Managing Regulatory Needs Abroad

Case Study

This was an international, double-blind, parallel-group, placebo-controlled, randomized study: evaluation of the efficacy and safety of the study drug in subjects (≥ 16 to 70 years old) with Partial Onset Seizures, in which PPD provided clinical, project management and pharmacovigilance services. The study included 400 patients, 89 sites, five countries and a 25-month timeline.

With increased regulatory document requirements and a preponderance of academic sites, startup delays were a major challenge. PPD leveraged its experience and relationships with sites to manage the regulatory needs abroad and maintain a successful outcome.