December 2018
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.