webinar
How to Secure Early Stage Development and First-In-Human Studies
We co-organized this digital event with Biopôle Lausanne. On this Webinar: Biopôle presentation (Olivier Philippe) …
publication
General Data Protection Regulation and Patients Enrolled in EU Clinical Trials
Processing and cross-border flows of personal data significantly increased over the past decades in the EU, and it became necessary…
publication
Clinical Trials with GMOs in the EU – From Regulatory to Sites
Clinical trials (CTs) with investigational medicinal products (IMPs) that contain or consist of genetically modified organism(s) (GMO-IMPs) have significantly increased…
publication
Verifying and Validating Quantitative Systems Pharmacology and In Silico Models in Drug Development: Current Needs,…
The added value of in silico models (including quantitative systems pharmacology models) for drug development is now unanimously recognized. It…
publication
A Regulatory Landscape Shift for In Silico Clinical Trials
Modelling and simulation (M&S) has grown to become a reliable approach to better understand and optimize key decisions related to…
webinar
Pitfalls and Best Practices When Conducting a Clinical Study
Since the development of the ICH GCP guidelines, clinical trials are more and more complex in a stringent regulatory framework.…
webinar
Initiating Clinical Trials in the EU: Current Scenario and Upcoming Changes
With 28 member states and associated countries, initiating a clinical trial in the EU is perceived by many in the…
whitepaper
Are Registries the New “Gold Standard” ?
There are multiple definitions associated with a registry and any future sponsors can feel anxious when it is time to…
