Genius eDOCUMENTUM is a cloud service and validate solution that enables the secure, long-term retention of clinical trial documents, accessible online for instant viewing and sharing among the different authorized stakeholders and for auditors or regulators in case of inspections or requests.
Features
- Available as a cloud subscription service, offering read-only access to the trial documents to authorized personnel.
- Provides a robust, scalable, fault-tolerant, cloud-ready, and extensible architecture to store and control all study documents
- Direct connection with Veeva Vault eTMF
- Possible integration with different eTMF applications
- Controlled repository access and improved compliance through fine-grained authentication, authorization, and audit trail
- No risk of media deterioration and/or obsolescence
- Fast set-up (10 days)
- Access granted both on a continuous basis (24/7) or on demand, when needed
- Fully compliant with articles 57 and 58 of the new European Regulation on clinical trials and with GCPs
- Offered in two versions for the long-term archive of both the eTMF and eISF documents