Case Study – Major Japanese Pharmaceutical Sponsor Achieves Over 96% Safety Acknowledgment Compliance for 2 Consecutive Years

Executive Summary

 

Customer Top 10 Japanese Pharmaceutical Sponsor
Scope Validate a system solution that allows unified management of adverse events (SUSARS & SAE) across the enterprise to improve quality of documentation and CRA efficiency while accelerating site communications in accord with regional and country regulatory standards
Timing Sponsor engaged in a trial study to measure organizational results and ROI starting in late 2018
Key Stakeholders Clinical Operations, Clinical Research Associates (CRAs), Study Teams, Principal Investigators (PI)
Results Increased Efficiency: CRAs reported that SafetyVigilance reduced working hours via the ability for system to eliminate redundant and non-value added processes. SafetyVigilance® also optimized processes to give PIs more control over critical documentation.

 

Improved Quality of Documentation: Implementation of SafetyVigilance significantly improved quality of adverse event documentation with improved processes and tracking methods. This allowed both the study teams and CRAs to track all records and gain enterprise—wide visibility to records for a more unified management of adverse events.

 

Significant Costs Savings Via Reduced Administrative Burden & Labor: Return on Investment was measured by achieved reduction of labor and improved efficiency of CRAs and study team members.

Overview

 

A Japan-based pharmaceutical sponsor partnered with Trifecta to assess the impact of Trifecta’s online safety event delivery solution (SafetyVigilance®) within sponsor’s enterprise safety event processes. Across studies, CRAs reported complexities with current adverse event documentation processes including: difficulty tracking records, resulting errors in documentation with CRA turnover, misplacement and/or misfiling of emails containing adverse event documentation. Sponsor evaluated several solutions, but only Trifecta’s SafetyVigilance® was equipped to meet all sponsor requirements. Sponsor then engaged in a single trial study where CRAs used and experienced SafetyVigilance to record adverse events for that study. At the end of a specified time period, CRAs recorded overall experience and time savings via questionnaire for analysis. After analysis was complete, sponsor traveled to Trifecta’s Los Angeles, California headquarters to meet with Trifecta’s Quality and Operations teams to review all documentation, procedures, processes, testing and production support.

Challenge

 

  • Improve CRA efficiency by automating processes and time consuming non-value added activities for documentation of adverse events
  • Ensure quality and reduce likelihood of errors associated with CRA turnover and misfiling of emails
  • Meet and exceed sponsor requirements and complexities of working within regional regulations
Intuitive, Easy-to-use User Interface
Trifecta’s SafetyVigilance has a very intuitive, easy-to-use user
interface. While simple, it met all our requirements including sending letters, reminder emails, and integration with training modules.
- Sponsor validation manager

Results

 

INCREASED EFFICIENCY CRA’S REPORT SAFETYVIGILANCE® REDUCED WORKING HOURS

CRAs reported that SafetyVigilance® reduced working hours via the ability for system to eliminate redundant and non-value added processes. SafetyVigilance® also reduced difficulty of tracking records when sponsor experienced CRA turnover, ensuring accurate and automatic recording of documentation to support all adverse events with visibility to documentation across the entire enterprise.

SAFETY EVENT PROCESSES OPTIMIZED GIVING PRINCIPAL INVESTIGATORS MORE CONTROL

After Principal Investigators were introduced to the systems and trained in the new process, most activities were automated so PIs could complete within the system; eliminating a major piece of the work once done by CRAs. Importantly, use of the system allowed PIs more control over the process which helped improve accuracy and timeliness of documentation.

 

IMPROVED QUALITY OF DOCUMENTATION VISIBLE ACROSS ENTERPRISE

Implementation of SafetyVigiliance significantly improved quality of adverse event documentation with improved processes, tracking methods and automatic recording within this system. This allowed both the study teams and CRAs to track all records and gain visibility to documentation for a more unified management of adverse events.