About Us: Regulatory Compliance
Cmed Technology designed Timaeus from the beginning to enable research organisations to collect, manage and report clinical trial data in full compliance with global regulations and guidance.
Demonstration of compliance with existing global regulations and guidance
Small and large research customers and partners alike have extensively audited and accepted Timaeus’ demonstration of compliance with the following regulations and guidance:
- ICH Guidelines (E6 – GCP)
- EU Data Protection ACT
- FDA 21 CFR Part 11 – Electronic Record; Electronic Signatures
- FDA Guidance for Industry: 21 CFR Part 11 – Scope and Application
- FDA Guidance for Industry: Computer Systems Used in Clinical Trials
- FDA Guidance for Industry: General Principles of Software Validation
Forward engineering for conformance with emerging CDISC standards
In addition, Timaeus has been engineered to comply with the emerging CDISC standards. Its underlying data architecture naturally conforms to CDISC, improving ease of use and saving cost through elimination of unnecessary data mapping.
Timaeus can support correct patient identification using advanced biometric fingerprint technology. Fingerprints are never stored in Timaeus. Instead, Timaeus generates a unique number from the fingerprint, which can then be used to confirm the patient’s identity at the next study visit or assessment. This approach overcomes many of the problems caused by ensuring compliance with US HIPAA.
