What Makes or Breaks a Clinical Investigation?

We are delighted to welcome back Danielle Giroud to speak at Labquality Days in the Clinical Evidence Generation session!

Labquality Days is one of Northern Europe's largest annual international congresses focusing on quality in laboratory medicine and health technology, and next year marks the 50th anniversary of the congress.

With over 35 years of experience in the medical device and in vitro diagnostic industry, Ms Danielle Giroud is the founder of MD-Clinicals, a CRO focused solely on medical devices and in vitro diagnostics.

Ms Giroud is regarded as an internationally recognised clinical research and regulatory expert. She has shared her extensive knowledge and experience with hundreds of multinational companies, organisations, and start-ups worldwide to help them bring their products to market quickly and efficiently.

She is also known for her contribution and engagement as founder and senior faculty board member of the World Medical Device Organization and is a recognised subject matter expert providing extensive training around the world.

Since 1998, she has been extensively involved in ISO work and became in 2008 the convener for the expert group on clinical investigations (TC 194 WG4) for the ISO 14155 and 18969 on clinical evaluation. From her position as a convenor of the TC 194 WG 4 she is a firm believer in regulatory convergence and established the liaison with the EU Commission - Clinical Investigation and Evaluation (CIE) task force and other regulatory authorities throughout the world.

Ms Giroud's lecture at Labquality Days, titled "What Makes or Breaks a Clinical Investigation?" will cover, step by step, the development of a clinical study design for medical devices, providing numerous examples and practical tips to make a clinical investigation a return on investment.

In addition to her lecture, Ms Giroud will host a Satellite Workshop on Clinical Investigation Design. This is a great opportunity to gain a deep understanding of critical design elements and methodologies for medical device clinical investigations, with an emphasis on achieving regulatory compliance. The number of participants will be limited, so reserve your place when you register for the congress!