Q1 2016 saw the User Acceptance Testing of the new EU portal/Clinical Trial Application system begin.
BioKinetic Europe, Niche Science & Technology and Richmond Pharmacology, all of whom have a network of active members in AHPPI are registered testers on behalf of AHPPI and EUFEMED. The new portal is hoped to harmonise the reporting and approval system for the regulatory process for clinical trials across Europe. More information on the Clinical Trial Regulation and EU Portal and Database can be found here.
Release 0.1 covered the functionality to prepare and submit an initial clinical trial application as well as the process of the Member State appointing the reporting Member State. Feedback was consolidated by SGS Belgium.
We look forward to continuing the feedback process and providing input into such an important development for clinical trials as a whole in Europe.
Written by Aaron Clements, Associate Project Manager at BioKinetic Europe.