Timaeus-as-a-Service: Full-Service Study Closeout
Timaeus-as-a-Service (TaaS) is a full service delivery model designed to make eClinical operation as easy as using a utility such as electricity. Cmed manages all aspects of technology, enabling you to treat Timaeus as a utility that will always be ready and available. Instead of worrying about technology, you can to focus on your clinical programs.
Full-Service Closeout, Archive and Escrow
After a study is locked, all Timaeus user accounts will change to read-only database access, so that users maintain access to their study data. A site archive DVD will be produced and provided to each site containing blank CRFs, final CRF versions and full audit report. Cmed Technology will also provide a copy of all site archives and a study archive (aka sponsor archive). At this point access will be revoked for all users as per regulatory requirements by our Global Help Desk team.
Included Services
- 21 CFR Part 11-aligned removal of access for all required users
- Trial Archive DVD
- Site Archive DVD (copies of each site for you and for each Prinicipal Investigator)
- Full audit trail of each data change throughout the trial
- Final CRF versions
- Blank CRFs (including annotations)
Your archive matriasl will enable Cmed to re-create the entire state of the trial at DBL, any time in the future, if required.
