WEBVTT
00:00:05.030 --> 00:00:06.519
Welcome to SCRS Talks.
00:00:06.519 --> 00:00:11.490
I'm Lauren Stockwell, Associate Director of Education and Engagement at SCRS.
00:00:11.490 --> 00:00:24.629
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.
00:00:24.629 --> 00:00:32.679
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.
00:00:32.679 --> 00:00:34.509
Dave, Amy, welcome.
00:00:34.850 --> 00:00:35.710
Hello, everyone.
00:00:35.710 --> 00:00:50.173
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.
00:00:50.274 --> 00:00:50.853
Thanks, Dave.
00:00:50.853 --> 00:01:06.712
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.
00:01:06.953 --> 00:01:12.584
and that work, Amy, is very much aligned with J&J's broader ambition.
00:01:12.584 --> 00:01:24.313
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.
00:01:24.313 --> 00:01:31.134
Because improving how research operates is essential to accelerating innovation for patients.
00:01:31.233 --> 00:01:35.534
Amy, I'd love to know what excites you most about EHR to sponsor?
00:01:35.662 --> 00:01:39.459
Technology Can be a disruptive innovation when it's implemented well.
00:01:39.459 --> 00:01:42.061
And I recognize that technology is a broad term.
00:01:42.061 --> 00:01:43.590
It can mean many different things.
00:01:43.590 --> 00:01:50.641
From my perspective, this is a clear opportunity to make clinical research easier for site teams to navigate.
00:01:50.641 --> 00:02:02.618
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.
00:02:02.618 --> 00:02:05.019
and in that scenario, everyone benefits.
00:02:05.019 --> 00:02:11.558
eHR to Sponsor is a solution that sites, sponsors, and the broader research community can all get behind.
00:02:11.658 --> 00:02:12.618
That's wonderful.
00:02:12.618 --> 00:02:19.288
Let's talk about the power of eHR to Sponsor from the beginning, starting with why eHR to Sponsor matters.
00:02:19.288 --> 00:02:25.538
Amy, can you share the data that supports eHR to Sponsor as a solution rather than just a change?
00:02:25.687 --> 00:02:30.949
What We consistently hear from sites is the need to reduce the duplicative manual data entry.
00:02:30.949 --> 00:02:40.157
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.
00:02:40.157 --> 00:02:51.439
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.
00:02:51.439 --> 00:03:11.575
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.
00:03:11.575 --> 00:03:17.816
That is a significant burden, and it takes time away from patient care and study execution.
00:03:17.816 --> 00:03:29.348
With eSource, we're seeing data accurately exchanged at 99.9%, which significantly reduces queries and improves confidence in the data
00:03:29.397 --> 00:03:35.388
And those metrics are impressive, Amy, but this is not just an operational inconvenience.
00:03:35.388 --> 00:03:44.367
It's actually an opportunity for improvement to how we support our site partners in the way that our studies are being executed.
00:03:44.367 --> 00:03:53.668
It has real implications for study quality, speed, the sustainability of our workforce, and really the overall research experience.
00:03:53.668 --> 00:04:02.747
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.
00:04:02.747 --> 00:04:11.788
And EHR to sponsor reflects that commitment to solving meaningful problems in ways that can improve research at scale.
00:04:11.888 --> 00:04:12.788
Absolutely.
00:04:12.788 --> 00:04:16.858
I have heard you say innovation without implementation is just an idea.
00:04:16.858 --> 00:04:23.687
In this world of competing priorities, how do you take something from an interesting innovation to standard practice?
00:04:23.687 --> 00:04:26.117
And can you walk us through what that journey looked like?
00:04:26.218 --> 00:04:27.247
Absolutely, Lauren.
00:04:27.247 --> 00:04:29.528
Collaboration is essential.
00:04:29.528 --> 00:04:37.468
Duplicative data entry is a socio-technical challenge, and solving it requires the full research community to move together.
00:04:37.468 --> 00:04:45.148
That's regulators, technology vendors, sites, consortiums, standards organizations, patients, and sponsors.
00:04:45.148 --> 00:04:51.350
When the entire community is aligned and moving in the same direction meaningful progress becomes possible.
00:04:51.350 --> 00:05:01.064
The data supports the business case, the technology solutions are available, and together we can drive the change management needed to make adoption real.
00:05:01.064 --> 00:05:19.848
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.
00:05:19.947 --> 00:05:23.458
So let's dive a little bit deeper into adoption.
00:05:23.458 --> 00:05:30.267
Not all sites' technical systems operate the same way, so how do we ensure that this will work for all sites?
