A European leader in clinical pharmacology research and bioanalysis, Aster Cephac has more than 28 years of expertise in Phase I, IIa, proof of concept, and interaction studies
In order to provide its customers with the highest level of service and to guarantee long-term support, Aster Cephac announces the complete renovation of its central Paris clinical unit, which now offers cutting-edge technologies and improved compliance with international safety regulations.
A specialist in Phase I studies (more than 2500 clinical studies to date), the company has completed renovation work on its clinical unit, which has held ISO 9001 certification, ver 2000.
The unit now has a capacity of 80 beds, including 40 equipped for intensive monitoring.
Designed to optimise the clinical testing process and ensure data confidentiality, the new facility features centralised alarms, controlled access, and, most importantly, an impressive infrastructure that will enable the centre to perform cardiovascular tolerance studies (prolonged QT).
The Aster Cephac research centre has also provided its data management department with version 4.5 of Oracle Clinical, in order to comply with regulatory requirements (CFR 21 Part 11 and ICH6) and to ensure regular, efficient data transfer.
