team to make
that decision.
I'd say folks that are leftout often are the site users.
And I realize it's difficultto get everybody into these meetings,
(10:00):
but one of the aspects that wesee from teams, not greenlight because
of Course, our system'sintuitive, but is site staff not
adopting the platform?
And at the end of the day,your EDC is only as good as the data
being entered there.
So if you have some site folksthat are entering data and others
are doing it on paper, then itcan end up being a bit of a mess
(10:21):
and a little convoluted to tryand piece things together.
And that's just not super efficient.
So having those folks involvedearly on is somewhat helpful.
And that doesn't mean theyhave to come join the call, but we
can share recordings withthem, making sure that they have
an understanding of the system.
Now, every solution or everyvendor should do this, but we do
(10:42):
provide site training.
You want to make sure that allthe site staff are up to speed and
with greenlight, it's nice.
It takes about 30 minutes forthe site staff to get trained on
the software.
So again, intuitive,simplistic for them to use.
But I'd say site users areprobably one of the ones that we'd
see.
So the site users, justbecause I'm not as, I guess, savvy
with clinical investigationsand so on, is we're talking about
(11:05):
healthcare professionals,typically, is that accurate?
Yeah, it can be healthcareprofessionals, clinicians.
So folks that are actually atthe physical locations entering the
data into the system.
Yeah.
And it's interesting, there'sa lot of talk in the software world
about how do you.
How to really break into thehealthcare professional world or
(11:26):
their, I don't know, their workflows.
I don't know if you have anysuggestions on how to.
Actually, I don't.
I hate to say this, butdoctors are so busy.
The ad, the administrativeburden is just so hard right now.
It's almost like you got toget them and just look me in the
eye for a second.
How do you actually get theirattention and kind of implement into
(11:47):
their workflow?
Any thoughts or suggestions there?
I mean, so that's.
We didn't really speak aboutdoctors in the last one, but there's
a lot of physicians that areinvolved in our conversations.
Typically there's eithersurgeons or they're lead physicians
that are involved.
As difficult as physicians canbe, sometimes they seem to quite
understand the importance ofthis process and that's definitely
(12:10):
not, not all of them.
We still have the ones thatare the.
They want to do this on paper,they're going to do things the old
school way, but I haven't seena ton of resistance.
Honestly, some of my, I don'twant to pick favorites, but some
of my favorite prospects.
Favorite Customers arephysicians and they understand the
value of an EDC system andthey know that if you want to capt
(12:34):
clean data and do it in themost efficient way, this is what
you have to do.
Yeah, and I want to justclarify something I said because
some of my, the most, myfavorite people to talk to actually
are physicians as well.
Because I mean they're on thefront lines.
They're actually the ones whoknow the problems that we're trying
to solve.
So no, I have so much respectfor them and I wish the administrative
(12:54):
burden was not so high.
But anyway, yeah, the wholenother topic there.
So when, when you're buildingout a clinical trial or I guess you're
getting most likely by thetime that teams come to you, they
have a lot of different thingsthat they have in mind.
At what point does it actuallymake sense to start reaching out
(13:15):
and, and looking intosolutions like this?
And because once they get inmy mind what I'm, if I'm a project
manager, I'm thinking, okay,we got a clinical investigation coming
up, it's time to start gettingready for that.
How much time does it take toget these things set up?
What's the, how do you balance that?
Yeah, I mean with.
It varies obviously vendor to vendor.
Some solutions you can have 12month implementations for them and
(13:41):
it obviously depends on the space.
Obviously pharmaceutical aregoing to be longer in that nature.
With Greenlight, I'd say thesweet spot is really three to six
months for teams to come to us.
Obviously coming to us alreadyhaving the study protocol put together
or almost complete ready forsubmission, having their case report
forms or patient reportedoutcomes already developed, super
(14:04):
helpful.
Those are the favorite peoplewe have that like, ah, we love this.
But really at the stage wherethey're focused on that decision
making, focus on evaluatingwhat EDC is going to be the best
move.
If they're working with a CROat that point in time, probably a
conversation that they shouldhave sooner than the EDC because
(14:24):
that process can take a bit.
But that being said, we alsoare bringing in our CRO partners
into conversations and they'reable to work relatively quick.
I think it was just yesterdayactually we have working with a customer
that is starting a study inOctober and they're just starting
to select CROs now.
So getting everything moving quickly.
But again with Greenlightbeing med device focused, our implementation
(14:48):
time frame and speed to gettheir studies stood up in the system
and ready to go live issignificantly quicker than a lot
of solutions out there.
Typically we tell teams fourto six Weeks from contract in place
to ready to go live.
