GENIUS eTMF™ > ELECTRONIC TRIAL MASTER FILE (eTMF/eISF)
While large strides have been made in clinical data collection with EDC solutions, the processes of collecting and organizing clinical documentation such as CVs, ethics committee approvals, case report forms, informed consents and many more is still largely manual, paper-based and stand-alone.
Genius eTMF™, by Veeva, is our digital and validated solution for the clinical trial filing issue, because it provides a single, secure Type II certified internet data center for all clinical players for sharing any study document, in a standardized and fully reportable system.
Genius eTMF™, brings all study stakeholders, CRO, Sponsors, and Investigator sites together in the regulated cloud. Sponsors get complete document visibility with real-time dashboards and actionable reports.
Benefits of Genius eTMF™
- Appropriate filing and easy retrieval of the documents by a search option that means Correct coding (= name) and classification of the documents
- Document filing on an ongoing basis
- Quality Control on an ongoing basis
- Remote access to study documents from any place and at any time
- Effective security features to avoid unnecessary deletion or change of documents from the site
- Real time metrics on filed documents
- Availability of documents globally, addressing issues with access for all concerned parties
- Reduces duplication, so only one version needs to exist
- Reduces fragmentation of the TMF
- Ability to provide access to the same type of document across all studies/sponsors/product
- Search features
- Environmental benefits (reduces need for paper, document transit and travel for audit/inspection/trial management etc.)