Managing Multiple Sites Across Many Countries

Case Study

In this Phase III program investigating the safety and efficacy of a novel anti-psychotic for treatment of acute exacerbation of schizophrenia, PPD conducted a Phase III program involving 17 countries; 13 languages; 34 monitors; 172 investigative sites; 2,200 patients; and 1,420,000 CRF pages.  PPD provided clinical, medical monitoring, pharmacovigilance, data management, biostatistical and regulatory services to help complete all necessary information for a final NDA submission.

The major challenge for this study was managing multiple sites across many different countries as well as the movement of data and reports related to the study.  PPD mobilized its global resources and technologies to stay ahead of schedule and under budget to help the client proceed without delay to one of its most successful product launches ever.

PPD’s automated telecommunications systems, advanced information services and clinical expertise expedited study startup and data reporting to ease the burden for the client.