Simplify the Work; Lead the Science: EHR2Sponsor

In this episode of SCRS Talks, Lauren Stockwell sits down with Dave Damrau, VP of Global Clinical Operations for the Americas, and Amy Cramer, Global Head of eSource Data Acquisition, both from Johnson & Johnson Innovative Medicine, to unpack J&J's EHR to Sponsor initiative. They discuss why duplicative data entry remains one of the biggest burdens on site staff, what the data shows about the time and error costs of manual transcription, and how eSource solutions are already improving data accuracy. Dave and Amy walk through why oncology became the starting point for this work, what site-driven collaboration has meant for adoption, and what's next as J&J expands EHR to Sponsor into additional therapeutic areas in 2027. Tune in to hear how this initiative aims to reduce friction for sites while creating a more efficient, connected model for clinical research.

Join Dave and Amy for the J&J SCRS Summit EHR Action Panel on October 18th from 9:00 to 10:00 AM.

Transcript

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Lauren Stockwell 0:05

Welcome to SCRS Talks. I'm Lauren Stockwell, Associate Director of Education and Engagement at SCRS. And today, we're joined by two guests from Johnson Johnson Innovative Medicine, Dave Damrau, VP of Global Clinical Operations for the Americas, and Amy Kramer, Global Head of eSource Data Acquisition. We're diving into J&J's EHR to Sponsor initiative, what it means for sites, and why it matters for the future of clinical research. Dave, Amy, welcome.

Dave Damrau 0:34

Hello, everyone. I'm Dave Damrau, and today I am joined by my colleague Amy for a conversation about the EHR to sponsor approach by J&J Innovative Medicine and why it matters for the future of clinical research.

Amy Cramer 0:50

Thanks, Dave. this is an important topic because EHR to sponsor speaks directly to one of the biggest opportunities in research today, how we reduce burden on sites, improve the quality and timeliness of data, and create a more connected research ecosystem.

Dave Damrau 1:06

and that work, Amy, is very much aligned with J&J's broader ambition. At J&J, we're really focused on advancing clinical research in ways that are more patient-centered, more efficient for sites, and really better connected across the healthcare ecosystem. Because improving how research operates is essential to accelerating innovation for patients.

Lauren Stockwell 1:31

Amy, I'd love to know what excites you most about EHR to sponsor?

Amy Cramer 1:35

Technology Can be a disruptive innovation when it's implemented well. And I recognize that technology is a broad term. It can mean many different things. From my perspective, this is a clear opportunity to make clinical research easier for site teams to navigate. eHR to Sponsor is designed to alleviate operational burden wherever possible by reducing the need for site staff to transcribe data so they can focus on what matters most, the patient. and in that scenario, everyone benefits. eHR to Sponsor is a solution that sites, sponsors, and the broader research community can all get behind.

Lauren Stockwell 2:11

That's wonderful. Let's talk about the power of eHR to Sponsor from the beginning, starting with why eHR to Sponsor matters. Amy, can you share the data that supports eHR to Sponsor as a solution rather than just a change?

Amy Cramer 2:25

What We consistently hear from sites is the need to reduce the duplicative manual data entry. It is time-consuming, it introduces errors, and just as importantly, it keeps highly experienced research staff from working at the top of their ability. The literature supports that more than 50% of clinical trial data, and in some cases up to 70%, is duplicated between the EHR and research systems. In oncology specifically, eSourcing vital signs and labs alone represents approximately 33% of the data captured in the electronic case report form We also know from the literature that site staff can spend approximately three to five minutes per data point re-entering information. That is a significant burden, and it takes time away from patient care and study execution. With eSource, we're seeing data accurately exchanged at 99.9%, which significantly reduces queries and improves confidence in the data

Dave Damrau 3:29

And those metrics are impressive, Amy, but this is not just an operational inconvenience. It's actually an opportunity for improvement to how we support our site partners in the way that our studies are being executed. It has real implications for study quality, speed, the sustainability of our workforce, and really the overall research experience. And at J&J, we really see a clear need to help advance models that are more sustainable for sites, but also more scalable for the industry holistically. And EHR to sponsor reflects that commitment to solving meaningful problems in ways that can improve research at scale.

Lauren Stockwell 4:11

Absolutely. I have heard you say innovation without implementation is just an idea. In this world of competing priorities, how do you take something from an interesting innovation to standard practice? And can you walk us through what that journey looked like?

