De-risk Clinical Trials by Starting with Patient Insights and their Integration
Have you ever asked yourself how, as a patient, you would react if your physician proposed you to participate in…
Sponsors of Clinical Trials in the EU/EEA – Call for Action!
2024 is here and will be a crucial year for your clinical trials in the European Union (EU) and European…
Best ePRO practices – A patient centric approach
The adoption of Electronic Patient-Reported Outcomes (ePRO) in clinical research marks a significant evolution in the way patient-centered data is…
Getting an Early Access Program Off the Ground Safely
Embracing an Early Access Program (EAP) presents a strategic avenue for creating valuable opportunities for patients and companies. This webinar…
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…