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Eclevar x RegenLab: Innovation in Clinical Trials

Key Interview Highlights

Eclevar Client Testimonial

“The compliance for studies, you need a discipline, and the discipline is terrible, and this discipline, honestly speaking, you have it more reliable in France. That’s why we are a partner in your organization. I’m proud to do it.”

Antoine Turzi explains why RegenLab chose Eclevar as their CRO partner for pivotal studies.

Milo Technology Innovation

“With this Milo technology… you go beyond metadata because not only you have the ability to make synthetic arms, but you have the ability to make it vocal instead of paper and pen, which is amazing.”

Discover how the Milo platform revolutionizes clinical data capture through AI and voice technology.

Diabetic Foot Ulcer Clinical Trial Challenges

Antoine shares the specific challenges encountered when conducting clinical trials for the DFU (Diabetic Foot Ulcers) population and the innovative solutions developed by RegenLab and Eclevar.

Sufficient Clinical Data and Regulation

In-depth discussion on obtaining sufficient clinical data in DFU and aesthetic domains, and the importance of surveys in the European regulatory process.

Medical Devices and Reimbursement

Analysis of medical devices dedicated to diabetic foot ulcers, focusing on medico-economic data and reimbursement strategies in Europe.

MDR Challenges and PMCF Requirements

Exploration of challenges related to the Medical Device Regulation (MDR) and post-market clinical follow-up (PMCF) requirements for MedTech companies.

PRP Medico-Economic Aspects

Discussion on the medico-economic aspects of PRP (Platelet-Rich Plasma) and medical devices for diabetic foot ulcers in the current regulatory context.

From Pilot to Pivotal Study

Antoine explains how Eclevar supports RegenLab in the strategic transition from pilot studies to European pivotal studies, ensuring compliance and data quality.

Ready to Start Your Next Clinical Trial?

Discover how Eclevar can support your clinical trial projects with the same excellence as RegenLab.

Topics Covered

  • Compliance and discipline in clinical trials
  • AI innovation and Milo voice technology
  • MDR regulatory challenges
  • Clinical trials in diabetic foot ulcers
  • Medico-economic data
  • Post-market clinical follow-up (PMCF)
  • Pilot to pivotal transition
  • Study funding and valuation
  • PRP therapies and regenerative medicine
  • European reimbursement strategies

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