Danielle Giroud
With close to 40 years of experience, Ms. Danielle Giroud is an internationally recognized clinical research and regulatory expert within the global medical device industry. She has shared her extensive knowledge and experience with multi-national companies, organizations, and start-ups from around the world to help bring their products to market quickly and efficiently.
Ms. Giroud is also known for her contribution and engagement as founder and senior faculty board member of the World Medical Device Organization (WMDO). Since 2008 she is the convener for the expert group on clinical investigations (TC 194 WG4) for the ISO 14155 and clinical evaluation for the ISO 18969, and functions as a liaison with the EU Commission - Clinical Investigation and Evaluation, Performance Studies and Evaluation (CIEPSE) task force and other regulatory authorities throughout the world.
Topics
What Makes or Breaks a Clinical Investigation?
What are the key factors that determine the success or failure of a clinical investigation? This presentation explores the critical elements of clinical study planning and execution, from study design and endpoint selection to resource management and site selection. Discover common pitfalls, practical considerations, and key strategies to ensure successful clinical investigations.