A global leader in vaccine development and innovation chose George Clinical to perform project management, site management and monitoring, centralized monitoring, data management, vendor management (EDC build), medical monitoring, and safety management for a Phase III trial of a primary dose intra-nasal COVID-19 vaccine to be conducted for safety and immunogenicity in over 3,000 subjects in multiple sites across India.
George Clinical came on board as a full-service provider for this study less than two months prior to the planned first volunteer enrollment date, making for very compressed timelines across all disciplines. Site selection had already taken place as well as ethics and application. Almost immediately after the contract was awarded, Ethics Committee approvals started coming in, which set all operations into motion. Given the pace that things were happening, it was imperative to ensure that optimal operations were in place and recruitment for more than 3,000 volunteers could begin immediately. Even as study documents were being revised, the timelines remained the same.
Some logistical issues needed to be addressed, as well as the coordination of many interdependent, cross-functional teams. Since large amounts of data would be coming in quickly, the database had to be set up at break-neck speed. Some changes to the sponsor’s study documents had to be made in order to meet regulatory requirements.
Given the high number of subjects and volume of data, it was a challenging task for sites since they had to enroll subjects, ensure all follow-up visits were made, complete source documentation as per quality standards, and enter the data in eCRF in a timely manner. The monitoring strategy had to ensure the safety of the volunteers and the integrity of the study despite the fast recruitment and possibilities of source data verification backlog. Medical monitoring was extremely critical due to the novel delivery system and the importance of the study outcome to the future of global vaccines.