With over a dozen hematology-trained specialists located worldwide, Parexel team supports clinical trials from first-in-human to post-registration studies in benign conditions and hematologic malignancies. Our group has expertise in studies involving targeted therapies, immune-oncology, cell and gene therapy, and bone marrow transplantation. Our hematologists work with you on study design, protocol writing, safety monitoring, data review and analysis, regulatory, and other strategies, including high-quality medical monitoring.
As an example of our work, one project involved dose escalation and expansion in a Phase I solid tumor study. Stringent inclusion/exclusion criteria, along with the need to find patients with a specific gene mutation, posed steep challenges in a competitive environment. The study involved a complex protocol, with a four-week screening period for each of four cohorts and overlap for each dose-level group, and storage and transportation of biopsy and tumor samples. Yet we successfully enrolled all cohorts and managed integrated logistics, with last-patient-first-visit 16 days ahead of target. Our site alliance network was instrumental to this effort.
In the past five years, we have conducted 240+ hematology clinical projects and enrolled 35,000 patients.