We've stood up studies in aweek before.
We don't recommend that.
We want to give team sometime, a little bit of grace in the
(15:10):
back end, but it can be done.
So yeah, but three to sixmonths, I'd say that's a great timeframe.
As far as planning goes.
It gives you some leeway.
Obviously teams want to dotheir due diligence and look at the
solutions to find somethingthat makes most sense for their needs.
But typically for us that's agreat timeframe.
Okay, so we won't.
I'll try not to repeat the oneweek thing because someone's probably
(15:32):
gonna get onto yours at some point.
But okay, so three to sixmonths, what does that actually look
like?
If you're.
You said from signed contractto studies stood up, what are the
really successful companiesdoing in those three to six months?
Yeah, so I mean, obviouslyfrom my perspective, I'm talking
to them very early on.
So having that initial, justunderstanding of what the scope of
(15:53):
their study is, what is theirtimeframe, really doing that initial
discovery phase and kind ofgiving them that background.
If they're already familiarwith Greenlight and who we are, we're
having that conversation.
Beyond that, obviously we wantto show technical fit.
So we're walking them througha demonstration.
We like to loop in as many ofthe stakeholders, folks that are
going to be involved that wepreviously discussed.
(16:14):
So any of those data managers,clinical operations folks, having
them involved in thatconversation so that they can see
from both the build aspect andmaking sure anyone that's going to
be involved in that process,okay, this is intuitive.
We've got this.
We can easily stand this up ourselves.
And then from the monitoringperspective, when we're looking at
data capture, is this going tobe something that the sites will
(16:35):
easily adopt?
Obviously beyond that there'sother features, functionalities.
We want to be able to showwhat the reporting capabilities,
export functionalities are.
But really you're just tryingto make sure that everything that
they need for this specificstudy and future studies is all encompassing
in our solution and we'll beable to scale with them.
So we're having that conversation.
(16:55):
Obviously then you might haveanother one and bring other stakeholders
into that conversation.
But really we're just tryingto determine technical fit and then
align to their time, timeframe.
So we're kind of workingbackwards in that process.
Once we're determining technofit cost, obviously going through
that aspect, we're contract inplace, bringing in our customer success
team.
(17:15):
So introducing them to whothey're going to be working with
throughout the entirety of the partnership.
So from myself, handing off toour customer success team, then we're
going through this process ofonboarding the team.
And now if they're planning onbuilding, we're going to help them
understand the platform andreally set them up for success in
(17:36):
getting that study built inthe system.
If their team is choosing tobuild it, we'll obviously support
them in that, do a little bitof hand holding and make sure they're
ready to go.
Another service obviously thatwe provide is study builds and validation.
So for teams that don't havecapacity or don't have that experience,
that's something Greenlightcan also take on.
So that's kind of a little bitof that process.
But inevitably we're going tomake sure that their study is set
(17:58):
up in the system, everythingis validated, working the way that
it's meant to, inevitablygetting them ready for steady kickoff.
So that's kind of what'shappening in that three to six month
period.
So the way Greenlight grew,clinical is set up or the way it's
been built, designed,whatever, a medical device company
could purchase this solution,just keep their own just instance
(18:19):
of the software and run theirtrials, or you can use the clinical
research organization, takeadvantage of their network and so
on.
So let's just focus on thatfor just a moment.
So a Croat if we, if we talkabout a CRO purchasing a software
platform and I can almostimagine them having multiple, I don't
know if that's accurate or notor what.
(18:39):
That is very accurateoftentimes and we see both.
But especially you can imaginewith some of the larger CROs out
there, they're working withtens, hundreds of companies and they
probably have three to fiveEDC vendors that they're working
with because it's not a onesize fits all.
So they want to be able tohave that optionality and make sure
that they're finding asolution that's the right fit for
(19:00):
their company or their client.
So what I'm curious about withthose CROs and they've chosen, let's
say they've taken onGreenlight, Guru, Clinical, are there
any things about it that canhelp them win more sponsor business
by using this CDC versus that one?
Any thoughts there?
Absolutely.
So when it comes to anysolution, obviously going back to
(19:21):
having something that'sscalable and being able to repeat
processes, having a prevalidated solution that they don't
have to validate for eachtime, each instance, those things
all go into play there whenwe're talking about winning more
business.
So really the scalability ofthe platform, but then also selecting
a vendor that supports thosebusiness development activities.
(19:44):
So we partner with CROs and weactually support them on business
development initiatives to winmore business together.
Now that can be marketinginitiatives that we run together.
We can support them withoutreach activities on specific sponsors
that they're potentiallybidding on.
