Premier Research recently managed two Phase 2/3 Chronic Myeloid Leukemia trials for which we were recognized as the “Clinical Research Team of the Year” at the 2008 GCPj Awards.
These studies carried a unique set of challenges including targeting an uncommon subset patient population which greatly affected recruitment and the collection and evaluation of complicated genetic and molecular data.
To best support the studies, our experienced team covering nine time zones was led by a global director with bilateral project management in North America and Europe and team members in each country of the participating major cancer centers. Through proactive planning and continuous feedback, our team engaged the sites and provided innovative solutions completing all of the tasks and exceeding the client’s expectations.
Our monitoring group worked with many of the centers to develop best-practices across the sites to integrate the use of their electronic systems with clinical trial documentation requirements. These interactions improved standards in busy centers making a significant impact on the future of clinical data and maintaining compliance with ICH/GCP guidelines.