How Do You Manage Risks in Clinical Trials?
Authorities have increased their interest in sponsor oversight and management of risks in clinical trials. Christoffer von Sehested, Director eClinical at Klifo A/S explains:
"Authorities have changed their focus from the general oversight to how you implement and maintain a risk based approach to monitoring.
Here, the key to success is an understanding of how you build strong mechanisms in a validated system, how you incorporate measurements for continuous improvement and how you maintain documentation."
Get inspiration on how you build a strong risk management system and maintain documentation at our course Risk Management From an ICH-GCP E6 (R2) Perspective on 8 May 2019.