Resources
Clinical trials & start-ups: Why CROs are essential
Clinical trials & start-ups: entering the clinical trial phase is a decisive milestone for any innovative health company. For a start-up developing a drug, a
Medical Device Vigilance in Clinical Trials: Obligations and Common Mistakes to Avoid
Medical device vigilance in clinical trials is one of the most demanding regulatory requirements introduced by Regulation (EU) 2017/745 (MDR). Since the Regulation became fully
EU Legal Representative for Clinical Trials: Why It Is Essential
Appointing an EU Legal Representative for your clinical trials is now a legal requirement for any sponsor established outside the European Union wishing to conduct
GDPR Applied to Clinical Trials: 2026 Compliance Checklist
GDPR applied to clinical trials: in 2026, compliance in health research can no longer be treated as a mere administrative addendum. It is an integral
Developing an innovative medical device: Key steps from design to CE marking
Developing an innovative medical device requires much more than a strong idea or an impressive technological breakthrough. Accessing the healthcare market demands rigor, method and
Economic Simplification Act: What Impact on Clinical Research in France?
The Economic Simplification Act, published in the French Official Journal on May 27, 2026, aims to reduce administrative burdens affecting businesses, public institutions, and innovation
