From Feedback to Innovation: Cognizant's Responsive Approach

Hear from Dr. Lestter Cruz Serrano, the Global Head of Medical Affairs at Cognizant Health Sciences Group, as he shares the intricacies of site advocacy in clinical research. Discover how Cognizant's Shared Investigator Platform (SIP) has evolved over the past four years to address challenges faced by clinical research sites. Utilizing insights from an SCRS Site Advocacy Group (SAG), Cognizant shares the impactful enhancements made to SIP based on valuable site feedback. Gain insights into the future of SIP and the role of sites in driving its innovation.

Transcript

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 with the Society. Get ready to dive into a space where we discuss pressing clinical industry research issues, celebrate noteworthy achievements, and foster a deeper connection within the research community. This is a space to amplify voices and perspectives that shape the landscape of clinical research. Today, we have Dr. Lestter Cruz Serrano, the global head of medical affairs with the Cognizant Health sciences group here to share a little bit more about recent updates with the shared investigator platform as well as the site advocacy group that Cognizant has been utilizing to gain site feedback into their products and platforms for quite a while now. Lestter, it's great to have you back with us and sharing your perspectives on this important aspect of how we execute our clinical trials, as well as the wonderful work that Cognizant is doing to listen to the sites. So I'd love for us to start off first with a brief introduction from you.

Lestter Cruz Serrano: 1:08

Thank you, Jimmy. And we are honored and excited to be here at SCRS Talks. And today we'll be sharing some insight about our learnings and lessons learned through our site advocacy groups. As you just mentioned in that introduction, my name is Dr. Lestter Cruz Serrano, global head of medical affairs in the Cognizant health science group. And I've been working with Cognizant for five years now. Prior to my current role, I led the hematology and oncology studies for NIH cooperative group and the pharmaceutical trials at CHI Health, and spent some time before that as a Celerion CRO conducting applied translational medicine with phase 1 and phase 2A oncology trials for multiple pharmaceutical companies. Additionally, I've also led phase 2 and phase 3 clinical trials for patients with conditions such as diabetes, endocrinology metabolic disorder, and cardiovascular disease at Nebraska Medical Hospital and also the University of Nebraska Medical Center. And during that time, I also contributed to a large model of care for dementia patients called the CARE ecosystem, which was designed to provide a more personalized, cost effective care for people with dementia and their caregivers. So, as you can see, I've had multiple experience throughout the life sciences life cycle, but like many others, my journey began with science and medicine studies in biology and pre medicine studies in the University of Puerto Rico. I then obtained my MD degree from UAG School of Medicine and followed by specialized training as a family physician. And I currently hold the board certification from the ACMA. That's a board certified medical affairs specialist, and I'm currently pursuing my MBA title.

Jimmy Bechtel: 2:59

Thanks Lestter. Can you maybe dive into as well, a little bit more about your role specifically within Cognizant?

Lestter Cruz Serrano: 3:06

Absolutely, Jimmy. I was brought as a medical advisor, but in my current role, I have been spearheading our companies effort in driving the medical strategy for the Share Investigator Platform, SIP for short. SIP is the 1st industry open SAAS clinical ecosystem alongside multiple pharmaceutical companies. In addition, we are developing also strong KOL and thoughtful leaders relationship at the local, regional, national, and international level for SIP adoption across major hospitals in over 100 countries. So, as you can imagine, our role is to try to do a deeper dive, get insight, bring that in house so that we can make sure that we are advising our company to make the right decisions as we move forward. So my work with Cognizant involves also a close collaboration with the SIP biopharmaceutical sponsors to assist with system adoption and at prestigious sites worldwide.

Jimmy Bechtel: 4:07

Thank you, Lestter. We're here to talk a little bit about that site advocacy group that we know you've had in place and is really focused on the site perspective on the Shared Investigator Platform. And it's great to see now, which seems like time has flown back in 2021 when you began this site advocacy group to garner feedback on that platform. It's, now evolved and it's still in place here going on almost four years. Why then was it important for Cognizant to hear feedback directly from sites on this platform?

