eCOA Data and Regulatory Scrutiny: What You Should Know

While regulatory agencies worldwide clearly recognize the value of eSource data, inspection scrutiny has increased for a variety of reasons. Applying the same paper-driven logic to the digital world, regulators are more focused on data integrity than ever.

This webinar discussion will focus on areas of regulatory concern, the value of upfront collaborations between providers and sponsors to determine important data, along with suggested tools and tactics for sponsors to stay compliant when eCOA data are part of a clinical trial. Key learnings include:

• Areas of increased regulatory scrutiny
• How to ensure data integrity and inspection readiness
• Other considerations for proactive data review

Speakers

Steve Begley, Senior Vice President, Quality and Compliance, YPrime

Steve Begley serves as Senior Vice President, Quality and Compliance at YPrime.

As a seasoned quality assurance executive, he oversees the company’s global quality function, including quality control and assurance, regulatory compliance, process improvement, software development and delivery, and quality management systems.

Prior to joining YPrime in 2013, Steve managed global quality assurance and quality systems for Cenduit and ePharma Solutions. He began his career as a data coordinator for the University of Pennsylvania.

Steve attended the Wharton School of Business at the University of Pennsylvania.

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Colin Cleary, Vice President, Strategic Solutions, YPrime

As Vice President, Strategic Solutions, Colin focuses on development of global customer relationships and business development activity to identify ways that YPrime can serve its biopharmaceutical clients.

Colin is a recognized subject matter expert in eCOA technology, bringing more than 10 years of operational and strategic business experience.

His industry tenure has included positions as Director of Client Relations, Program Director and Manager for a global eClinical provider, where he oversaw global study programs, supervised project management teams and managed key account relationships.

Colin began his career as a project coordinator for asthma research programs at Thomas Jefferson University. He earned a master’s degree in public health from Dartmouth Medical School, and received a bachelor of science degree from Fairfield University.

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