Bridging The Gap: EHR To EDC Integration In Clinical Trials - Reality Check

The promise of seamlessly mapping data directly from Electronic Health Record (EHR) systems to Electronic Data Capture (EDC) systems has captured the attention of clinical research professionals worldwide. On paper, the benefits are compelling: dramatically reduced on-site monitoring requirements, streamlined source data verification (SDV), enhanced data quality through elimination of manual transcription errors, and significant reduction in administrative burden on research sites. 

But, is direct EHR-to-EDC mapping the game-changer we've been waiting for, or will widespread implementation require a more nuanced understanding of site data collection practices and systems? Besides EHR solutions, industry-specific eSource solutions have become increasingly popular, and these solutions could complement, not supplant, the current effort to integrate EHR with EDC systems.

Join our distinguished panel of industry experts representing the critical perspectives of research sites, pharmaceutical sponsors, and Contract Research Organizations (CROs) for an engaging and honest discussion about the current state and future potential of EHR-to-EDC integration. The panelists will cover key questions, including:

• How much and what kind of research data is captured in the EHR?
• If it's not in the EHR, where is it?
• What other technology already in use by research sites could be leveraged to solve these same problems?
• What impact does the types of sites participating in a trial and the therapeutic area of the trial have?

Speakers:

Raymond Nomizu

Founder & Co-CEO, CRIO

Prior to co-founding CRIO, Raymond Nomizu owned and operated a clinical research site. As co-CEO he provides leadership for product development, engineering, and corporate strategy. He has over 10 years of management consulting experience, including The Boston Consulting Group. He also started Bench Core, a real estate data analytics company that was acquired by RefineRE. He began his career as an attorney and has JD and BA degrees from Harvard University.

Mike Ward

Senior Director, Clinical Trial Foundations, Eli Lilly & Company

Mike Ward, currently serving as Senior Director of Clinical Trial Foundations, has focused his 27-year career at Lilly on advancing clinical trial data collection within Lilly, and across the pharmaceutical industry. He is at the forefront of transforming clinical trial operations through digital enablement, with a particular focus on eSource adoption and EMR-to-EDC integration.

Mike leads strategic initiatives that leverage platforms such as CRIO to streamline source data capture and reduce site burden. He also partners closely with IgniteData and Veeva to advance seamless EMR-to-EDC interoperability, enabling real-time data flow and improving data quality across studies. His work accelerates trial timelines while enhancing regulatory compliance and patient-centricity.

In addition to his operational leadership, Mike has been an active driver to industry standards through various leadership with CDISC, HL7 and TransCelerate. He is now a sponsor advisor for i~HD’s eSource Scale-up Task Force whose mission is to “collectively drive and scale eSource implementation, revolutionizing the setup and execution of clinical trials worldwide.

Clare Campbell-Cooper

Global Head, Digital Health and Innovation, Fortrea

Clare Campbell-Cooper joined Fortrea in February 2020 and serves as its Global Head of Digital Health and Innovation. Clare has over 25 years of industry experience and is a recognized leader within the field of digital health. Clare has a wealth of experience encompassing many disciplines within clinical research and has held management positions within Data Management, Clinical Monitoring, Phase I Operations, Strategy and Planning, Project Management and, most recently, Digital Health.

Clare is an active member of a number of boards and associations and sees that working in a pre-competitive environment is critical to helping drive change within the industry. Clare is passionate about how we can change clinical trials for the better and is a member of the Fortrea Environmental Sustainability Committee and a founding member of the Fortrea Sustainable Future Chapter. Clare sits on the Kings College London Scientific Advisory Board, Centre for Pharmaceutical Medicine Research and is a visiting lecturer at KCL.

In her role as Global Head of Digital Health and Innovation at Fortrea Clare is helping to change the face of how clinical research is developing. She specialises in strategy development for both internal and external partners. Clare's special interest lies in the relationship between the caregiver and physician team and how the use of digital technology can augment this.

Brad Hightower

Owner, Hightower Clinical

Brad has worked at the site-level in clinical research for 15 years and is the former Executive Director of the Oklahoma Heart Hospital Research Foundation. Brad has since started his own integrated site network, Hightower Clinical, and co-hosts Note to File: A Clinical Research Podcast.

Mats Sundgren, PhD, MSc

Senior Industry Scientific Director and Co-Founder, European Institute for Innovation through Health Data

Mats Sundgren, PhD, MSc, is a distinguished authority in Health Data Strategy, serving both industry and academia. With an impressive career spanning over 37 years in the pharmaceutical industry, Mats has made significant contributions across various domains, including Discovery, Development, Manufacturing, IT R&D, Patents, Clinical Science, and Data Science & AI. His work places him at the forefront of technological innovation in the field.

In 2022, following an illustrious 12-year tenure as the global integration lead for Electronic Health Records (EHR) services at AstraZeneca, Mats expanded his professional endeavors. He now holds several key roles: Senior Industry Scientific Director and co-founder of the i~HD (European Institute for Innovation through Health Data), Executive Strategic Advisor for IgniteData, which develops a system-agnostic EHR-to-EDC solution for clinical trials, and Chairman of the Board of the Research Foundation IMIT (Institute of Managing Innovation and Technology). IMIT includes prominent institutions such as Chalmers University of Technology, Royal Institute of Technology, Lund University of Technology, and Stockholm School of Business. Additionally, he serves as a Board Member of the Center for Health Governance at Gothenburg University. In July 2024, Mats assumed the role of Scientific Adviser for IOMED, a company specializing in AI-powered technology for healthcare data activation. In March 2025, assumed the role of R&D Strategy Advisor for ZS Associates.

Mats has an extensive portfolio of work, including over 80 publications, books, and patents in Life Science, Economics, and Social Science. His areas of expertise encompass Health Data Science & AI, Clinical Science, Clinical Trials Management, Business Modelling, Innovation & Creativity Management, and Device Development.