Lestter Cruz Serrano: 4:43

Thank you, Jimmy. And yes, I think like you said, almost four years ago. We went into an SCRS conference and we learn about the site advocacy groups and the importance to bring that site feedback to the table in order to make your products be more successful. And we took that advice again, almost 4 years ago. So now we believe that at the inception of SIP, most of the features, requirements, when we look back were mainly influenced by the SIP sponsors who actively took part of that TransCelerate consortium. For those who are not too familiar with TransCelerate, they are a non for profit organization with a mission to collaborate across the globe with biopharma and R& D community by bringing innovation and ideas to accelerate and expedite the activities within life sciences. So, in contrast, globally dispersed clinical research sites were gradually introduced to the platform by the respective sponsors based on specific trial demand. So unlike the sponsor, there was no formal consortium or collective body for the sites, which could serve as that central hub for disseminating essential knowledge about SIP. So, consequently, the sites found themselves playing catch up with the features, learning on the fly as they set up their profiles and studies within SIP. So, to summarize, several factors compounded, right, to the challenges faced by the sites, including inadequate training and guidance, limited site awareness regarding the problems SIP aimed to address, and the absence of a dedicated forum for sites to directly share feedback and express their requirements. I think in addition, sites struggle to identify central teams or individuals responsible for managing site profiles within SIP.

Jimmy Bechtel: 6:47

Well, it's great, Lestter, that you all have identified those challenges and are able to clearly articulate them because from what we understand, yes, those are some major challenges that the sites face with the Shared Investigator Platform, and we all know in order to be able to solve those challenges, we first have to be able to kind of put a pin in them. So it's great to hear again that you all have clearly identified some of the major challenges again that the sites face. So as a result, then, Did Cognizant decide to form the Site Advocacy Group after understanding all of those challenges, or where did understanding those challenges then lead you in terms of the Site Advocacy Group?

Lestter Cruz Serrano: 7:24

Yeah, I think that, as I mentioned, talking with the sites, having conversation, and it was at this critical juncture that Cognizant made a strategic decision to collaborate with SCRS as a global impact partner, recognizing SCRS extensive reach within the site community in order to improve our relationship with our sites. So right away, Cognizant form a site advocacy groups or SAG, which was comprised of a unique, but well rounded mix of site personas, like investigators, CEOs, site operational managers, regulatory experts, et cetera. And this ensure that the feedback was collected from all levels of site stakeholders. See, the primary goal of the SAG was to create a unified site forum for SIP, serving as that collective voice of sites within industry. And these SAG members actively share their current processes, validated and review early prototypes of upcoming platform features, and provided valuable feedback and suggestions to prioritize site needs. In fact, about at that same time, Cognizant also started a dedicated SIP task force with the AACI, the Association of American Cancer Institute, where representatives from different AACI cancer centers across the nation came together to share feedback and provide suggestions to help improve the SIP user experience. We also had sponsors join these calls to hear what the sites had to say, and this will ensure that sponsors were directly informed of some of the site challenges.

Jimmy Bechtel: 9:13

That's great, Lestter. It's so awesome to hear that as a result, right? We are working on these things. We're trying to address them. We're trying to fix them and hear directly from those sites. So thank you for I guess your emphasis and understanding that you're not going to be able to do this alone and not assuming that you have all the right answers through the formation of something like the site advocacy group. It's great to hear and I agree with you. It's a really great platform to be able to make change, particularly around things like technology and technology solutions. So then, Lestter, what steps have been taken by you and the rest of the Cognizant team to then integrate the feedback that you've received from the Site Advocacy Group and other avenues through Summits? I know you have conversations around this at Summits as well, and address some of those opportunities to improve and make positive change as a result of that feedback within the platform.

Lestter Cruz Serrano: 10:12

Absolutely. I mean, looking at the feedback received from the initial and subsequent SCRS site advocacy group, Cognizant recognized unmet needs among clinical research sites, and the sites were actually seeking greater collaboration and support to bring their feedback to the table, which will improve site experience with SIP. As a result, Cognizant decided to invest in nurturing site relationships globally to transition as engagement from a purely operational to a more strategic one. And Cognizant established a Global Medical Affairs team specially for the Shared Investigator Platform I think in early 2023. I currently lead this team today. Cognizant's Global Medical Affairs team is comprised of both industry experts as well as product specialists, who are extremely knowledgeable about the platform. And their primary mission is to act as the voice of the site community, gathering valuable information and insight from interactions with various research sites. And this team ensures that the site discussions are impactful and meaningful. By communicating in a language that is understood by KOLs or thoughtful leaders or investigators or research directors, makers at the site level. So working closely with sites and sponsors and their clinical operations teams and their CRAs, the Global Medical Affairs team facilitates streamlined collaboration for sites. Enhancing the overall site user experience and SIP adoption. In order to establish that strategic relationship and partner of the sites, the Global Medical Affairs team had to come up with several key channels of engagement and to mention a few, we have our focus site advocacy group, which we have with SCRS and organizations like the AACI, where we do a deeper dive within the modules, processes, workflows, and make sure that what we are bringing in the forefront of a capability or functionality makes sense. But we also have some regional site advocacy groups where every end user from a SIP perspective are able to take part and have a seat at the table in order to shape or reach the road map of the Share Investigator Platform, and these are are done again within all the regions, North America, Canada, Latin America, Europe and Asia. Another area is a strategic partnership with site networks and organization. Being present in their events as a partner and collaborate with the sites and focus in different events, like the SCRS global site summit. And lastly, customized site workshops and webinars, which are tailored to specific needs where best practices and lessons learned can be shared with our sites. In addition, the Global Medical Affairs team has also developed bimonthly governance meetings with our SIP sponsored leads to strategically align in support of the site's needs. This comprehensive approach ensures that Cognizant stays actively involved in supporting and empowering our clinical research sites. As you mentioned earlier, it takes all of us to make sure that we are making the right progress. So internally, the Cognizant Global Medical Affairs team works cross functionally as a conduit disseminating site needs and issues to the different internal teams within Cognizant. A few examples of these will be leadership. Product management, legal, compliance, support, engineers, working closely with all of these internal stakeholders, we put together a priority list from all the SAG feedback in our SIP product backlog. And last time I checked by Q4 of 2023, most of the feedback had been addressed either via a new feature or an enhanced or currently functionality.

