As drug development moves through a period of significant innovation and complexity, our industry is faced with lengthened development timelines, increased costs and the need for greater global harmonization and planning across development functions. These changes have also brought increased regulatory challenges and cost pressures. Consequently, PPD’s study startup process has rapidly evolved over the past five years to address these challenges and increase global coordination and consistency.
PPD’s site intelligence and activation (SIA) group consolidates the vast majority of our startup activities into a global business unit. Our SIA group employs state-of-the-art technologies to help facilitate the startup process, drive industry-leading cycle times and offer additional flexibility in response to our clients’ outsourcing demands. This group includes service areas aligned in a uniquely holistic manner, including trial optimization/strategic feasibility, country/site selection, strategic site partnerships, investigator qualification, site activation (local regulatory submissions, site contracting and clinical startup) and patient recruitment.
Site identification and activation is an important component of clinical trials and has a critical impact on subsequent trial timelines, as well as site relationships. Our best-in-class approach employs sophisticated predictive analytics to refine the site selection process to identify high-quality sites with proven track records for meeting enrollment goals. This approach is expedient and efficient and ensures the highest quality and lowest risk. PPD’s approach to study startup activities is also differentiated by our data-driven methodology, our clear accountability mechanisms and the integrated nature of our model.
- Leverages PPD’s experience database and a variety of external data sources
- Utilizes scenario modeling, based on our data sources
- Single point of global accountability for clients
- Country team model for achieving aggressive, realistic forecasts
- Bundled local teams–regulatory, site contracts, clinical startup
- Strategic feasibility, trial design and site selection