A customised central database is prepared for each study and is the foundation for all aspects of our service for either “traditional” laboratory services or central services using local laboratories.

Each database contains all pertinent study specific related information and functional processes. A full database validation exercise is performed and a formal report provided to the client for approval prior to the start of any study. This Validation Report meets regulatory requirements and defines our understanding of the study protocol, the services being provided and is included in the Study Master File.

Both external and internal security measures are taken to ensure database integrity at all times.

All processes are 21CFR part 11 compliant, are monitored internally and can be reviewed using the electronic audit trail function.

Components of the Central database include the following: