Risk Based Monitoring: New Thinking on Clinical Oversight

Since the FDA and EMA published their current thinking on clinical oversight and risk-based monitoring (RBM) strategies, the topic has received a magnitude of attention, commanding column inches, webinar discussions and industry conferences. With so much discussion going on, it is unsurprising that many sponsors are feeling out in the cold when it comes to identifying how to practically implement RBM strategies within study designs. As data quality matters most in determining study success and ensuring patient safety, the latest recommendations have created growing demand for solutions that simplify the transition to risk-based techniques.

In this program, our guests discuss how emerging technologies and Central Statistical Monitoring (CSM) now present more practical means of implementing successful RBM strategies. Both Sanofi and Novartis will provide a large pharma perspective on making the move to RBM.

Host: Valerie Bowling, Executive Director, The Conference Forum

Guests:

Marc Buyse, Founder, International Drug Development Institute & CluePoints

Eric Genevois-Marlin, VP, Biostatistics & Programming, Sanofi

Thomas Haag, Data Integrity Process Expert, eClinical Quality Assurance, Novartis Pharmaceuticals