Welcome to the Global Medical Device Podcast where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge direct from some of the world's leading medical device experts and companies.

Hey everyone.

Welcome back to the Global Medical Device Podcast.

My name is Etienne Nichols.

I'm the host for today's episode and with me today to talk about clinical solutions and electronic data capture.

And when you're choosing one of those solutions, what do you need to be thinking about?

So I'm calling this episode key considerations for Clinical Research Organizations.

If you've actually been paying attention to this subject or this, this sentence, it's an incredibly run long run on sentence because I was supposed to be introducing someone right now.

But with me today to talk about those key considerations for clinical research organizations is Christine Wilbert.

She is an experienced account executive at Greenlight Guru specializing in edc, which is electronic data capture systems for clinical research organizations, sometimes called CROs.

With over three years, well around three years of hands on experience selling to these different organizations and implementing EDC solutions, Christine's developed a sharp understanding of the unique needs and decision making challenges CROs face in today's future fast evolving clinical landscape.

Her background in business development and clinical operations across North America gives her a well rounded perspective on how CROs can select, scale and succeed with modern digital tools.

And I say North America, but she's really been all over the world selling these things.

I was going to say, I was going to say I feel like majority of our customers are kind of European at this point in time.

Global, but absolutely North American, a wide array.

But great to be here, thanks for having me.

So glad to have you.

And one of the reasons I was so excited to have you on at the end and just those of you listening, I sort of tricked Christine to, I don't know if she actually knew we were going to be recording a podcast today, so apologies for that sort of sorry, not sorry, but she's always.

So you typically have an opinion and whether it's right or wrong, I, I'm a believer in strong opinions held loosely.

So those of you listening, I hope you enjoy this episode.

Absolutely.

Okay, if we were to talk about clinical research organizations and maybe they're looking for an electronic data capture system, what do you think the biggest mistake those CROs make and how do you stop that before it happens?

Absolutely.

So in my experience I would say the biggest issue is lack of due diligence, lack of due diligence of the software and, but also not future planning.

So they're looking for a solution for one particular study.

They're not necessarily thinking down the line, how is this going to scale with this specific company that they're working with?

So if they're just working now on a pilot study of this organization, how is that going to look down the line when they move to that pivotal study?

Is this platform going to be able to support that?

So I'd say that's one of the biggest areas.

Also choosing a solution without necessarily understanding the cost is one thing, but as you get down the line, is there going to be additional costs for amendments?

Are there going to be these hidden fees for support?

Is there going to be that level of support?

So time and time again we see it with, with partners that we've worked at that are coming from other vendors and they finding that there's these hidden costs that if you, hey, if you have amendments for a large study, that adds up very, very quickly.

But also there's support needed and there's a lot of solutions out there that are great.

But it's kind of one of those things where the work is done.

What is that?

After sales support, especially if you're looking at a solution that focuses on pharmaceutical, that's probably going to be the primary place that those companies are supporting the pharmaceutical studies.

Med device probably not going to be their priority.

So another aspect, greenlight.

What we constantly are hearing from customers is our support throughout the sale process.

But once they're signed and partners with us, that after sales support is something that we're constantly getting praised on and it's one of our biggest value adds for teams.

Yeah, and I don't even so me, I'm a poor ignorant fellow over here.

I just do podcasts and talk to people about different things.

I don't even know about the pricing structure of any of these things.

But when you were talking about thinking and beginning with the end in mind and considering the cost down the road, it makes me think of that phrase from Benjamin Franklin.

The bitter bitterness of poor quality remains long after the sweetness of low price is forgotten.

And so whether we, I don't even know how we compare and we don't have to get into that necessarily today, but I do think that's a really valuable point that you make.

So when, when those CROs are evaluating those EDC platforms, you kind of mentioned several things there.

Are there things that you feel like are just, I don't know, vendor noise or just things that people want to throw at them, just different?

I mean, if we were to look at this from how could we help the vendors out?

Like you know what this, this and this really doesn't matter when it comes down to running your trial.

That's those are the bells and whistles that nobody uses.

I mean there's always bells and whistles nobody uses, but anything that you feel like it's just kind 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 that we're we're getting and what we're focusing on time and time again is an intuitive design of solution.

We obviously want this process to be as seamless as possible for teams.

Whether it's the CRO or whether it's the sponsor, the manufacturer that's building the study, we want it to be a seamless process for them.

