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Adapting GCPs to Evolving Drug Development Paradigm (Part 2 of 2)
Session Chair(s)
Ann Meeker-O'Connell, MS
Executive Director, Monitoring Excellence Head, Novartis, United States
Emerging technologies have the potential to dramatically increase the efficiency and quality of clinical trials. Significant attention has been given to technology that may benefit both sponsor and investigator sites, such as electronic data capture (EDC) systems and eSource systems; these are technologies that may streamline data collection at the site-level, change data quality control paradigms, and provide sponsors with real-time insight into the accumulating data about an investigational product. This session will turn the focus to emerging technologies that may facilitate patient participation in clinical trials, such as electronic informed consent forms (eICF) and electronic patient reported outcome (ePRO) tools. FDA, industry, and patient advocate speakers will discuss the potential benefits of adopting patient-centric technology, the potential challenges in implementation, as well as compliance considerations in meeting applicable laws and regulations.
Part 1 will take place on Tuesday at 1:30 pm (Session #271).
Learning Objective : Discuss emerging technologies including the potential benefits of adopting patient-centric technology; Explain the potential challenges in implementation as well as compliance considerations in meeting applicable laws and regulations.
Speaker(s)
Sean Kassim, PHD
Director, Office of Study Integrity and Surveillance, OTS, CDER, FDA, United States
Regulatory Perspective
Coleen Glessner, MBA
Senior Vice President, Chief Quality Officer, Alexion Pharmaceuticals, United States
Industry Perspective
Marcia K. Horn, JD
President and CEO, ICAN, International Cancer Advocacy Network, United States
Patient Perspective
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