eCOA - Clinical Operations Connection
Features Brief

Streamline study start up and close out procedures with study and eCOA data alignment.

Overview

The productized connection between Veeva eCOA and Veeva Clinical Operations eliminates duplicate administrative data entry and automates document compliance during study builds and close-out.

Instead of manually configuring study, country, and site records during a study build, Veeva eCOA automatically receives this data from Veeva CTMS or eTMF. The connection also files eCOA documentation in Veeva eTMF, including eCOA specification documents and end-of-study media.

Document alignment is managed via standard artifact mapping, ensuring that as end-of-study media packages are generated, they are reliably ingested into the eTMF. This connected document flow ensures ongoing GxP compliance and eliminates the manual uploading and filing errors that slow study closeout.

How it Works

• Veeva Clinical Operations transfers study, country and site metadata directly to Veeva eCOA to automate system setup.
• The approved eCOA Design Specification is automatically transferred to Veeva eTMF and filed under the appropriate subtype and classification.
• When an eCOA user confirms a final study lock, eCOA data is compiled into PDF files by patient, transferred to Veeva eTMF, and automatically filed appropriately in the TMF taxonomy. Final subject casebooks can also be distributed directly to sites.

Business Benefits

• Expedites builds and improves quality

  Minimizes the risk of human error and data inconsistencies by transferring study, country, and site metadata automatically to Veeva eCOA.

• Improves consistency and alignment

  Establishes a single source of truth across the clinical platform to ensure alignment.

• Ensures reliable compliance with less effort

  Autofiles eCOA documentation natively into the eTMF to maintain GxP compliance without manual uploads, quality checks, or recordkeeping.

Read about the eCOA to Veeva EDC Connection.