00:05:30.367 --> 00:05:32.247
Lauren, such an excellent question.
00:05:32.247 --> 00:05:47.637
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.
00:05:47.637 --> 00:05:56.247
And this is so critical, 'cause we're always gonna have multiple vendors, but the architecture at the baseline needs to be interoperable.
00:05:56.247 --> 00:06:03.127
Otherwise, one-off solutions will risk upsetting the balance of benefits for both the site and the sponsor.
00:06:03.127 --> 00:06:12.338
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.
00:06:12.437 --> 00:06:16.437
So let's pause there and talk a little bit about those early adopters.
00:06:16.437 --> 00:06:18.887
A lot of focus has been on oncology.
00:06:18.887 --> 00:06:23.117
Why is that, and what is the path to all studies being e-sourced?
00:06:23.218 --> 00:06:31.747
Yes, oncology was a natural place to start because it has the highest volume of local labs, meaning labs conducted directly at the site.
00:06:31.747 --> 00:06:43.290
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.
00:06:43.290 --> 00:06:45.379
That made oncology a strong fit.
00:06:45.379 --> 00:06:52.410
J&J is now expanding the data we collect to include medical history, medications, procedures, and adverse events.
00:06:52.410 --> 00:07:02.958
And as that data becomes available, the percentage of the ECRF naturally increases, which creates a greater value across other therapeutic areas as well.
00:07:02.958 --> 00:07:09.598
Looking ahead, J&J is ramping up in twenty twenty-seven to expand this work across other therapeutic areas.
00:07:09.697 --> 00:07:12.908
And can you tell me in practical terms what that means for a site?
00:07:13.007 --> 00:07:20.788
Yeah, Lauren, I would say in practical terms, it really means maximizing the use of eSource for as many studies as possible.
00:07:20.788 --> 00:07:37.588
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
00:07:37.687 --> 00:07:41.517
At J&J, this is an important part of how we think about innovation.
00:07:41.517 --> 00:07:50.057
Not just what is technically possible, but what meaningfully improves the clinical research experience for sites and patients.
00:07:50.158 --> 00:07:56.127
So what insight into site needs can help drive the adoption of EHR to sponsor for all?
00:07:56.228 --> 00:07:58.810
The ask is for continued collaboration.
00:07:58.810 --> 00:08:06.930
Sites, geographical regions, regulations, and systems vary, and therefore, we recognize there is much more for us to learn.
00:08:06.930 --> 00:08:15.050
Collaborating with our sites on clinical research informatics projects, and EHR sponsor specifically, is integral to success.
00:08:15.149 --> 00:08:16.930
Yeah, I completely agree.
00:08:16.930 --> 00:08:23.920
So to begin to wrap us up, when people hear EHR to sponsor, what do you most want them to understand?
00:08:24.019 --> 00:08:30.019
Lauren I want people to understand that EHR to sponsor is about more than technology.
00:08:30.019 --> 00:08:45.269
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.
00:08:45.269 --> 00:08:58.889
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.
00:08:58.990 --> 00:08:59.730
I love that.
00:08:59.730 --> 00:09:07.259
And finally, as SCRS is all about key takeaways and creating follow-up, how do we continue this discussion?
00:09:07.259 --> 00:09:12.730
Where does it go next, and how can sites and other organizations listening follow up to learn more?
00:09:12.779 --> 00:09:20.690
First, we really appreciate the SCRS Global Summit for giving us the opportunity to have this important conversation with the site community.
00:09:20.690 --> 00:09:28.309
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.
00:09:28.309 --> 00:09:38.969
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.
00:09:39.097 --> 00:09:42.418
Amazing Dave, Amy, thank you both so very much.
00:09:42.418 --> 00:09:49.688
At SCRS, our entire mission is built around making sure the site perspective is at the center of conversations like this one.
00:09:49.688 --> 00:09:52.399
So we're so grateful that J&J brought this here.
00:09:52.399 --> 00:09:56.859
For our listeners, if this conversation resonated, share it with your network.
00:09:56.859 --> 00:10:01.058
The more awareness there is around what's possible, the faster we get there.
00:10:01.058 --> 00:10:03.578
Thank you for listening to SCRS Talks.
00:10:03.678 --> 00:10:08.668
And Lauren, thank you for the opportunity to connect with you, and thank you to everybody listening.
00:10:08.668 --> 00:10:23.889
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
00:10:23.989 --> 00:10:24.859
Thanks everyone.
00:10:24.859 --> 00:10:36.580
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.
