Clinical Trial Approval Solution

RIo

ABT Medical brings a comprehensive suite of Trial Master File (TMF) solutions to the clinical studies marketplace through its eTMF platform. This real-time solution contributes to audit readiness and makes clinical studies more efficient, more cost-effective, and less likely to be stalled by workflow delays.

WHAT OUR CLIENTS ENJOY

Streamlined Document Collection

  • Clinical trial master files (TMFs) can be uploaded from anywhere in the world.
  • All documents are collected in a centralized repository, with controlled document filing and access.
  • With a single-source portal, all documents are highly visible to users prior to final submission to eTMF.
  • Users can either send paper (with or without wet signature) or upload electronic documents into eTMF.

Audit Readiness at a Moment’s Notice

  • Full chain of custody across every step of the eTMF process: collection, transmission, and archival storage.
  • Full audit trail with critical information (e.g., when the document was submitted, when the document was viewed, user IDs, those authorized to submit documents).
  • At-a-glance status updates of all documents—both those in the system and those missing from the system.

Compliance

  • Secure (HTTPS), web-based Software as a Service (SaaS) solution, fully validated and 21 CFR Part 11 compliant.
  • Tailored access to restrict right-of-entry down to the document level, thus allowing users to only view documents to which they have been granted access.
  • Tier 3+ data centers that are SFA e-16 certified.

Business AffiliatesBusiness Affiations

Be Social