Realizing the potential of Risk Based Monitoring (RBM) requires coordination and collaboration across functions within both the Sponsor and CRO organizations.
In this webinar, Dr. David Orloff and Dr. Alex Artyomenko explore the cross-functional perspectives and process alignment between Sponsor and CRO:
* Medical: influences on overall risk profile of the study, such as complexity of the design and challenges of specific indications
* Regulatory: navigating international regulatory landscape while applying the RBM principles
* Operational: taking a holistic approach to build a customized monitoring program
* Data management: new challenges for data collection, analysis and technology requirements
This webinar spotlights how drug sponsors can work with their CRO partners early in the research process to develop optimal monitoring strategies.
Dr. David Orloff, Sr. Vice President Regulatory and Medical Affairs at Medpace, has over 25 years of experience in clinical research and drug development. He is an endocrinologist and a past director of the Division of Metabolism and Endocrinology Products at the FDA where he accumulated 11 years of regulatory experience as a reviewer and division director. In addition, during nearly 20 years of association with NIH, he had extensive research experience in molecular and cellular biology, adult and pediatric clinical endocrinology, and lipid metabolism. He has been with Medpace for nearly ten years and brings his clinical research experience and regulatory insights to the discussion on RBM.
Dr. Alexander Artyomenko, Director, Late Phase Clinical Operations at Medpace, is a cardiologist and has over 12 years of experience in Late Phase clinical research. His unique background encompasses both medical practice and clinical research and development, with a highly successful record in planning and executing global Phase IIIb-IV studies in a variety of therapeutic areas. Dr. Artyomenko has spearheaded Medpace’s risk-based monitoring initiatives, bringing together the medical, regulatory, operational, and technology teams to deliver on the promises of RBM.