Data Driven Strategies for Improved Site Activation

full visibility to all of the information stored in TEMPO. Additionally, the data are utilized in the forecasting model for activation and enrollment. Does it work? » With a recent clinical trial, Clinipace Worldwide used the dCRO model and start-up strategies discussed in this paper, such as conducting site initiation visits prior to EC/IRB approval, execution of the contract, and approval of essential documents. In previous trials, the average time to open a site was 6 months. In this recent trial: • One academic site opened in approximately 1 month • One non-academic site opened in approximately 3 months • Two academic sites opened in approximately 3 months • To select 20 sites for the trial, 45 sites were approached For each step in the process, the following average times were reached: • 34 days between the regulatory packet delivered to the site and submission to the EC/IRB • 26 days for EC/IRB approval, from the date of submission • 64 days for the contract to executed, from the date the regulatory packet was delivered to the site Figure 6. TEMPO was developed as one database that seamlessly These times reflect ongoing advancements in the dCRO process within integrates all of the trial lifecycle components, shifting the focus from Clinipace Worldwide, with the utilization of additional and evolving administrative tasks to the benefits of the team’s experience and technology. Of note, the time for EC/IRB approval is highly dependent on improved processes. the type of site (central vs local IRB, Figure 6). While the dCRO process The recognized benefits of a clinical trial management system, such as TEMPO, include a better understanding of resources, improved internal and external communication across all sites, reduced human error in data entry and reporting, improved knowledge flow across all operational departments, current and future management of clinical data, and continuous monitoring and improvement of study processes and performance.3 Clinipace Worldwide and all other stakeholders have expedites the time to submission, the time to approval is based on the EC/IRB processes and cannot be modified. The team observed that the dCRO model provided full visibility, with reports and metrics, to allow the focus to remain on the sites that remained interested during the start-up process. Resources could be appropriately applied to those sites and removed from the sites that did not respond to the initial requests. With further dCRO model experience, clinipace.com 8

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