The regulation on clinical trials (CTR) on medicinal products (EU No 536/2014) was adopted on 16 April 2014 and will finally enter into force on 31 January 2022, once the Clinical Trials Information System (CTIS) portal, maintained by the European Medicines Agency, goes live.
The CTR and the CTIS portal provide one submission channel for clinical trials on medicinal products in Europe. The ultimate target is to harmonise the assessment, management and supervision of clinical trials on medicinal products throughout the European Union. It is therefore essential to prepare for the new system by getting to know its processes and functionalities in order to get the full benefit of it.
Medfiles has been preparing for the CTR already for years by adapting and updating our Standard Operating Procedures (SOPs) to meet the new requirements. Lately we have intensively trained and educated our clinical trial, quality assurance and safety teams CTIS system.
Medfiles offers comprehensive services for Phase I–IV clinical trials on medicinal products. We provide flexible solutions from individual services to complete study packages, with services ranging from study planning to final reporting. Our service portfolio covers protocol preparation, submissions, project management, monitoring, safety management, data management and statistical analysis. In addition to clinical trials on medicinal products, we also support medical device investigations as well as food and nutrition studies, which is one of our special expertise areas.
For more information please contact us!