Digital Clinical Registry Webinar Alert: Meet our Speakers and Find out why you should Attend this power session

Navitas Clinical Research (a part of Navitas Life Sciences) and OpenClinica will present a webinar titled “Digital registry platforms - Considerations for EHR/EDC Integration” on Thursday, 23 June 2022 between 10:00 a.m and 11:00 a.m. EST.

Navitas Clinical Research has over 30 years of experience and have supported several US Federal Agencies, including 10 National Institute of Health (NIH) Institutes, The Centers for Disease Control and Prevention (CDC), and The United States Department of Defense (DoD) for almost four decades with the coordination of hundreds of clinical trials and epidemiological studies covering a wide variety of therapeutic areas.

Navitas Clinical Research’s Comprehensive Registry Design and Implementation Support

• Common Data Element (CDE) and metadata driven Registry eSolution implementation
• Development of Pilot Registry with core and focused data elements and data sets
• Creation of data collection forms
• Development of patient reported outcomes module

There is still time to register your place and join our team of subject matter experts as they look at the art and science of registry platforms and explore key considerations relating to:

• What goes into Registry platform planning - delivered by Dr.Yun Lu, PhD, Vice President and Chief Science and Innovation Officer, Navitas Clinical Research
• How EHR - EDC integration can accelerate your registry study- delivered by Cal Collins, CEO and Co-Founder, OpenClinica
• How to obtain Optimized Digital Solutions through the data coordinating center – delivered by Andra Matthews, Senior Clinical Project Manager, Navitas Clinical Research

We met with Dr.Yun Lu, Cal Collins and Andra Matthews to find out more about their expertise and to gain some pre-event insights about registry planning and EHR-EDC integration. Read on to find out more.

Tell us more about yourself

As Vice President and Chief Science and Innovation Officer for Navitas Clinical Research (a part of Navitas Life Sciences), I direct, manage, and coach in Navitas Clinical Research’s cross-functional clinical research science, clinical data and standards, biostatistics, and bioinformatics, as well as technology for innovation.

As an integral member of the Navitas Clinical Research Executive and Senior Leadership Team, I actively participate in Project Governance, Financial Management/Outcomes, Staffing Planning/Allocations, and Business Development leadership/assistance. I have over 20 years of clinical data experience and I am responsible for the overall global development efforts of the Clinical Data Science and eSolution team. I lead efforts to incorporate CDISC into the electronic data capture system, submission to the USFDA, and development of therapeutic/disease-specific Common Data Elements.

Dr.Yun Lu, PhD

VP & NCR Chief Science and Innovation Officer,

Navitas Clinical Research

I received my Bachelor of Science degree from NanKai University, China and, subsequently, my Ph.D. in
Biophysics/Biochemistry from the Medical College of Ohio in 1996. I was a postdoctoral researcher at the University of Pennsylvania School of Medicine from 1997 to 1998 and was a postdoctoral fellow at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institute of Health (NIH) from 1999 to 2000.

Why is a disease registry important?

Disease registries are also known as Patient registries, Clinical Data Registries, etc. Disease registries are observational, based on Real-World Evidence (RWE), and use patients' data from standard care, patient-reported outcomes, medical history, and other information. The purpose and benefit of implementing a registry program is to characterize disease and progress, define patient population and sub-populations, and examine the use of certain approved drugs or medical devices.

A registry can provide valuable insights for use in future clinical trial design, patient recruitment, care cost, and policy decisions.

What expertise is required for registry planning?

The registry coordinating center needs in-depth experience and expertise to support the registry design and objectives, lead operation and regulatory activities, give valuable data to the patients, support patient education and self-management, and support ongoing and future clinical research and health care.

What could go wrong during registry planning?

Many organizations rush to start a registry program without enough strategic planning and careful evaluation. There are several common pitfalls that should be avoided when planning a registry program, including:

• No clearly defined purpose and goals for a registry program
• Planning a registry program without scientific rigor to inform the registry development
• Limited registry stakeholder consideration and lack of registry community consideration
• Underestimating the operation skills required to plan and implement a registry program
• Underestimating the complexity of the registry data sources

Tell us more about yourself?

I’m Cal Collins, the CEO and Co-Founder at OpenClinica. Our vision is to drive the future of digital clinical trials with innovative technology and more seamless integration with the healthcare system. I have co-led a collaboration with an OpenClinica client and the FDA that won Bio-IT World’s 2022 Innovative Practice Awards for their work on the OneSource initiative integrating EHR and EDC systems. Having been active in standards development work for many years, including as a member of CDISC’s Operational Data Model V2 feature team and the HL7 Vulcan Advisory Council, I’m grateful and humbled to see our work recognized and, more importantly, to witness the impact that it has on clinical research.