Jimmy Bechtel: 14:24

Excellent. What I really liked about your explanation here, and thank you for the tremendous amount of detail into all the different aspects that you've managed to modify, is that it's multifaceted. There isn't just one path or one approach that you're taking to try to make those improvements to the platform. You're listening and truly trying to address them systemically throughout the organization and across the product life cycle. I think that's such a huge and rare thing that we see in this industry. We always tend to see simple solutions, one path to one type of outcome. Instead of really trying to tackle the problem at a macro level. Across, like you had said, you're involving different teams, management, legal, compliance. It's just so rare. So I applaud Cognizant's dedication to taking that approach and really implementing it at an institutional level. Lestter, can you then share some of these key enhancements or maybe a little bit more detail around features that have been implemented for improving that site experience in the SIP. So kind of taking some of the general feedback and the processes that you've done to maybe highlighting again some of the specific features or enhancements. I'm sure sites listening who may have missed the memo would love to know what specifically has been worked on as a result of this institutional modification process.

Lestter Cruz Serrano: 15:52

Absolutely, Jimmy. Yes, of course. And I think after four years of conducting these site advocacy groups and all the feedback and all the information that we've gathered from our site, I think that some of the impactful changes, which we have already been implemented for the SIP, and I'll mention just a few, but the main ones enabling centralized office or site managers to manage delegates on behalf of the investigators. At the beginning, we had the PI, the investigator at the center of every decision that was made towards the tasks or the activities in the platform. And right away, we learned that having delegation capabilities, thereby reducing the dependency of the PI and the system is something that the sites were all rooting for. For so we've already worked on those delegation capabilities, another one, simplification of new site user registration process, eliminating almost all manual data entry and making the registration as simple as possible. Automatic access to relevant study based on pre configured setup immediately after account creation, thereby reducing multiple steps and dependencies again on the PI or other staff. A big one for us and for all of our site users. Improving the system performance, almost 90 percent of all the pages across different screens and actions today are under three seconds and touching the two second mark. So we're always looking to improve the system performance, which I know is a big thing, not only for us, but for our site users as well. Flexibility with individual site users to manage their own notification settings and being able to set those in their profile so they can have the frequency that works best for them based on their role and usage of the system. We just launched our mobile app last year. And now we have biometric enable SIP mobile app capabilities to help respond to pending action and access SIP without the need of explicitly providing username or password for login, quick access to study documents, following conceptual links in email, hence reducing dependencies on searching. See here, if I'm already logged in SIP and I get that email and I click on the link, it's going to take me directly to the task that needs to be completed versus in other times you had to go and continue to log in and then go through the whole login process. And finally, centralized control with site and networks managers to administer and oversee site staff access. And these are just a few. There's many more other usabilities improvements that are coming or that have already been implemented in the system.

Jimmy Bechtel: 18:55

Excellent, Lestter. I'm sure our listeners are thrilled to hear such a list of improvements. Again, going back to that point, I made not one or two things, but several things that I know have been pain points at the site level. So thank you and thank you to the Cognizant team for the dedication to implementing those changes as quickly, effectively, and purposefully as possible. So then how have sites responded to the changes made by Cognizant? I'm sure you've had we've had numerous opportunities given that I know some of these changes have been in place for a good amount of time now. Talk to me a little bit about the reception of some of these changes, both anecdotally and maybe data supported.

