Ask the Experts: EU-CTR – How to tackle the Requests for Information (RFIs) Challenge?
The EU CTR (Clinical Trials Regulation) no. 536/2014 became effective on 31 January 2022. Among all the challenges, Sponsors often…
How To Expedite Clinical Development Via Early Access Programs
If you are developing a drug for a rare disease in the European Union, you may qualify for an Early…
Ask the Experts: QPPV – What is it?
Before submitting your marketing application in Europe or the UK, thinking about the PharmacoVigilance System and its Qualified Person (QPPV)…
Key Points in the CTR Transition of Clinical Trials
Are you an innovator with a product undergoing clinical trial? This article covers all you need to know about the…
Patient Engagement Explained: Insights from a Patient, a Patient Association and a Pharmaceutical Company
Have you wondered about the role of patient engagement in healthcare product development? Currently, there is a huge emphasis on…
Ask the Experts: EU CTR/CTIS: Adoption and Early Experience
The EU Clinical Trials Regulation no. 536/2014 became effective on 31 January 2022 and the first approved trials are now…
Controversial and debated topics in Clinical Trials
A well thought out clinical strategy is critical for a clinical study, our experts of clinical study talk about the…
Interplay between ICH and Data Privacy – GDPR
As professionals in the life sciences industry, we work in a regulated environment and we are a key element in…