Site activations are a main component of PPD’s site intelligence and activation (SIA) group. This area includes study startup activities and local country regulatory submissions by region, global site contracts, and budgets and CTMS setup activities. The SIA group functions under a single, global leader, SIA study team manager (STM), who brings significant experience related to site activation strategy and delivery. The SIA STM will ensure heavy use of data analytics and clinical experts to inform the process for protocol development, trial planning and optimization, strategic selection of sites and activations.
The SIA STM is also accountable for the customer-focused leadership and management of site activation deliverables on a global trial. The technical and operational aspects are also directed by the SIA STM, including site activation deliverables, such as coordination of feasibility, site contracts, regional STMs and country teams per the project scope to timelines, costs and quality. Through this direction, PPD ensures collaboration among major functional area leads, SIA country managers, project management, clinical management, clinical administration, clinical supplies and regulatory affairs to identify and evaluate opportunities and risks to the deliverables, and ensures effective action plans are implemented. The SIA STM establishes the initial project activation timelines and works to ensure individual project targets are met, clients are satisfied, services are provided with the highest quality standards and policies and procedures are followed. The site activation process is critical to maximizing each site’s enrollment period.
PPD’s approach to study startup activities is differentiated by our data-driven methodology, our clear accountability mechanisms and the integrated nature of our model. Additionally, our SIA team 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.