News

For the first time, sponsors can test a coordinated assessment involving a clinical trial of an investigational medicinal product (IMP) together with a performance study of an in vitro diagnostic (IVD) and at a later stage an investigation of a medical device via the European COMBINE Projects
What’s the goal?
 ✅ Reduce administrative burden
 ✅ Speed up patient access to innovative combined treatments
 ✅ Harmonise requirements under CTR, MDR and IVDR
Although the pilot phase has just begun, one thing is clear: Combined studies can be a regulatory maze — but they don’t have to be.
We know the ins and outs of drug trials under the CTR and medical device studies — so we’re ready to help our clients explore this new pilot project and make the most of it.
 Let’s make combined studies less complicated — and more impactful!
Planning a combined study? Let’s talk!