Enrollment Improved for Phase III Clinical Study
March 10, 2015
Background > Sponsor Partners With PRC Clinical On Phase III Cardiac Study
PRC Clinical supported a biopharmaceutical company headquartered in Palo Alto (CA) to accelerate poor enrollment for two large phase III clinical studies. The company is a leader in cardiovascular medicine focused on the development of novel small molecule therapeutics for the treatment of cardiovascular diseases.
PRC Clinical provided clinical trial project management and clinical site monitoring services to the local sponsor. Additionally, PRC Clinical was trusted to replace a leading CRO to handle clinical site payments. PRC Clinical has over 10 years of clinical payments experience in multinational Phase II and III clinical trials.
Challenge > Sponsor Facing Stagnating Enrollment
PRC Clinical was asked to tackle lagging enrollment for the two large international phase III studies. In order to meet enrollment objectives, PRC Clinical was tasked to source, screen, and select new clinical sites in a short timeline, while providing the sponsor with in-house clinical trial project management and clinical site monitoring.
Solution > Experience, Methodology, And Creativity To On-Board New Clinical Sites
PRC Clinical identified and contacted 70 potential study centers and ultimately brought aboard 35 new study centers into the ongoing program.
Using our internal staff, PRC Clinical developed creative study-specific criteria to re-assess the current enrollment and provide feasibility data to the sponsor. This data resulted in a recommendation to add 35 domestic institutions to the study. Newly identified and selected sites were successful in improving enrollment to meet the corporate goal and timeline.
PRC Clinical Case History > Key Highlights
- In-house project management team to complement sponsors’ team.
- Strong methodology and team effort to find new clinical sites.
- Enrollment objectives met in short timeline.