26 days to evaluate your clinical trial thanks to AEMPS’ fast-track assessment
The Spanish Agency for Medicines and Health Products (AEMPS) has implemented a new accelerated assessment procedure for certain clinical trials. This initiative aims to make Spain a more attractive environment for innovative drug research. Below, we explain which trials can take advantage of this fast-track process that reduces the evaluation time from 45 to 26 days
EMA certifies Sermes CRO as a key entity in the CTIS Training plan
Sermes CRO has been elected by the EMA as “Train of trainers” for the new Clinical Trial portal, CTIS (Information System).
Sermes CRO: Updated info about The EMA´s new EU portal of clinical trials (CTIs)
The European Medicines Agency (EMA) aims to have its Clinical Trial Information System (CTIS) ready by December 2021, committing itself to this objective in updating its plans for 2021.
The EMA & The FDA co-presede the first regulatory workshop on Covid-19 for vaccine development
Yesterday 18th of March, 2020, the first global regulatory workshop on COVID-19, was convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA).
AEMPS publishes recommendations during the crisis period by COVID-19 in Spain
Exceptional measures applicable to clinical trials to manage problems arising from the COVID-19 emergency
Sermes CRO: AEMPS approves the NC1 advance therapy drug for patients with chronic traumatic medullary injury
The NC1 cell therapy drug for patients with chronic traumatic spinal cord injury has been authorized by the AEMPS for public use at hospital use. NC1 has been developed by Dr. Vaquero and Dr. Zurita at Puerta de Hierro University Hospital with the collaboration in the clinical research of Sermes CRO and the Sermes Foundation.