00:00:05.030 --> 00:00:06.519
Welcome to SCRS Talks.
00:00:06.519 --> 00:00:11.490
I'm Lauren Stockwell, Associate Director of Education and Engagement at SCRS.
00:00:11.490 --> 00:00:24.629
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.
00:00:24.629 --> 00:00:32.679
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.
00:00:32.679 --> 00:00:34.509
Dave, Amy, welcome.
00:00:34.850 --> 00:00:35.710
Hello, everyone.
00:00:35.710 --> 00:00:50.173
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.
00:00:50.274 --> 00:00:50.853
Thanks, Dave.
00:00:50.853 --> 00:01:06.712
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.
00:01:06.953 --> 00:01:12.584
and that work, Amy, is very much aligned with J&J's broader ambition.
00:01:12.584 --> 00:01:24.313
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.
00:01:24.313 --> 00:01:31.134
Because improving how research operates is essential to accelerating innovation for patients.
00:01:31.233 --> 00:01:35.534
Amy, I'd love to know what excites you most about EHR to sponsor?
00:01:35.662 --> 00:01:39.459
Technology Can be a disruptive innovation when it's implemented well.
00:01:39.459 --> 00:01:42.061
And I recognize that technology is a broad term.
00:01:42.061 --> 00:01:43.590
It can mean many different things.
00:01:43.590 --> 00:01:50.641
From my perspective, this is a clear opportunity to make clinical research easier for site teams to navigate.
00:01:50.641 --> 00:02:02.618
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.
00:02:02.618 --> 00:02:05.019
and in that scenario, everyone benefits.
00:02:05.019 --> 00:02:11.558
eHR to Sponsor is a solution that sites, sponsors, and the broader research community can all get behind.
00:02:11.658 --> 00:02:12.618
That's wonderful.
00:02:12.618 --> 00:02:19.288
Let's talk about the power of eHR to Sponsor from the beginning, starting with why eHR to Sponsor matters.
00:02:19.288 --> 00:02:25.538
Amy, can you share the data that supports eHR to Sponsor as a solution rather than just a change?
00:02:25.687 --> 00:02:30.949
What We consistently hear from sites is the need to reduce the duplicative manual data entry.
00:02:30.949 --> 00:02:40.157
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.
00:02:40.157 --> 00:02:51.439
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.
00:02:51.439 --> 00:03:11.575
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.
00:03:11.575 --> 00:03:17.816
That is a significant burden, and it takes time away from patient care and study execution.
00:03:17.816 --> 00:03:29.348
With eSource, we're seeing data accurately exchanged at 99.9%, which significantly reduces queries and improves confidence in the data
00:03:29.397 --> 00:03:35.388
And those metrics are impressive, Amy, but this is not just an operational inconvenience.
00:03:35.388 --> 00:03:44.367
It's actually an opportunity for improvement to how we support our site partners in the way that our studies are being executed.
00:03:44.367 --> 00:03:53.668
It has real implications for study quality, speed, the sustainability of our workforce, and really the overall research experience.
00:03:53.668 --> 00:04:02.747
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.
00:04:02.747 --> 00:04:11.788
And EHR to sponsor reflects that commitment to solving meaningful problems in ways that can improve research at scale.
00:04:11.888 --> 00:04:12.788
Absolutely.
00:04:12.788 --> 00:04:16.858
I have heard you say innovation without implementation is just an idea.
00:04:16.858 --> 00:04:23.687
In this world of competing priorities, how do you take something from an interesting innovation to standard practice?
00:04:23.687 --> 00:04:26.117
And can you walk us through what that journey looked like?
00:04:26.218 --> 00:04:27.247
Absolutely, Lauren.
00:04:27.247 --> 00:04:29.528
Collaboration is essential.
00:04:29.528 --> 00:04:37.468
Duplicative data entry is a socio-technical challenge, and solving it requires the full research community to move together.
00:04:37.468 --> 00:04:45.148
That's regulators, technology vendors, sites, consortiums, standards organizations, patients, and sponsors.
00:04:45.148 --> 00:04:51.350
When the entire community is aligned and moving in the same direction meaningful progress becomes possible.
00:04:51.350 --> 00:05:01.064
The data supports the business case, the technology solutions are available, and together we can drive the change management needed to make adoption real.
00:05:01.064 --> 00:05:19.848
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.
00:05:19.947 --> 00:05:23.458
So let's dive a little bit deeper into adoption.
00:05:23.458 --> 00:05:30.267
Not all sites' technical systems operate the same way, so how do we ensure that this will work for all sites?
