Episode 12 - Managing Successful Clinical Studies

On this episode of the BOEI Podcast, we’re chatting with three members of the Medevise clinical team about their backgrounds and how they successfully manage clinical studies for our clients.

Speakers:

• Kristine Morrill, Founder and President of Medevise Consulting

• Claire Holtzinger, Clinical Project Manager

• Xavier Martin Benlloch, Clinical Project Manager

• Anne-Sophie Wilding, Clinical Scientist

Key Takeaways:

• Claire Holtzinger is trained as a material scientist, with an engineering degree, a PhD, and a Master’s Degree in Innovation Management. She has worked in research, at the Institute of Image-Guided Surgery, and in IP management.

• Xavier Martin Benlloch is a medicinal chemist by training, with a PhD and a Master’s Degree in Innovation Management. He has worked in drug delivery, image-guided research, and at a healthcare start-up incubator.

• Anne-Sophie Wilding is trained as a cognitive scientist/biologist with a PhD in neuroscience, and a Master’s Degree in Innovation Management. She has worked in preclinical research, and regulatory and clinical management for medical device software.

• All three attended the same Master of Innovation Management program at the University of Strasbourg.

• They discuss how Medevise takes a medical device through the MDR to a CE mark, and our clinical team’s strategies for achieving faster approvals from ethics committees and competent authorities.

• Requirements for clinical approvals vary between countries. Our team often receives feedback from competitive authorities from different countries or regions with their preferences for specific text. We document these specifics and integrate them into newer submissions automatically, making the approvals process faster with each subsequent submission.

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