So really we work with ourpartners in, in different ways, but
(20:06):
at the end of the day, we wantit to be beneficial for both the
CRO and the EDC vendors.
So definitely having vendorpartner that supports those activities.
Yeah, that makes sense.
And I don't want to tootGreenlight Guru's horn too loud,
I guess, because I, I wantthis to be applicable to any.
Whatever you choose.
You know, you can use this.
You need things to thinkabout, key considerations.
(20:27):
But a vendor like Greenlightgrew with over a thousand customers,
surely there's somebody outthere who could, you know, need your
help.
So that's, that's kind ofsomething to think about.
What about CROs that aresupporting both FDA and EMDR trials?
Maybe even Latin America, allover the world.
We kind of mentioned that atthe very beginning.
How do those EDC platformsstay compliant without making, you
(20:49):
know, extra work for the sponsors?
Absolutely.
I mean, looking for a platformthat is built in validation for both
frameworks.
So FDA 21 CFR part 11 for Esignatures, audit trails, user authentication,
then ISO 14155 aligned with EU MDR.
Those are kind of the keythings I'd say beyond that, just
(21:13):
having standardized compliancestudy templates that can be utilized
across the board and alignedwith GCP.
Again, ISO 14155 study levelconfiguration and custom development.
So just having thosepredefined configurations that lay
out the groundwork for eitherFDA or eumr.
(21:36):
Again, it's something that we,I don't say we get asked it very
frequently.
I think that's just becausecompanies come to us knowing that
we are global at this point in time.
And it's just so common for usto be working with teams that have
studies that are global.
And we're so upfront about thefact that we work globally and we
(21:59):
do, we are compliant with bothEU MDR and we provide all of the
documentation for teams in advance.
So I think the Green LightGuru name itself and just our presence
helps to kind of get messagingout there before we have the conversation
or before I get to the conversation.
Right.
(22:19):
Yeah, there's, it'sinteresting when I think about that
we put the guardrails in place.
That's always been the goal.
And sometimes when I talk tonew prospects about the greenlight
guru, say, let's say qualitymanagement system with the change
control, we have a built inperformance evaluation or evaluation,
I guess it always has thatword perform that throws me.
But there's an evaluation thatyou have to go through.
(22:41):
If you're going to change thedocument, it's going to ask you did
you change, did you change the product?
If you did, did you change the design?
Or, or do you need to gothrough design validation, do you
need to go through design verification?
And maybe I should stop sayingthis but it makes this free text
form and it forces you toanswer the question.
And I typically tell them nowlisten, we can't make, make your,
make sure your engineersaren't lying.
(23:01):
We can't make them tell the truth.
You could still do that if youwanted to, but we at least force
you to ask the question.
So when you put thoseguardrails in place, I don't know
if you've ever bowled with afive year old.
I have a five year old wholikes to go bowling and they put
the bumper up.
He can still get it in theother lane, that kid, you know.
So anyway, bumpers are there,you know.
But you still can't ever turnyour brain off.
Oh absolutely.
(23:22):
I want to, I want to ask you aquestion then because you probably
get asked all kinds of thingsduring the sales process.
Are there any features thatCROs think they need in an EDC but
really they don't.
I mean it, it's also dependenton the study.
Again, this might besomething, if I'm being honest, we
(23:46):
don't really come across.
I'm going to go back to thatprevious response of dashboards.
It's more so just wanting tounderstand like what capabilities
do you have regardless if weneed it or not for this study, they
just want to know.
Oftentimes it's.
Is your EDC integrated withyour quality management system?
That's probably the thing thatI get asked the most.
And then when you put it backon them and ask why they would want
(24:09):
that, they have no idea.
It's just, it feels like theyshould speak to each other when in
fact there is no reason foryour, your EDC system to speak to
your quality management systemand have any interaction there.
I'd say that's probably thething that I get asked most.
But beyond that, again, ushaving a solution built for med device,
we really have all thefunctionalities that would be needed
(24:32):
for any of these studies fromthose early development first in
human through your pivotal andpost market follow up studies.
It's lean but also heavyenough functionalities to ensure
that we have everything thatthese teams need.
I don't think that reallyanswers your question, but I don't
spend a lot on the featureheavy questions.
(24:53):
No, that's okay.
I guess I don't know what mademe think of that, but my wife really
wants a new Ford Expeditionand one of the features she wants
is the back massage thingbecause her friend has a, a version
of that and she sat in thereand she tried the, the back massage
and she's like this is amazing.
So I asked her for him likehow, how often have you used this
back massage?
Like, well, I used it oncewhen I first got it.
