Executive Summary
A European pharmaceutical sponsor initiated a multi-country phase 3 confirmatory trial to evaluate the efficacy and safety of a once-daily gastrointestinal drug. Its primary contract research organization (CRO) for Southeast Asia and Eastern Europe selected PiVOT to manage operations in the Philippines because of its regulatory expertise, strong site relationships, and a record of delivering audit-ready results.
When enrollment lagged in other countries, the sponsor reallocated patients to the Philippines. With PiVOT overseeing local operations, trial sites delivered:
- A 64.6% increase over target enrollment (113 planned, 186 enrolled) in 2 months
- On-schedule execution across all sites
- Full protocol compliance and audit-ready standards
- High-quality data that supported the regional database lock
- Completion of the original target ahead of other participating countries by 1 month
Trial at a Glance
A European pharmaceutical company sponsored a phase 3 randomized trial to evaluate the efficacy and safety of a once-daily dyspepsia drug. The goal was to confirm therapeutic effectiveness and improve adherence through simplified dosing.
A primary CRO managed operations across five countries in Southeast Asia and Eastern Europe: Armenia, Vietnam, Malaysia, Thailand, and the Philippines.
PiVOT, a Filipino CRO, was selected to lead clinical research operations in the Philippines, including site selection, regulatory submissions, and monitoring.
Study Design:
- Trial Phase: Phase III
- Trial Design: Randomized, multicenter, parallel-group, open-label, active-controlled study
- Therapeutic Focus: Functional dyspepsia
- Treatment Duration: 2 months
- Patient Profile: Adults with confirmed dyspepsia; ~60% women
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