How Sponsors are Accelerating Clinical Trials with Automatic EHR Integration

All clinical studies face a common challenge — acquiring high quality data, efficiently. Getting data from its source into a finalized state is typically a laborious, time consuming and expensive process involving numerous parties. For sponsors, CROs and sites relying on traditional strategies, this complexity slows down every aspect from enrollment to market.

Can an automatic electronic health record (EHR) integration help?

Yes! The ability to extract relevant data from EHRs directly into the clinical trial database dramatically simplifies complex tasks such as:

• Participant enrollment
• Chart reviews
• Outcome tracking
• Data cleaning and verification

Automatic data integration lowers the work burden for sites, makes participation easier for subjects and delivers key data earlier to sponsors to accelerate data-driven decisions.

Register now to learn how sponsors, CROs and sites are using automatic EHR integration to advance the science of clinical trial research.

Speakers

Adam Asare, Chief Data Officer, QuantumLeap Healthcare Collaborative

Adam Asare has over 15 years’ experience in academic and industry developing clinical and research information systems. As the Quantum Leap Healthcare Collaborative Chief Data Officer and, jointly, Director of Information Technology for the UCSF Breast Care Clinic, he oversees efforts for process re-engineering and quality improvement of clinical trials, clinical care and research. Adam’s IT data management portfolio includes: I-SPY COVID and I-SPY 2 trials, the OneSource/eSource platform collaboration with the US Food and Drug Administration (FDA), the Clinical Trials Matching platform and the Athena Breast Health Network platform.

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Dr. Michael Hogarth, Chief Clinical Research Information Officer, UC San Diego Health

Dr. Michael Hogarth is a board-certified Internal Medicine physician and a faculty in biomedical informatics. He currently also serves as Chief Clinical Research Information Officer for UC San Diego Health. He is also engaged in several grant and contract funded activities. These include the California Electronic Death Registration System (California EDRS), the Maryland Death Registration System, the Athena Breast Health Network project (http://www.athenacarenetwork.org), the novel I-SPY2 adaptive breast cancer clinical trial, the pSCANNER clinical data research network (CDRN) and the California Precision Medicine Consortium (CaPMC). In 2015, he was elected to the American College of Medical Informatics (ACMI). Dr. Hogarth’s research interests include the development of next generation public health information systems, terminology/ontology infrastructure in biomedical informatics and developing systems that support clinical research at the point of care.

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Mike Keens, CRO Executive

Mike Keens has more than 20 years’ experience in clinical trial development, management, and commercial efforts across large global contract research organizations (CROs), small biotech, and health software. Mike is a subject matter expert in Hybrid/Decentralized Clinical Trials (DCT), and his efforts have been recognized by CenterWatch as a “Top 20 Innovator” (2018) and PharmaVoice as a “Top 100 Inspiring People in Pharma” (2020). In addition to serving as an evaluating judge for the recent 2022 UCSF Digital Health Awards, Mike also serves as an Operating Consultant in the health services space to Thompson Street Capital Partners.

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Cal Collins, CEO, OpenClinica

Cal co-founded OpenClinica with colleague Ben Baumann in 2006. He co-led a collaboration with an OpenClinica client and the US Food and Drug Administration (FDA) that won Bio-IT World’s 2022 Innovative Practice Awards for their work on the OneSource initiative integrating EHR and EDC systems. He has 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 and Steering Committee.

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Lynsey Bentley, Sr. Project Manager, OpenClinica

Lynsey is an experienced project manager whose career in clinical research first began at Epic Systems where she directed a large-scale implementation of the EpicCare Ambulatory EHR. She has overseen a large portfolio of projects ranging from community hospitals to large academic healthcare organizations during which she has regularly engaged with operational leads, subject matter experts, and executives in order to address complex workflows, regulatory, and compliance needs. Ms Bentley currently coordinates all aspects of OpenClincia’s product implementations and custom development projects. She is an integral member of the OC Unite development team, bringing her extensive experience to bear on the advancement of automatic EHR to EDC integration. Lynsey holds a BS with honors from Saint Joseph’s University.

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