I am a graduate of Harvard University and have been featured in publications such as Clinical Research News, Medhealth Outlook, Bioinformatics, ACM/IEEE, and Clinical Leader. I have keynoted, presented, and/or organized sessions at events including the DIA Annual Meeting, SCDM Annual Conference, Society for Clinical Trials, American Medical Informatics Association’s Annual Symposium, the Open Source Electronic Health Records Alliance (OSEHRA) and the tranSMART Annual Meeting. I also sit on the board of Isovera, LLC, a digital agency.

Cal Collins

CEO and Co-Founder,

OpenClinica

Why is Electronic Health Record (EHR) and Electronic Data Capture (EDC) integration important for
a registry study?

EDC systems are typically used in registry studies for reporting and data capture purposes. However, a lot of that data already exists in the EHR, so by integrating and automating EHR data into the EDC, we remove the burden from patients, data managers, principal investigators, and other clinical trial stakeholders. As physicians and clinicians collect more data, it can be entered into their electronic health records (EHR), which are then easily populated into the EDC to contribute real-world data for clinical research around specific diseases and disorders. For registry studies specifically, having bulk data at our fingertips makes a difference, mainly because it removes the burden of manually transcribing all of that data.

How does EHR-EDC integration help improve efficiency?

Interoperability between the EHR and EDC improves efficiency in so many ways. OpenClinica Unite is an EHR eSource solution that enables clinical researchers to pull data from the EHR into the EDC with one click. In one example, the data shows that this process took a clinical research coordinator 60 minutes to transcribe from one system to another using traditional methods requiring manual transcription. We were able to reduce the time spent on data migration to 5 minutes, saving the clinical research team hundreds of hours over the lifespan of a clinical trial.

How does EHR integration work?

The Basics: In our case, OpenClinica Unite can be easily launched by clinicians, investigators, and clinical research coordinators from within the patient’s chart in the EHR. This functionality removes the need to separately log into research applications. OpenClinica Unite also provides summaries, trends, and visualizations of key information in ways that enhance safety and data quality while also supporting clinical care. Available in both a desktop and mobile version, OpenClinica Unite allows users to safely, accurately, and efficiently view study data where and when it is most needed.

Site Implementation, Integration, and Standardization: OpenClinica Unite is a secure, standards-based technology that is widely accepted by health system IT departments and backed by major EHR vendors. With no software to install, implementation is lightweight and fast. Once implemented at the site, OpenClinica Unite is immediately reusable across multiple trials and sponsors thanks to its scalable design. Lastly, not all sites need to use OpenClinica Unite. It fully supports hybrid models where select sites can be enabled.

Regulatory Compliance with Automated EHR eSource Data Capture: OpenClinica Unite greatly reduces the burden of capturing regulatory-grade, structured data for participating clinical trial sites. Built with rigorous compliance in mind, OpenClinica Unite is 21 CFR Part 11 and ICH GCP compliant. Traceability to the source is also built into the solution, capturing data originator and data element identifiers per FDA 2018 EHR guidance.

Tell us more about yourself

As a Senior Clinical Project Manager for Navitas Clinical Research, I am an authority in the area of regional and global project management. As an essential member of the Navitas Clinical Research Senior Project Management Team, I ensure projects are completed within scope by taking an active role in financial management, risk analysis, and business development. I have over 15+ years of clinical trial experience and am responsible for projects from study start-up to study closeout. I lead efforts to assist with developing and delivering presentations to prospective clients, ensuring the development and management of internal teams, and supporting negotiations of contracts and proposals resulting in final contract execution.

I have held several positions within the field of research ranging from Clinical Research Coordinator to Senior Level Project Manager. As a result, I understand the level of oversite, expertise, and intense coordination it takes to run registries and clinical trials.

Andra Matthews

Senior Clinical Project Manager,

Navitas Clinical Research

What is the importance of a data coordination center?

The data coordination center, also known as the DCC, is vital because it provides oversite for registries and clinical trials from start to finish. The DCC is the master repository for all study data. A successful data coordination center should take data collected from clinical research, healthcare, and other sources and turn it into useful aggregated information that will provide insights to the foundations, patients, and other stakeholders.

What is the significance of Optimized Digital Solutions?

Optimized digital solutions can support providers with registry coordination by automating tasks that will eliminate human error and improve overall disease registry and study productivity. The benefit is that optimized digital solutions will allow real-world evidence to be obtained and integrated with research data faster to develop new disease management insights.

Can you give us examples of how and where such applications help in a registry study?

Examples of how and where optimized digital solutions would be helpful in a registry include trial design, data aggregation, and analysis to support patient treatment and new drug development, site management, patient-facing dashboards, data sharing, and publications for better research and care.

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