On each study, we focused on training for our CRAs, training them on the indication, site management, the drug, and the client’s preferred working practices. Our team ran regular retraining sessions and refreshers and shared information on procedures across the study teams. Our Quality Management Team visited high-enrolling sites who generated large volumes of data, meeting with investigators and their teams to highlight the importance of quality and discuss any areas where improvement was needed. Our project managers supported the sponsor team with mock audits and submission preparation, ensuring they were well prepared ahead of meeting with regulatory bodies.
We delivered LPI ahead of schedule on each of the studies to date
Our CRAs worked with each site individually, first getting to know the PI and site teams, then understanding barriers to recruitment before developing a mutually agreed plan with each site to enable them to enroll. We conducted site surveys, scheduled 1:1 discussions with the PIs and their site teams, and organized several recruitment enhancement meetings where the investigators shared their experience and brainstormed to propose potential solutions for the existing obstacles. These strategies enabled us to deliver LPI ahead of schedule on each of the studies to date, including completing one of the studies a year ahead of schedule and receiving FDA and EMA approvals in 2021.
PSI maintained a low turnover rate of just 15% for the key staff on this portfolio. Since we retained our staff, there was significant overlap across the portfolio teams, keeping valuable knowledge of the IMP and maintaining the site relationships to allow us to deliver recruitment that exceeded the global average. This was particularly critical during the two acquisitions this company went through, when new members joined and left the team on the client side. Our IBD therapeutic lead oversaw all the studies as Project Director, managing the knowledge exchange across the program and ensuring planning and execution of studies were aligned. Each process or SOP change from the sponsor also came through the Project Director, who ensured all teams were aligned, trained, and compliant.
Our IBD therapeutic lead oversaw all the studies as Project Director, managing the knowledge exchange across the program