One aspect we do that it's a no code solution with greenlight which definitely helps that process.

But again with us being medical device specific and medical device focused, the nature of our platform is very intuitive.

It allows for repeatable processes.

So companies specifically contract research organizations, as you can imagine imagine, are managing tens to hundreds of studies at a time.

Having this repeatable process and being able to scale quickly and efficiently with an intuitive system is key.

When you're talking about speed to implementation.

The difference of standing up a system in a few weeks versus six months, as some of the more so generic pharma focused EDCs allow, I.e.

huge for companies specifically in startup where budgets are low, they don't have that time to wait around for a study to start.

So that's another aspect where greenlight really comes in.

Speed, intuitive design, repeatable processes.

So beyond that I'd say items such as just real time visibility, obviously having a pre validated solution that also plays into the speed for teams want to double tap on the importance of having vendor that has a good support throughout the sale and after the sale as well.

So I'd say those are kind of the most important aspects that really matter from a vendor noise more.

So I'd say if you're working on 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 of value adds we say for our med device specific solution is we're more of a lean solution.

We have all the functionalities that a company needs for med device trial.

That to be said, we do have pharmaceutical companies that are using our system.

So it's not that we can just do Med device, but it's more so it's tailored to their needs already.

So I'd say from like a greenlight perspective, we don't really have those features, functionalities that aren't necessary and we're not really, I wouldn't say there's noise on that side, but you do have teams that are coming to us that are asking for specific dashboards.

And dashboards are nice to have.

I mean, we have some out of the box ones and we can build anything with Microsoft Power bi.

But those are more nice to haves for the most part than a need to have.

Yeah.

You know, it's funny, when I went to school, I went to school for mechanical engineering and someone told me once like, oh, that really probably helps you solve a lot of problems.

And it does, it really does.

But at the same time, if I have a problem I want to solve, it's kind of like I've been trained.

Like previously I was a ninja and they've turned me into something of a battleship.

And so I say, okay, there's a little problem, let's turn the battleship and we're going to go down into the physical level.

Sometimes you think, you know what, all we really need is a ninja right now.

And so maybe that's not applicable.

But sometimes I think about that like, oh man, what have we done to ourselves?

When, when you're talking to different teams, I'm curious.

You've probably seen, I mean, you've been here long enough now and, and sold enough, enough seats at the table or clinical trials and et cetera.

I don't know what the right terminology here is.

When you, you, you see somebody really succeeding with their clinical trials who was involved in the thought process from the very beginning.

Yeah, I mean, it depends on the size, type of organization that we're working with.

Obviously you want someone in the clinical operations side of things, someone that sees this day in, day out.

But data managers are key to this process.

They are the ones that are familiar with the EDC systems.

They know what's needed from the site level as well, project managers.

So really anyone that's involved in the day to day, obviously you want the key decision makers involved in that process.

Typically they're coming in more so later in that stage and really they're trusting their clinical operations team to make that decision.

I'd say folks that are left out often are the site users.

And I realize it's difficult to get everybody into these meetings, but one of the aspects that we see from teams, not greenlight because of Course, our system's intuitive, 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 folks that are entering data and others are doing it on paper, then it can end up being a bit of a mess and a little convoluted to try and piece things together.

And that's just not super efficient.

So having those folks involved early on is somewhat helpful.

And that doesn't mean they have to come join the call, but we can share recordings with them, making sure that they have an understanding of the system.

Now, every solution or every vendor should do this, but we do provide site training.

You want to make sure that all the site staff are up to speed and with greenlight, it's nice.

It takes about 30 minutes for the site staff to get trained on the software.

So again, intuitive, simplistic for them to use.

But I'd say site users are probably one of the ones that we'd see.

So the site users, just because I'm not as, I guess, savvy with clinical investigations and so on, is we're talking about healthcare professionals, typically, is that accurate?

Yeah, it can be healthcare professionals, clinicians.

So folks that are actually at the physical locations entering the data into the system.

Yeah.

And it's interesting, there's a lot of talk in the software world about how do you.

How to really break into the healthcare professional world or their, I don't know, their workflows.

I don't know if you have any suggestions on how to.

Actually, I don't.

I hate to say this, but doctors are so busy.

The ad, the administrative burden is just so hard right now.

It's almost like you got to get them and just look me in the eye for a second.

