Data Driven Strategies for Improved Site Activation

Data-Driven Strategies for Improved Site Activation and Patient Enrollment Forecasting Introduction » As drug development costs have continued to increase, there is Experience indicates that the time for study start-up, from the first site increasing pressure to bring new pharmaceutical products to contact to site activation (Figure 1), depends on a few key factors: market faster and a need to find innovative ways to save time and money across the entire clinical trial lifecycle. Although enrollment challenges are often the focus of study timelines, there is substantial potential to accelerate the study start-up process, during site selection, • Type of site, such as academic sites or outpatient settings • Regulatory review process by a central or local EC/IRB • Ability to conduct approval and negotiation processes in parallel ethics committee and institutional review board (EC/IRB) approvals, • Previous and current working relationship with the sites, including contracting, budget approval, site initiation, and enrollment. the availability of performance data Improvements in any of these tasks can reduce the total clinical trial cycle time.1 Moreover, a recent study indicated that reduced delays during study initiation could be achieved by data-driven site selection, sponsor visibility into the process, electronic documents and workflows, and an integrated process between the contract research organization (CRO) and the sponsor.1 Clinipace Worldwide has sought to streamline the study start-up process through improved processes based on a combination of experience, analytics, and technology. This approach to study start-up has identified opportunities to save time and provide a highly accurate and sophisticated model to forecast study timelines, enabled by TEMPO™, a proprietary, cloud-based e-clinical software platform. Figure 1. Study start-up involves a number of processes. The In this way, the study start-up process is truly data-driven, showcasing characteristics of specific steps influence the time to activate a site the promise of the digital contract research organization (dCRO) model. and are incorporated in the forecasting of the study start-up timeline. It typically takes ~100-200 days for study start-up, while forecasting provides a more accurate expectation for each specific study. clinipace.com 1

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