Amy Cramer 4:26

Absolutely, Lauren. Collaboration is essential. Duplicative data entry is a socio-technical challenge, and solving it requires the full research community to move together. That's regulators, technology vendors, sites, consortiums, standards organizations, patients, and sponsors. When the entire community is aligned and moving in the same direction meaningful progress becomes possible. The data supports the business case, the technology solutions are available, and together we can drive the change management needed to make adoption real. Direct open conversation about what is needed, what works, and where concerns remain are what builds that trust, and trust is what allows us to support one another through the journey and co-develop the solutions, both the technological, technical, and enabling processes.

Lauren Stockwell 5:19

So let's dive a little bit deeper into adoption. Not all sites' technical systems operate the same way, so how do we ensure that this will work for all sites?

Dave Damrau 5:30

Lauren, such an excellent question. And really to become a standard practice, the approach that we implement needs to be standards-based, systems-agnostic, and aligned to the business requirements of both the site as well as the sponsor. And this is so critical, 'cause we're always gonna have multiple vendors, but the architecture at the baseline needs to be interoperable. Otherwise, one-off solutions will risk upsetting the balance of benefits for both the site and the sponsor. So the real key here is listening to the technical needs of sites, and then using those lessons learned and best practices from those early adopters.

Lauren Stockwell 6:12

So let's pause there and talk a little bit about those early adopters. A lot of focus has been on oncology. Why is that, and what is the path to all studies being e-sourced?

Amy Cramer 6:23

Yes, oncology was a natural place to start because it has the highest volume of local labs, meaning labs conducted directly at the site. When we looked across the data volumes, the areas with the highest error rates, and the feedback from the sites on what takes the most time to enter, labs and vital signs clearly rose to the top. That made oncology a strong fit. J&J is now expanding the data we collect to include medical history, medications, procedures, and adverse events. And as that data becomes available, the percentage of the ECRF naturally increases, which creates a greater value across other therapeutic areas as well. Looking ahead, J&J is ramping up in twenty twenty-seven to expand this work across other therapeutic areas.

Lauren Stockwell 7:09

And can you tell me in practical terms what that means for a site?

Dave Damrau 7:13

Yeah, Lauren, I would say in practical terms, it really means maximizing the use of eSource for as many studies as possible. And what that will then do is reduce repetitive tasks, improve data consistency, and give sites more time for the activities that matter most, which we all know are patient engagement, clinical oversight, and real quality execution

Amy Cramer 7:37

At J&J, this is an important part of how we think about innovation. Not just what is technically possible, but what meaningfully improves the clinical research experience for sites and patients.

Lauren Stockwell 7:50

So what insight into site needs can help drive the adoption of EHR to sponsor for all?

Amy Cramer 7:56

The ask is for continued collaboration. Sites, geographical regions, regulations, and systems vary, and therefore, we recognize there is much more for us to learn. Collaborating with our sites on clinical research informatics projects, and EHR sponsor specifically, is integral to success.

Lauren Stockwell 8:15

Yeah, I completely agree. So to begin to wrap us up, when people hear EHR to sponsor, what do you most want them to understand?

Dave Damrau 8:24

Lauren I want people to understand that EHR to sponsor is about more than technology. It really is about reducing friction in clinical research, improving the connection between care and research, and really enabling a model that will be more efficient for sites and more dependable for sponsors. So it's really about helping the industry operate in a smarter, more integrated way so that we can accelerate the development of new medicines and really improve the experience of research for everyone involved.

Lauren Stockwell 8:58

I love that. And finally, as SCRS is all about key takeaways and creating follow-up, how do we continue this discussion? Where does it go next, and how can sites and other organizations listening follow up to learn more?

Amy Cramer 9:12

First, we really appreciate the SCRS Global Summit for giving us the opportunity to have this important conversation with the site community. We recognize there's still a lot more work to be done, and J&J's thrilled to be part of the solution in working with sites to be successful. So we invite you all to join us at the J&J SCRS Summit EHR Action Panel on October 18th from 9:00 to 10:00 AM.

Lauren Stockwell 9:39

Amazing Dave, Amy, thank you both so very much. At SCRS, our entire mission is built around making sure the site perspective is at the center of conversations like this one. So we're so grateful that J&J brought this here. For our listeners, if this conversation resonated, share it with your network. The more awareness there is around what's possible, the faster we get there. Thank you for listening to SCRS Talks.

Dave Damrau 10:03

And Lauren, thank you for the opportunity to connect with you, and thank you to everybody listening. We appreciate you joining us for this discussion on the J&J EHR to sponsor approach and all of the good work that's already underway so that we can help shape a much more connected and site-centered future for clinical research

Amy Cramer 10:23

Thanks everyone. Looking forward to meeting you and having great conversations at the SCRS Summit and J&J's EHR Action Panel on October 18th from 9:00 to 10:00 AM.