How do you actually get their attention and kind of implement into their workflow?

Any thoughts or suggestions there?

I mean, so that's.

We didn't really speak about doctors in the last one, but there's a lot of physicians that are involved in our conversations.

Typically there's either surgeons or they're lead physicians that are involved.

As difficult as physicians can be, sometimes they seem to quite understand the importance of this process and that's definitely not, not all of them.

We still have the ones that are the.

They want to do this on paper, they're going to do things the old school way, but I haven't seen a ton of resistance.

Honestly, some of my, I don't want to pick favorites, but some of my favorite prospects.

Favorite Customers are physicians and they understand the value of an EDC system and they know that if you want to capt clean data and do it in the most efficient way, this is what you have to do.

Yeah, and I want to just clarify something I said because some of my, the most, my favorite people to talk to actually are physicians as well.

Because I mean they're on the front lines.

They're actually the ones who know the problems that we're trying to solve.

So no, I have so much respect for them and I wish the administrative burden was not so high.

But anyway, yeah, the whole nother topic there.

So when, when you're building out a clinical trial or I guess you're getting most likely by the time that teams come to you, they have a lot of different things that they have in mind.

At what point does it actually make sense to start reaching out and, and looking into solutions like this?

And because once they get in my 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 getting ready for that.

How much time does it take to get 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 12 month implementations for them and it obviously depends on the space.

Obviously pharmaceutical are going to be longer in that nature.

With Greenlight, I'd say the sweet spot is really three to six months for teams to come to us.

Obviously coming to us already having the study protocol put together or almost complete ready for submission, having their case report forms or patient reported outcomes already developed, super helpful.

Those are the favorite people we have that like, ah, we love this.

But really at the stage where they're focused on that decision making, focus on evaluating what EDC is going to be the best move.

If they're working with a CRO at that point in time, probably a conversation that they should have sooner than the EDC because that process can take a bit.

But that being said, we also are bringing in our CRO partners into conversations and they're able to work relatively quick.

I think it was just yesterday actually we have working with a customer that is starting a study in October and they're just starting to select CROs now.

So getting everything moving quickly.

But again with Greenlight being med device focused, our implementation time frame and speed to get their studies stood up in the system and ready to go live is significantly quicker than a lot of solutions out there.

Typically we tell teams four to six Weeks from contract in place to ready to go live.

We've stood up studies in a week before.

We don't recommend that.

We want to give team some time, a little bit of grace in the back end, but it can be done.

So yeah, but three to six months, I'd say that's a great timeframe.

As far as planning goes.

It gives you some leeway.

Obviously teams want to do their due diligence and look at the solutions to find something that makes most sense for their needs.

But typically for us that's a great timeframe.

Okay, so we won't.

I'll try not to repeat the one week thing because someone's probably gonna get onto yours at some point.

But okay, so three to six months, what does that actually look like?

If you're.

You said from signed contract to studies stood up, what are the really successful companies doing in those three to six months?

Yeah, so I mean, obviously from my perspective, I'm talking to them very early on.

So having that initial, just understanding of what the scope of their study is, what is their timeframe, really doing that initial discovery phase and kind of giving them that background.

If they're already familiar with Greenlight and who we are, we're having that conversation.

Beyond that, obviously we want to show technical fit.

So we're walking them through a demonstration.

We like to loop in as many of the stakeholders, folks that are going to be involved that we previously discussed.

So any of those data managers, clinical operations folks, having them involved in that conversation so that they can see from both the build aspect and making 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 monitoring perspective, when we're looking at data capture, is this going to be something that the sites will easily adopt?

Obviously beyond that there's other features, functionalities.

We want to be able to show what the reporting capabilities, export functionalities are.

But really you're just trying to make sure that everything that they need for this specific study and future studies is all encompassing in our solution and we'll be able to scale with them.

So we're having that conversation.

Obviously then you might have another one and bring other stakeholders into that conversation.

But really we're just trying to determine technical fit and then align to their time, timeframe.

So we're kind of working backwards in that process.

Once we're determining techno fit cost, obviously going through that aspect, we're contract in place, bringing in our customer success team.

So introducing them to who they're going to be working with throughout the entirety of the partnership.

So from myself, handing off to our customer success team, then we're going through this process of onboarding the team.

And now if they're planning on building, we're going to help them understand the platform and really set them up for success in getting that study built in the system.

