Since the development of the ICH GCP guidelines, clinical trials are more and more complex in a stringent regulatory framework. The process of conducting a clinical trial is a costly step and the number of wasted dollars is staggering. Setting up and conducting a clinical trial is not easy and sponsors can fall into the trap of the facility and waste a lot of time and money before putting their product on the market. Every clinical trial is actually a project and with any project, there are hurdles to overcome and best practices to put in place.
Key learning objectives:
- Understand the pitfalls that can be easily avoided
- How to put in place tools and best practices to ensure a smooth conduct of a clinical trial
- Key take-home message to keep in mind when conducting a clinical trial
Emmanuel Prades, Senior Director, Clinical & Vigilance Operations
With 20 years in diverse areas of the pharmaceutical industry, Emmanuel Prades has considerable expertise in project management for the clinical operations processes. He has worked on submission files management. investigator meeting, initiation, steering or adjudication board management.
Adeline Darchy, Clinical Project Manager
Adeline has gained more than 10 years of experience in clinical research from both the CRO and sponsors sides. As a project manager, she was in charge of managing the clinical project while taking into account the research limitations, GCP and local regulations. She has focussed expertise in working with projects from phase II to phase IV, in oncology endocrinology, neurology, aesthetic and pediatric fields.