(25:15):
I've forgotten about it.
It's been years now.
I'm like well okay, so shouldwe go ahead and spend the extra several
thousand?
I don't know, I mean I wouldprobably use it.
But anyway, if he's thepassenger and you're on a long haul
trip, for sure, 100%.
So anyway, there's alwaysthose things out there that like
oh man, that sounds amazing.
But yeah, okay.
(25:35):
So any I want to ask aboutmaybe hybrid decentralized trials
on the rise?
I wonder if you have anythoughts on how EDCs may be evolving
or how they have evolved tomeet that need.
And are there any things maybeCROs should be asking vendors that
maybe they didn't need fiveyears ago now that they do?
You know, I mean if someone,you know, maybe they've been out
(25:57):
there a while, they've.
Yeah, I'm just, just nowevaluating these things.
Any, any specific questionsyou think they should be asking?
Yeah, I mean I don't thinkthere's too many systems out there
at this point that, thatshouldn't be up to speed with that.
This is the way that the worldis going.
But you do have the, some CROsthat are smaller.
Coming from paper previously,it's still a thing.
Crazy enough, but justunderstanding how do you support
(26:21):
remote data entry?
EPro is one that's, that'shelpful to know and I know not every
Solution does offer ePro.
So for those that don't knowePro, patient reported outcomes giving
you the ability toelectronically send questionnaires
to participants.
So having that functionalityis quite nice.
Multilingual studies, I guessthat's something to look for.
(26:46):
Those I'd say are probably thebiggest things.
Remote data entry I think isprobably the biggest One for them
to ask again.
That's kind of table stakes inmy opinion, at this point in time
for a vendor to have.
Beyond that.
Yeah, I'd say the main things.
Okay, well, this has beenreally fun conversation for me, I
(27:09):
hope for you as well, eventhough I had to trick you into this.
Do you have, if you could giveone takeaway or one piece of advice
to someone who works at a CROwho's listening to this, what would
that one piece of advice be?
Ooh, I guess I'll go back tothat kind of first question of do
your due diligence.
Don't just think about theimmediate need.
(27:30):
Think long term down the line.
Is this going to be a solutionthat we can scale with and is this
going to be a true partner andthat maybe you don't want a partner,
maybe you want a vendor.
But we'll say if it comes downto it and you're looking for a long
haul and you want your team tofind a solution that they can adopt
and it's in the long run goingto save you a lot of time and money
(27:53):
from not having to train onother solutions.
Really look at the platform'scapabilities for not just the study
ahead of you, but down the line.
And then is there somebusiness development initiatives
we can work on?
And yeah, I'd say those arethe key things.
I love the distinction betweenthe partner and the vendor because,
I mean, there are some thingsthat it makes sense to only have
(28:16):
a vendor.
Why would you ever talk to,you know, I don't know.
I've never talked to my Zoom person.
Whoever sold us the Zoominstance that we have, I don't know.
But if, if these clinicalinvestigations are your bread and
butter, the collection and,and the management of all that, it
makes total sense that youwould want just a real close relationship
with those people.
(28:36):
Especially, anything goeswrong, you can immediately get a
hold of customer service.
I, I, man, as I've gottenolder, I have learned a really valuable
customer value, customerservice in so many ways.
But yeah, so I used to be.
I'll do it myself.
No, I want someone to help me.
No one's got time.
Yeah.
Where you you headed aroundthe world?
(28:57):
Any, anywhere anytime soon?
You know, the summer is aquieter time.
I think the sales team'sgonna, we're gonna go to Indy or
Chicago or something at theend of the month.
Maybe London in the fall.
We'll see.
There's a. I hope to see you there.
If you go.
I hope to see you there.
Yeah, that'd be fun.
Any CROs out there listening?
If you're going to be there,hit us up.
We'd love to talk and love toget to know you a little bit better.
(29:21):
But until then, I guess thanksso much for coming on the show, Christine.
I'll let you get back to it.
Live your life again.
And those of you who've beenlistening, thanks so much.
We'll take care.
We'll, we'll take, we'llthanks so much for listening.
We'll see you next time.
Bye bye.
Thanks for tuning in to theGlobal Medical Device Podcast.
If you found value in today'sconversation, please take a moment
(29:42):
to rate, review and subscribeon your favorite podcast platform.
If you've got thoughts orquestions, we'd love to hear from
you.
Email us at podcastreenlight Guru.
Stay Connected.
For more insights into thefuture of medtech innovation.
And if you're ready to takeyour product development to the next
level, Visit us at www.greenlight.guru.
until next time, keepinnovating and improving the quality
(30:04):
of life.
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