If their team is choosing to build it, we'll obviously support them in that, do a little bit of hand holding and make sure they're ready to go.

Another service obviously that we provide is study builds and validation.

So for teams that don't have capacity or don't have that experience, that's something Greenlight can also take on.

So that's kind of a little bit of that process.

But inevitably we're going to make sure that their study is set up in the system, everything is validated, working the way that it's meant to, inevitably getting them ready for steady kickoff.

So that's kind of what's happening 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 of the software and run their trials, or you can use the clinical research organization, take advantage of their network and so on.

So let's just focus on that for just a moment.

So a Croat if we, if we talk about a CRO purchasing a software platform and I can almost imagine them having multiple, I don't know if that's accurate or not or what.

That is very accurate oftentimes and we see both.

But especially you can imagine with some of the larger CROs out there, they're working with tens, hundreds of companies and they probably have three to five EDC vendors that they're working with because it's not a one size fits all.

So they want to be able to have that optionality and make sure that they're finding a solution that's the right fit for their company or their client.

So what I'm curious about with those CROs and they've chosen, let's say they've taken on Greenlight, Guru, Clinical, are there any things about it that can help them win more sponsor business by using this CDC versus that one?

Any thoughts there?

Absolutely.

So when it comes to any solution, obviously going back to having something that's scalable and being able to repeat processes, having a pre validated solution that they don't have to validate for each time, each instance, those things all go into play there when we're talking about winning more business.

So really the scalability of the platform, but then also selecting a vendor that supports those business development activities.

So we partner with CROs and we actually support them on business development initiatives to win more business together.

Now that can be marketing initiatives that we run together.

We can support them with outreach activities on specific sponsors that they're potentially bidding on.

So really we work with our partners in, in different ways, but at the end of the day, we want it to be beneficial for both the CRO and the EDC vendors.

So definitely having vendor partner that supports those activities.

Yeah, that makes sense.

And I don't want to toot Greenlight Guru's horn too loud, I guess, because I, I want this to be applicable to any.

Whatever you choose.

You know, you can use this.

You need things to think about, key considerations.

But a vendor like Greenlight grew with over a thousand customers, surely there's somebody out there who could, you know, need your help.

So that's, that's kind of something to think about.

What about CROs that are supporting both FDA and EMDR trials?

Maybe even Latin America, all over the world.

We kind of mentioned that at the very beginning.

How do those EDC platforms stay compliant without making, you know, extra work for the sponsors?

Absolutely.

I mean, looking for a platform that is built in validation for both frameworks.

So FDA 21 CFR part 11 for E signatures, audit trails, user authentication, then ISO 14155 aligned with EU MDR.

Those are kind of the key things I'd say beyond that, just having standardized compliance study templates that can be utilized across the board and aligned with GCP.

Again, ISO 14155 study level configuration and custom development.

So just having those predefined configurations that lay out the groundwork for either FDA or eumr.

Again, it's something that we, I don't say we get asked it very frequently.

I think that's just because companies come to us knowing that we are global at this point in time.

And it's just so common for us to be working with teams that have studies that are global.

And we're so upfront about the fact that we work globally and we do, we are compliant with both EU MDR and we provide all of the documentation for teams in advance.

So I think the Green Light Guru name itself and just our presence helps to kind of get messaging out there before we have the conversation or before I get to the conversation.

Right.

Yeah, there's, it's interesting when I think about that we put the guardrails in place.

That's always been the goal.

And sometimes when I talk to new prospects about the greenlight guru, say, let's say quality management system with the change control, we have a built in performance evaluation or evaluation, I guess it always has that word perform that throws me.

But there's an evaluation that you have to go through.

If you're going to change the document, 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 go through design validation, do you need to go through design verification?

And maybe I should stop saying this but it makes this free text form and it forces you to answer the question.

And I typically tell them now listen, we can't make, make your, make sure your engineers aren't lying.

We can't make them tell the truth.

You could still do that if you wanted to, but we at least force you to ask the question.

So when you put those guardrails in place, I don't know if you've ever bowled with a five year old.

I have a five year old who likes to go bowling and they put the bumper up.

He can still get it in the other lane, that kid, you know.

So anyway, bumpers are there, you know.

But you still can't ever turn your brain off.

Oh absolutely.

I want to, I want to ask you a question then because you probably get asked all kinds of things during the sales process.

