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Pitfalls and Best Practices When Conducting a Clinical Study

Post thumbnail Pitfalls and Best Practices When Conducting a Clinical Study

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

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    Featured Speakers

    Emmanuel Prades, M.Sc. thumbnail
    Emmanuel Prades, M.Sc.
    Senior Director, Medical Devices
    With over 20 years in Clinical development in diverse areas from pharmaceutical to medical device industry, Emmanuel has broad technical expertise in clinical trial regulations and associated country-specific requirements and has extensive experience in various trial phases, product types, indications, and geographical areas. He has extensive experience in strategic clinical decision meetings with various cross-functional activities for regulatory, safety, quality, and study organization. He also has experience in quality as a clinical QA advisor (audit, SOP writing, Team training).
    Adeline Darchy thumbnail
    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.