Lestter Cruz Serrano: 19:37

So first, we want to thank our sites for being patient, and we understand that SIP is not a complete product by no means we continue to work daily, weekly on this platform and continue to try to bring the capabilities, functionalities and enhancement that are going to make SIP the global operational tool of the present and the future. But while we understand that there are still a lot of opportunities for improvement. However, in our current position we are delighted to see the recognition from clinical research sites regarding the positive transformation that has been implemented. See, these changes extend beyond mere system functionality and encompass site relationship management as well. Testimonials from the sites now attest to their improved user experience with the Share Investigator Platform and their value interaction with the Cognizant Global Medical Affairs team. This sentiment is further echoed in the recent concluded SIP Annual Survey for 2023, which we just completed a few months ago, where Sites acknowledge the benefit of using the Shared Investigator Platform as a sole operational tool for their sponsored trials. If we look at some of these key metrics from the SIP annual survey from 2023, there was a few that stood up and I want to mention them here. The first one, the NPS score or the net promoter score, which is a custom loyalty evaluation or score from site has increased by over three folds compared to 2022. Another one is the number of promoters and supporters from site perspective, which is more than eight times that of the previous year. And then lastly, a significant majority of the site respondent, almost 60%, have expressed a tangible benefit they derive from engaging with the Cognizant Global Medical Affairs team. Also we have some voluntary video and written testimonials from sites across the globe with more to come that also allude to that improvement and improvement in the end user experience. In fact, we have been able to publish some of our latest metrics and feedback from sites as an industry case study in the SCRS website on how Cognizant's Global Medical Affairs team has been able to align SIP roadmap to site needs globally. And we thank SCRS for the collaboration and support with this ongoing journey.

Jimmy Bechtel: 22:15

Well, you're very welcome, Lestter, and I think it's so important for us as a partnership to make sure that we have channels like that to share the improvements with the broader site community, right beyond the site advocacy group and beyond the conversations that you're having, and your intimate and very purposeful meetings, but being able to bring that information back to the greater site population, I think, is a really important aspect of the work that we do together to improve the work and ease the burden on the clinical research sites. So, Lestter, as we wrap things up here, let's talk a little bit about the future. What can our sites then expect from Cognizant and the Shared Investigator Platform going forward?

Lestter Cruz Serrano: 22:57

Thank you, Jimmy, for that question, and we're very excited about the future. See the SIP annual survey that just concluded in 2023 shows that there are still considerable number of sites, roughly 34 percent who are yet to interact with the Cognizant Global Medical Affairs team. So that's an area as we look forward to 2024 and beyond, we intend to expand our Global Medical Affairs team across strategic countries and continue with the site advocacy groups to support our sites globally, get their voices heard and share their message to other stakeholders so that we can build a truly single combined operational platform that works for all. Importantly, based on site feedback, Cognizant is evaluating specific enhancement which will further simplify the site user experience, reduce their redundant actions, improve intuitiveness, and bring an integrated ecosystem for sites. Also, as part of our product roadmap, we are evaluating multiple AI enabled use cases. I'll give you an example, AI enabled chatbot, where to help with how-to queries, pre-fill and suggest responses to sites while responding to surveys, based on site capabilities and previous responses. That could be an example, but also, we are evaluating multilingual capabilities to ensure a truly global adoption by sites. So you can see that the future is very bright for SIP and we think that SIP is very well positioned, unique position to serve the global audience or the global communities of our sites.

Jimmy Bechtel: 24:43

Excellent, Lestter. Well, it was great to have this conversation. I know that because of the importance of the Shared Investigator Platform for our industry that updates on what is being done, what has improved and what the future looks like for this platform are so important to our global site audience. So thank you for taking the time to share some of those updates with us today. And again, thank you for being with us. Any last words before we, finalize things and conclude for the day.

Lestter Cruz Serrano: 25:13

Yes. Thank you, Jimmy. I want to express my heartfelt gratitude to our sponsors, our sites, vendors who have collaborated to shape the Share Investigator Platform into an inclusive and dynamic clinical trial operations platform. The validation of our effort is truly rewarding and I was thrilled to get this podcast opportunity to present the insights gathered from our SCRS SAG workshops. Finally, to all of our dedicated sites and sponsors, thank you for placing your trust in SIP and embarking in this transformative journey alongside us, and we look forward to coming back to your podcast in 2025 so that we can share our updates from 2024. So thank you to you, Jimmy, and thank you to SCRS for this great opportunity.

Jimmy Bechtel: 26:05

You're very welcome, Lestter. As we wrap up, don't forget to explore more site focused resources on our website, myscrs.org. You'll find a wealth of content and publications, like the one we mentioned here today, plus the opportunity to save your spot for upcoming webinars and SCRS summits being held throughout the year. Thank you for tuning in, and we can't wait to have you back for more enriching content. Until next time.