Are there any features that CROs think they need in an EDC but really they don't.

I mean it, it's also dependent on the study.

Again, this might be something, if I'm being honest, we don't really come across.

I'm going to go back to that previous response of dashboards.

It's more so just wanting to understand like what capabilities do you have regardless if we need it or not for this study, they just want to know.

Oftentimes it's.

Is your EDC integrated with your quality management system?

That's probably the thing that I get asked the most.

And then when you put it back on them and ask why they would want that, they have no idea.

It's just, it feels like they should speak to each other when in fact there is no reason for your, your EDC system to speak to your quality management system and have any interaction there.

I'd say that's probably the thing that I get asked most.

But beyond that, again, us having a solution built for med device, we really have all the functionalities that would be needed for any of these studies from those early development first in human through your pivotal and post market follow up studies.

It's lean but also heavy enough functionalities to ensure that we have everything that these teams need.

I don't think that really answers your question, but I don't spend a lot on the feature heavy questions.

No, that's okay.

I guess I don't know what made me think of that, but my wife really wants a new Ford Expedition and one of the features she wants is the back massage thing because her friend has a, a version of that and she sat in there and she tried the, the back massage and she's like this is amazing.

So I asked her for him like how, how often have you used this back massage?

Like, well, I used it once when I first got it.

I've forgotten about it.

It's been years now.

I'm like well okay, so should we go ahead and spend the extra several thousand?

I don't know, I mean I would probably use it.

But anyway, if he's the passenger and you're on a long haul trip, for sure, 100%.

So anyway, there's always those things out there that like oh man, that sounds amazing.

But yeah, okay.

So any I want to ask about maybe hybrid decentralized trials on the rise?

I wonder if you have any thoughts on how EDCs may be evolving or how they have evolved to meet that need.

And are there any things maybe CROs should be asking vendors that maybe they didn't need five years ago now that they do?

You know, I mean if someone, you know, maybe they've been out there a while, they've.

Yeah, I'm just, just now evaluating these things.

Any, any specific questions you think they should be asking?

Yeah, I mean I don't think there's too many systems out there at this point that, that shouldn't be up to speed with that.

This is the way that the world is going.

But you do have the, some CROs that are smaller.

Coming from paper previously, it's still a thing.

Crazy enough, but just understanding how do you support remote data entry?

EPro is one that's, that's helpful to know and I know not every Solution does offer ePro.

So for those that don't know ePro, patient reported outcomes giving you the ability to electronically send questionnaires to participants.

So having that functionality is quite nice.

Multilingual studies, I guess that's something to look for.

Those I'd say are probably the biggest things.

Remote data entry I think is probably the biggest One for them to ask again.

That's kind of table stakes in my opinion, at this point in time for a vendor to have.

Beyond that.

Yeah, I'd say the main things.

Okay, well, this has been really fun conversation for me, I hope for you as well, even though I had to trick you into this.

Do you have, if you could give one takeaway or one piece of advice to someone who works at a CRO who's listening to this, what would that one piece of advice be?

Ooh, I guess I'll go back to that kind of first question of do your due diligence.

Don't just think about the immediate need.

Think long term down the line.

Is this going to be a solution that we can scale with and is this going to be a true partner and that maybe you don't want a partner, maybe you want a vendor.

But we'll say if it comes down to it and you're looking for a long haul and you want your team to find a solution that they can adopt and it's in the long run going to save you a lot of time and money from not having to train on other solutions.

Really look at the platform's capabilities for not just the study ahead of you, but down the line.

And then is there some business development initiatives we can work on?

And yeah, I'd say those are the key things.

I love the distinction between the partner and the vendor because, I mean, there are some things that it makes sense to only have 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 Zoom instance that we have, I don't know.

But if, if these clinical investigations are your bread and butter, the collection and, and the management of all that, it makes total sense that you would want just a real close relationship with those people.

Especially, anything goes wrong, you can immediately get a hold of customer service.

I, I, man, as I've gotten older, I have learned a really valuable customer value, customer service 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 around the world?

Any, anywhere anytime soon?

You know, the summer is a quieter time.

I think the sales team's gonna, we're gonna go to Indy or Chicago or something at the end 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 to get to know you a little bit better.

But until then, I guess thanks so 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 been listening, thanks so much.

We'll take care.

We'll, we'll take, we'll thanks so much for listening.

We'll see you next time.

Bye bye.

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