Sponsor Achieves Inspection Ready State In Less Than 8 Weeks Across 70+ Studies

TOP 10 PHARMACEUTICAL SPONSOR PARTNERS WITH TRIFECTA & VEEVA FOR A MORE COMPLETE, INSPECTION READY STATE IN < 8 WEEKS

Executive Summary

 

Customer Top 10 Pharmaceutical Sponsor
Scope Automated transfer of all investigator training records, certificates of attendance and supporting documentation from Trifecta InvestigatorSpace® to Veeva Vault locations.
Timing Aggressive — Less than 8 weeks to deliver fully customized integration
Key Stakeholders Information Technology, TMF and Records Management, Quality, Global Clinical Operations, Global Training Management, Veeva, Trifecta
Results On-Demand, Live Training records automatically transferred + inspection ready 180,000 records across 70+ studies; ~6000 hours saved (2.8 work years) 29 days ahead of schedule.

OVERVIEW

 

A major Top 10 Pharmaceutical Sponsor engaged Trifecta and Veeva to collaborate and support innovation to reduce complexity in managing investigator training records and accelerate the document management process from Trifecta’s InvestigatorSpace® to Veeva Vault. Specific documents to be transferred included: on-demand training and live meeting records. On-demand records included: training certificates, training modules, and exemption support documentation. Live meeting records included: certificates of attendance and meeting agendas. Project requirements included instant and automatic eTMF archival and customized file structures meeting CDISC standards and associated Metadata during document transfer. During the Discovery phase, Sponsor shared goal to align the integration with the release timing of Veeva.

CHALLENGE

  • Maintain a state of inspection readiness to reflect current, error free records for on-demand and live meeting training + migrate all legacy records
  • Deliver efficiency and improved workflow by fully automating the electronic transfer of all Trifecta InvestigatorSpace® training and documentation to the appropriate location inside the Veeva Vault clinical operations platform including training certificates, modules, exemptions and all supporting documentation. Importantly, this transfer must include supporting physical documentation for all training exemptions, including reference for how training was received (online, live meeting, etc.)
  • Identify training record errors well ahead of regulatory inspections
  • Design integration to support live investigator meeting certificates of attendance
  • Deliver on accelerated timing to align with Veeva

RESULTS

 

RECORDS TRANSFERRED

180,000 records at time of integration across more than 70 studies

 

DELIVERY

Integration was implemented ahead of schedule (29 days in advance) from initial project establishment to fully integrated, including migration of legacy data The integration of Veeva and Trifecta provided many benefits that progressed the eTMF to a more complete and inspection ready state, including these significant gains:

 

Less Compliance Risk: Training documents are now automatically uploaded, named and filed in the appropriate classifications in the eTMF for any specific trial. Mapping activities driven by the integration effort facilitated data cleansing and identified errors well ahead of an audit or inspection.

 

More Efficiency Using a Single System for Quality Checks: The integration gives Sponsor the ability to drive efficiency with trial execution by eliminating the need to access multiple systems for quality audits. This not only simplifies, but allows focus on core trial activities including:

  • Facilitating more efficient regulatory inspections and approvals
  • Facilitating the exchange of records and information between departments
  • Simplification of periodic reviews & archival processes

 

More Time and Resource Savings: The integration represents a significant savings in time and resources required to maintain a state of inspection readiness. Reducing the number of manual uploads of training documents drives these savings. For this integration, it is estimated that each document requires approximately two minutes to upload. Applying this upload estimate across the 180,000 records integrated, time savings delivered is ~6,000 hours, or 2.8 work years.