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 start-up 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 start-up activities into a global business unit. Our SIA group employs state-of-the-art technologies to facilitate the start-up 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 and strategic feasibility, country and site selection, strategic site partnerships, investigator qualification, site activation (local regulatory submissions, site contracting and clinical start up) and patient recruitment.
Site identification and activation has a critical impact on subsequent clinical trial timelines, as well as site relationships. Our 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, ensuring the highest quality and lowest risk.
• 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 start up
• Strategic feasibility, trial design and site selection