Essential Keys to Clinical Trial Success with Clinical Monitoring Oversight

Registration is open

Executing a clinical trial is a highly complex undertaking, with multiple moving parts. Whether insourced or outsourced, maintaining a level of quality assurance of the monitoring study during the conduct of a trial is essential and requires a strategy that enables everything to be executed the ‘right way’ to ensure critical deliverables will be delivered on time and on budget.

Join us on this 60-minute webinar as our experts provide insights into the main challenges and complexities of clinical trials and why having Clinical Monitoring Oversight (CMO) is important to studies success.

Learning Objectives:

• Overviewing and assessing the vendor for oversight monitoring: Strategic considerations, internal capacity drivers, available skill sets and cost
• Ensuring successful partnerships when outsourcing CMO : Providing insight into site and CRA performance, ensuring protocol procedures in agreement with ICH E6
• Monitoring the collaboration: Defining the operational team, the risk management process, key milestones, and involving senior management for issue escalation and resolution
• Discussing effective mechanisms for problem resolution: Mitigating problems quickly and avoiding costly delays by involving senior management in issue escalation and resolution

Speakers:

• Donna A. Cullen, CLSSS, RQAP-GCP, Sr. Director, Clinical Excellence at Intercept Pharmaceuticals
• Cornelis Winnips MD, Global Program Clinical Head at Novartis
• Brian Nugent, Sr. Director, Clinical Compliance at Travere Therapeutics
• Adam Kulik, MD (Moderator), Associate Director, Global Clinical Operations at KPS Life