Changes in resources for both the client and PRA teams led to significant challenges with the start-up and enrollment activities in Europe and North America. Because the study’s enrollment criteria and endpoint involved invasive procedures, project team members questioned whether sites would be interested, and if the subjects could be enrolled in a reasonable time or at all. The client expected PRA to overcome these obstacles and follow the contracted timelines.
Relying on its innovative Service Delivery Model, PRA escalated concerns and took the following actions:
- Replaced the director of project delivery (DPD) and project managers in both Europe and North America to better align with the client’s project needs
- Arranged a meeting between PRA’s executive vice president of Clinical Operations in Europe, the DPD and the client to discuss strategies for improving start-up timelines in Europe
- With oversight from the new DPD and project director (PD), developed an activation and enrollment plan that addressed concerns specific to regions and study design
- Established monthly status meetings between PRA’s and the client’s management teams to discuss potential concerns and focus areas
- Scheduled ongoing meetings between the DPD and the PD to discuss areas of risk and mitigation plans