The TCC has extensive experience in constructing and managing clinical study databases. We are also careful to work within all applicable regulatory requirements. Key aspects of our service are:
- developing an appropriate structure for the database based on the case report forms.
- ensuring that the database is accessible for authorized investigators and study staff.
- harmonising the statistical analysis and clinical reporting processes.
- providing a guaranteed daily back-up to a different physical location.
- securing the database using password protection and secure Internet connections.
- registering revisions (audit trail).
- and safeguarding study continuity if study staff leave or new staff are appointed.
The TCC uses the most recent validated version of the Oracle Clinical database software available. This package has been specially developed for clinical research and is widely used in pharmaceutical and clinical research. It also allows investigators to retrieve data directly from the database.