Meet SCRS Global Impact Partner: Science 37

Meet SCRS Global Impact Partner, Science 37! Dr. Debra Weinstein, Vice President of Internal Medicine, discusses Science 37's dedication to site success and collaboration. Hear insights into Science 37's initiatives, including their referral network and recruitment strategies, as well as their groundbreaking Metasite™ model.

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Jimmy Bechtel 0:00

Greetings, and thank you for being part of the Society for Clinical Research Sites on SCRS Talks. I'm your host, Jimmy Bechtel, the Vice President of Site Engagement. Get ready to dive into a space where we discuss pressing clinical research industry issues, celebrate noteworthy achievements, and foster a deeper connection with the research community. This is a space to amplify voices and perspectives that shape the landscape of clinical research. Today we have Dr. Debra Weinstein, the Vice President of Internal Medicine with Science 37 here to share a little bit more about why Science 37 chose to join the SCRS global impact partnership program. Debra, it's great to have you with us today, really excited that Science 37 has joined the global impact partnership program. I'd love to start things off and learn a little bit more about you and Science 37.

Debra Weinstein 0:51

Sure. Well, my name is Dr. Debra Weinstein. I'm an internist by training. I spent 15 years as a regular doctor in primary care, always doing a little bit of research on the side. Then I went into full time clinical research and spent another 15 years as the chief medical officer at a very traditional brick and mortar site, multidisciplinary site where we did work both in and outside of the hospital. And then in 2017, I joined the Science 37 team and transitioned from that traditional model into the virtual model of clinical research. Currently I serve as vice president of internal medicine. I have many roles at Science 37, but most notably as a principal investigator on many of our studies with the primary role to make sure patients are safe and we're doing studies correctly and that we are really obtaining quality data.

Jimmy Bechtel 1:48

That's great. Well, again, thank you for being here and we're very excited to have Science 37 as part of the Global Impact Partnership Program. So, would you mind starting us off maybe with a little bit more about Science 37 and how this partnership aligns with Science 37's mission and values?

Debra Weinstein 2:08

Sure. So Science 37 was founded in 2014, and we've really been pioneering the concept of patient centric trials. So we reduce the impact of geographic barriers that are associated with conventional brick and mortar sites by bringing research into the patient's home. So we're powered at Science 37 by our technology platform. We have a full team of broadly licensed physicians, a large team of research coordinators, who are located in different time zones, a network of research trained nurses and a robust support team. So we are dedicated to the research community and to our patients. And we know that SCRS is dedicated to representing the interests of the clinical research site community. So partnering with you really enables us to be even more outspoken with all stakeholders involved in clinical research from sponsors to the FDA and then to the global research community.

Jimmy Bechtel 3:08

That's great Debra. It's awesome to hear that our two organizations are so aligned and can continue to provide value for each other. And I do want to dive into specifically kind of the bread and butter of Science 37's business model and that is of the Science 37 meta site. And how does that model and that construct really aim to address the challenges faced by traditional study enrollment methods?

Debra Weinstein 3:34

Sure. So the meta site is the term that we use at Science 37 for our site without walls. So what does that mean? We basically can provide access to 100 percent of the patient population because we operate our clinical trial from coast to coast with investigators that have multi state licensures. Our home health providers that can accommodate the participants availability, reducing travel for the patient's, time and cost. We have a remote study team that manages all the participants. We do direct I. M. P. Shipment to the patient's home and we all are contracted under one 1572 and one IRB submission, then allows us to operate in all 50 states. So we are a site. We're just a site without walls. So how that works is that there's a principal investigator who signs on the 1572 and then say, if it's me, I will develop a team of sub investigators to make sure that. We can cover the entire geography for the study. So some sponsors want us to cover all 50 states and we're able to do that, or we're able to be located in certain geographic areas. But we make sure that we have investigators that are able to see the patients in the states where they have licensure and the patient is located. We then have a group of patient experience coordinators and these are intake coordinators that get a lot of preliminary information from patients often will go through a prescreening eligibility, even obtain medical records for review before we put the patient into screening to eliminate our screen failure rate, make sure we're, really getting qualified participants. Then we have our research coordinators that are located in all time zones so that they're able to be assigned to a patient where it's going to be convenient for that patient. And then our mobile health care providers, which are mostly are very detailed oriented research trained nurses, and they are trained both in G. C. P. They are trained on all of our internal standard operating procedures as well as very specific training on each protocol and schedule of assessments. And so this whole team is united under our clinical study leader. A project manager that will serve as liaison between us and the sponsor and CRO. And then we have a support team that includes our medical affairs team. So we have physicians of many different specialties. We have our own internal quality and compliance, which really make sure that we are in line with all regulatory requirements and that if any issues do come up in a study that we're reviewing adverse events and protocol deviations. And then we have since we have our own technology platform or our electronic source because we don't use paper ever. We have our own internal technology team that assists us with operations. So we formed this team and we are ready then to take a protocol and see if it's amenable to our model and see if we can stand up either alone or alongside brick and mortar sites. And that's important. We're not eliminating brick and mortar sites. We are often really able to fill in the gaps. So, if you think that a brick and mortar site will be able to see patients, say, within a 50 or maybe even 100 mile radius from their actual site. We are able to fill in all that other space because we can see really a patient who's anywhere our nurses travel. With full laboratory supplies and equipment like E. K. G. Spirometry, lab supplies, just to name a few of our standard testing. And we work with an expansive network of patient communities and referring providers, physicians to reach patients again where they are. So, whether they're in downtown New York City, or in rural Arkansas. We're really able to enroll from anywhere. And so I really do think that that addresses so many issues with Recruitment So our patients do not need to travel to a site. So, things like childcare and travel are not a roadblock. Our participants are eager to participate and more likely to be compliant, not just with visits, but with long term follow up, which as you know, can be a significant issue. And we're also able to recruit faster because we open up the entire country if that's what we set up with our one site under one 1572 so with that broad reach our recruitment strategies really attract just by nature of the way we do things a very diverse patient population. And this is really a very significant challenge that the industry. Is struggling with so we can localize our recruitment to a specific area or even a specific underserved area or areas with a specific population if the sponsor needs that or we can do things quite broadly and our data really consistently shows that when we compare where we end up with about a three times more diverse population than the conventional trial site. And I think when we combine all these processes, we're really able to enroll. It depends on the study, but an average of 20 times more patients than a conventional site on the same trial. And we're really becoming a cornerstone to most sponsors enrollment strategy and an excellent compliment to the traditional site network

Jimmy Bechtel 9:12

Thanks, Dr. Weinstein. It was a thorough explanation and really, really interesting to hear the approach that Science 37 takes. I think there's a lot of really valuable information in here for not only our site audience, but also our sponsor, CRO and other service provider audience as well in how you are truly a supplement to the need that exists in our ecosystem. And just looking at kind of kind of taking the traditional site construct and flipping it on its head in a lot of ways, but still remaining true to what it means to be a research site and enrolling patients, treating them safely and fairly, and getting data back on behalf of those patients and patients that are waiting for medicines to the sponsors so that we can bring new medicine to market. So really interesting approach there. And I again appreciate your thorough explanation. In addition to that meta site construct that you explained, what other initiatives or programs is Science 37 working on that you might be really excited about and maybe also share how that will ultimately then impact the clinical research site community?

