Regulatory Compliance

As a 21st century “fit for purpose” system, Timaeus is breaking new ground and setting new standards.

It has been carefully designed from the beginning to meet and exceed regulatory standards. Along with Cmed’s SOPs and processes, Timaeus has been extensively audited and accepted by many clients to be fully compliant with ICH GCP, FDA: Computerised Systems Used in Clinical Trials, and FDA: 21 CFR part 11.

The system has been engineered to comply with the emerging CDISC standards. Its underlying architecture naturally conforms to CDISC, meaning ease of use and substantial cost savings from unnecessary data mapping.

Timaeus uses Extended Mark-up Language (XML) as central to its eCRF screen / data structure design and database assembly. We have built and used an Operational Data Model (ODM) to import data into Timaeus from another data management system, for a very large study when mounting a rescue of a study from a CRO, on behalf of a large pharmaceutical company. And so we are able to provide clients with Timaeus data in CDISC SDS-compliant data sets.

Uniquely, Timaeus can support correct patient identification using advanced biometric fingerprint technology. Fingerprints are never stored in Timaeus: instead a unique number is generated from the fingerprint, which can then be used to confirm the patient’s identity at the next study visit or assessment. This approach, which is optional, overcomes many of the problems caused by ensuring compliance with HIPPA.