PRA Successfully Rescues Phase II Hematology Study

PRA was selected to take over a Phase II hematology study from another CRO. The project had missed start-up milestones, and the client was dissatisfied with the previous CRO’s site management.

Certain challenges are inherent to rescue studies, particularly at the beginning of the trial process. A timely transition is critical to recover from start-up delays that were incurred prior to rescue, as well as to reduce duplicate payments for the client. In this case, obtaining the necessary information and start-up documentation from the previous CRO was particularly challenging. PRA needed to implement and update our systems quickly to be able to fully assess the project’s status. Finally, recruiting patients for a rare disease with relatively few patients requires carefully planned enrollment strategies.

PRA developed a comprehensive plan to guide all aspects of the transition. The plan included risk mitigation measures, transition pathways for each functional area and a detailed schedule of meetings. These meetings covered each applicable functional area to ensure that specialists from each group were involved in discussions. For example, the assigned PRA clinical team members organized calls with CRAs from the previous CRO in all study countries and in some cases conducted co-monitoring visits.