Beyond the EHR: Clinical Trials in the Age of Abundant Data

Life Sciences, Clinical Trials, Healthcare,
  • Friday, September 30, 2022

An electronic health record (EHR) is ubiquitous. Healthcare data is growing exponentially but thanks to outdated regulations and firmly rooted traditions, the clinical research industry has yet to fully wrangle such information to advance new medicines, therapies and products.

Data partnerships serve as an exciting solution to overcoming the barriers that stand between clinical trials and the advancements EHR data promises. But how do partnerships leverage data to accelerate research? What advanced trial designs will such partnerships make possible? And what challenges stand in the way of forming partnerships to access EHR data for research purposes?

Featuring industry leaders, the webinar will explore how data partnerships can advance research, including data-driven, real-world inspired protocols that increase patient-centricity, recruitment and retention. The speakers will also explore using artificial intelligence (AI) to retrieve medical records to avoid poor recollection and “hearsay.” They will detail trial designs that such EHR-based advances will make possible, from diagnostic trials to rapid patient ID at scale. Finally, the speakers will discuss what challenges remain in using EHR in research, such as the lack of templates for data partnerships, regulatory considerations and the need to streamline and focus protocol development.

Join this webinar for expert insights and engaging discussion surrounding the utilization of EHR data in clinical research and what the future might hold. 



Michael Ibara, PharmD, Chief Data Officer, Elligo Health Research®

Michael Ibara has more than 20 years of experience in clinical research and development. Throughout his career, Ibara has sought to improve healthcare by bringing together healthcare data and digital technologies. His interests include regulatory and policy implications for digital healthcare, exploring the factors needed to allow interoperability of healthcare data for all stakeholders involved and implications for the use of big data, machine learning and natural language processing to improve our ability to perform regulated clinical research.

Before joining Elligo, Ibara was the Head of Digital Healthcare for the Clinical Data Interchange Standards Consortium (CDISC). There, he led the US Food and Drug Administration (FDA) eSource project and Healthcare Link efforts with registries, clinical trials and mobile health to enable use of real-world data from healthcare for regulated research and decision making. Prior to CDISC, Ibara was Head of Business Development Coordination and Innovation and also Head of Pharmacovigilance Innovation at Pfizer, where he worked for 15 years in various positions, leading implementations of global systems and large-scale technologies.

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Michael R. Fronstin, Global Head of Clinical Research and Consulting, Cerner Enviza

Michael joined the organization in 2005 and currently leads the Clinical, Regulatory and Safety team at Cerner Enviza formerly Kantar Health. Michael’s team is responsible for delivering high quality, regulatory grade work to support pre/peri approval clinical research and post approval safety surveillance. The Clinical, Regulatory and Safety team also leads the global Harm Reduction partnerships and separately, Public Health partnerships in Germany. In addition to overseeing the global team, Michael’s accountable for supporting corporate development and product innovation.

Michael’s prior roles include Global Head of Offer and Innovation, General Manager of the Real-World Evidence Group, Chief Operating Officer and Head of Lifesciences Business Development. As a result, Michael brings broad and deep experience related to global clients, P/L portfolio management and operations.

He has broad experience in the healthcare industry. Prior to joining Cerner Enviza, he held various leadership roles spanning industry, payor and consulting organizations.

Michael is a member of the Cerner Enviza Leadership Team and is proud to serve as a board member for International Gardian Limited.

Michael earned a Master of Business Administration from the University of Miami with a certification in healthcare administration. He has a bachelor’s degree in sociology from the State University of New York at Albany.

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Seth Hopkins, PhD, Executive Director Translational Medicine, Sunovion Pharmaceuticals Inc.

Seth Hopkins, PhD, is Executive Director Translational Medicine at Sunovion Pharmaceuticals Inc. In his work at Sunovion, he has led and advanced new treatments for CNS disorders from discovery through to regulatory submissions. Prior to his role in translational medicine, Seth has served in a variety of roles including computational chemistry, pharmacology, preclinical and clinical development. During his tenure, he has  advanced programs through clinical development applying clinical pharmacology, experimental medicine, neuroimaging, modeling and simulations. At Sunovion his current research interest is in the application of advanced mathematics and analytics to improve the efficiency of clinical development of breakthrough treatments for psychiatric disorders. Seth was a key contributor to the initiation, clinical development and submission of INDs and NDAs in psychiatric indications.

Seth completed his postdoctoral training at University of California San Francisco and his PhD in biophysics from the University of Pennsylvania.

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Doug Lee, Vice President, Operations and Chief Data Officer, Harris Computer

With over 20 years’ experience in business, technology and innovation leadership, Doug Lee has emerged as a change agent. Through precise strategy and dynamic culture development, Doug has demonstrated the ability to help businesses weaponize their data to drive top line growth and profitability.

In his role as Vice President, Operations and Chief Data Officer, Doug is responsible for data strategy, data commercialization, innovation and operational excellence.  He is active in related professional organizations, serving on various boards within the private and public sectors.

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Who Should Attend?

The webinar will be of interest to members of the following industries:

  • Pharma, Biotech, Medical Device
  • CROs

Relevant areas:

  • Clinical operations
  • Medical affairs
  • Innovation

What You Will Learn

  • What the right data partnerships can accomplish, from patient-centric protocols to artificial intelligence (AI)-run medical record retrieval
  • What trial designs data partnerships will enable
  • What challenges still exist in harnessing electronic health record (EHR) data for use in clinical trials
  • Possible strategies for overcoming such challenges and opening an exciting new world of research

Xtalks Partner

Elligo Health Research

Elligo Health Research accelerates clinical trials through healthcare with access to over 150 million known patients and their HIPAA-compliant healthcare data, our IntElligo® Research Stack technology, and our PatientSelect identification and engagement model. Coupled with the largest Known Patient Access Network, Elligo’s Site Solutions enable healthcare practices and research sites to participate in clinical trials. By adaptive engagement of known patients and physicians, we accelerate the development of new pharmaceutical, biotechnology, and medical device and diagnostic products.

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