00:05:30.367 --> 00:05:32.247
Lauren, such an excellent question.
00:05:32.247 --> 00:05:47.637
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.
00:05:47.637 --> 00:05:56.247
And this is so critical, 'cause we're always gonna have multiple vendors, but the architecture at the baseline needs to be interoperable.
00:05:56.247 --> 00:06:03.127
Otherwise, one-off solutions will risk upsetting the balance of benefits for both the site and the sponsor.
00:06:03.127 --> 00:06:12.338
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.
00:06:12.437 --> 00:06:16.437
So let's pause there and talk a little bit about those early adopters.
00:06:16.437 --> 00:06:18.887
A lot of focus has been on oncology.
00:06:18.887 --> 00:06:23.117
Why is that, and what is the path to all studies being e-sourced?
00:06:23.218 --> 00:06:31.747
Yes, oncology was a natural place to start because it has the highest volume of local labs, meaning labs conducted directly at the site.
00:06:31.747 --> 00:06:43.290
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.
00:06:43.290 --> 00:06:45.379
That made oncology a strong fit.
00:06:45.379 --> 00:06:52.410
J&J is now expanding the data we collect to include medical history, medications, procedures, and adverse events.
00:06:52.410 --> 00:07:02.958
And as that data becomes available, the percentage of the ECRF naturally increases, which creates a greater value across other therapeutic areas as well.
00:07:02.958 --> 00:07:09.598
Looking ahead, J&J is ramping up in twenty twenty-seven to expand this work across other therapeutic areas.
00:07:09.697 --> 00:07:12.908
And can you tell me in practical terms what that means for a site?
00:07:13.007 --> 00:07:20.788
Yeah, Lauren, I would say in practical terms, it really means maximizing the use of eSource for as many studies as possible.
00:07:20.788 --> 00:07:37.588
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
00:07:37.687 --> 00:07:41.517
At J&J, this is an important part of how we think about innovation.
00:07:41.517 --> 00:07:50.057
Not just what is technically possible, but what meaningfully improves the clinical research experience for sites and patients.
00:07:50.158 --> 00:07:56.127
So what insight into site needs can help drive the adoption of EHR to sponsor for all?
00:07:56.228 --> 00:07:58.810
The ask is for continued collaboration.
00:07:58.810 --> 00:08:06.930
Sites, geographical regions, regulations, and systems vary, and therefore, we recognize there is much more for us to learn.
00:08:06.930 --> 00:08:15.050
Collaborating with our sites on clinical research informatics projects, and EHR sponsor specifically, is integral to success.
00:08:15.149 --> 00:08:16.930
Yeah, I completely agree.
00:08:16.930 --> 00:08:23.920
So to begin to wrap us up, when people hear EHR to sponsor, what do you most want them to understand?
00:08:24.019 --> 00:08:30.019
Lauren I want people to understand that EHR to sponsor is about more than technology.
00:08:30.019 --> 00:08:45.269
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.
00:08:45.269 --> 00:08:58.889
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.
00:08:58.990 --> 00:08:59.730
I love that.
00:08:59.730 --> 00:09:07.259
And finally, as SCRS is all about key takeaways and creating follow-up, how do we continue this discussion?
00:09:07.259 --> 00:09:12.730
Where does it go next, and how can sites and other organizations listening follow up to learn more?
00:09:12.779 --> 00:09:20.690
First, we really appreciate the SCRS Global Summit for giving us the opportunity to have this important conversation with the site community.
00:09:20.690 --> 00:09:28.309
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.
00:09:28.309 --> 00:09:38.969
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.
00:09:39.097 --> 00:09:42.418
Amazing Dave, Amy, thank you both so very much.
00:09:42.418 --> 00:09:49.688
At SCRS, our entire mission is built around making sure the site perspective is at the center of conversations like this one.
00:09:49.688 --> 00:09:52.399
So we're so grateful that J&J brought this here.
00:09:52.399 --> 00:09:56.859
For our listeners, if this conversation resonated, share it with your network.
00:09:56.859 --> 00:10:01.058
The more awareness there is around what's possible, the faster we get there.
00:10:01.058 --> 00:10:03.578
Thank you for listening to SCRS Talks.
00:10:03.678 --> 00:10:08.668
And Lauren, thank you for the opportunity to connect with you, and thank you to everybody listening.
00:10:08.668 --> 00:10:23.889
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
00:10:23.989 --> 00:10:24.859
Thanks everyone.
00:10:24.859 --> 00:10:36.580
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.