Debra Weinstein 10:18

Sure, I think one thing recently really we've been building up is our referral network and our recruitment team. And so in addition to working as a site, we're also providing recruitment for sponsors, and CROs, and sites and we have really this unique method to identify, prescreen with early medical record access and review, to provide quality candidates for almost all types of study indications. I think personally, I'm most excited about how the virtual model has really become more and more accepted within the global research community, and even the FDA has provided guidance and increasing encouragement on our model, and I really do think the future of our approach looks bright. I think I'm excited about the depth of types of studies that we're able to do in the home. I just wanted to give a few examples. We recently launched one of our first trial using remote in home spirometry for a top pharmas asthma trial where our research nurses were able to really ensure quality data resulting from that in home spirometry and our physicians, really important that our physicians and even contracted respiratory specialists observe the testing through video conference. So we are there with the participant and the nurse, even though we're not co located where they are on a video conference. We've also operationalized a 60 hour at home infusion for a postpartum depression study. And I just thought being involved with that was incredible because the magnitude of that study in terms of reducing patient burden, for new mothers with depression was really groundbreaking. We also had a recent breast cancer biomarker study where we delivered more than 2000 home nursing visits. I think that it's interesting to see the variety of studies we're able to do from large studies and enroll thousands of patients to others where we're dealing with very rare diseases and hard to find patients where a sponsor would have to open up so many sites in order to capture the amount of patients necessary. So all these things are just so exciting, but what we're doing, the acceptance that we're having, the quality data, and from my perspective, the patient safety measures and the guardrails we've been able to put in place. Again, I was in the traditional brick and mortar environment and moved into this virtual model. And I can tell you that from an oversight perspective and from patient safety, this is really moving the needle in the way we're going to approach protocols.

Jimmy Bechtel 12:52

I love it. Dr. Weinstein, it's great to hear some real life applications. I think the postpartum depression study is a really great example of one that can value so tremendously with remote enabled technology because you're right. These new mothers are Not only battling their condition, but also trying to figure out how to be a new mother on top of all that, which is just compounding. So these are great examples of where we can build systems and programs and new models like what Science 37 is doing to help these patients where they need it most. So again, congratulations on those studies and those advancements. And it's great to hear what you're able to do in that space. Dr. Weinstein, as you know, site sustainability truly is the number one priority for SCRS and our partners. So, I'd like to begin to conclude our conversation with asking you how Science 37 is then working to ensure your success and site success in general, in the clinical research ecosystem.

Debra Weinstein 13:59

Sure. I think for our model, for Science 37s model, it's very, very important to understand that we evaluate each protocol very carefully to make sure that the schedule of assessments is appropriate. I always like to say that we will never do a liver biopsy in somebody's living room. But the approach to seeing patients in their home and enabling easier access to clinical trials is only expanding as we explore our capabilities, and I think reaching patients wherever they are easing the burden of recruitment, improving diversity, exceeding enrollment goals faster. I think all that will ensure that at Science 37 we will help to move the needle forward and acceptance of the virtual model. And I think broadening trial access and showing quality data. With, very important, with expert oversight really will help to ensure our success in the clinical research ecosystem.

Jimmy Bechtel 15:00

Excellent. And what I heard from that, what I take away from that explanation, Dr. Weinstein is that we have a lot of learning and assurance, right? We can do this looking at a company like Science 37. It gives the other sites that are out there that assurance or that hope and that ability to say, yeah, this is doable companies like Science 37 are doing this and so can we. And if we want to be able to do some of the things that you have mentioned, right bring the trial to the patients, enable the patients in their home or at a remote location, then we need to think about how this is being done. And I think we have a lot to learn from organizations like yours, and you have a lot of really valuable insights to share with the community. So it's great to hear that that's the mindset that Science 37 is approaching this relationship with. But I do want to, you know, thank you and thank Science 37 for joining the global impact partnership program and perpetuating that dedication to the clinical research site community. And of course, thank you for being on the call with us today and discussing how Science 37 is making a difference.

Debra Weinstein 16:10

Thank you so much. We're so excited to be a part of this partnership. And again, to forward and advance clinical research in both the virtual and the traditional model to make sure that we're keeping patients safe. We're doing quality work and we're bringing new drugs to market.

Jimmy Bechtel 16:30

Well, thank you again. And that's excellent to hear. And as we wrap up, don't forget to our listeners to explore more site focused resources on our website myscrs.org you'll find a wealth of content and publications, plus the opportunity to save your spot for an upcoming webinar or SCRS summit being held throughout the year. Thank you for tuning in and we can't wait to have you back for even more enriching content. Until next time. Thanks for listening.