Clinical Trial Design

World-renowned expertise in the design and management of cell therapy clinical trials

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The development of your cell or gene therapy depends on properly-executed clinical trials, designed to derive statistically significant results. Through our global research partnership with the CIBMTR® (Center for International Blood and Marrow Transplant Research®) our research experts support clinical research efforts of all sizes.

For more than 20 years, our physicians, scientists, biostatisticians and project managers have specialized in helping research teams design, optimize, execute and validate a wide range of clinical programs—from single-site, investigator-led trials to broad, multi-center prospective cell and gene therapy trials. By leveraging the world’s largest database of stem cell transplant patient outcomes, your expertly-designed clinical trial will deliver verifiable, reproducible results.

Our clinical trial design and management capabilities include:
  • Recruitment and management of trial sites, through our network of apheresis, cell collection and transplant centers
  • Expert project management to oversee on-time and on-budget study and participant recruitment and execution
  • Correlative study sample collection, processing, storage and testing support
  • Clinical, scientific, and statistical consultation and/or support led by physicians, scientists and biostatisticians
  • Regulatory support to ensure compliance with necessary FDA and/or global regulations
  • Delivery and logistical support for investigational products

Access M.D., Ph.D., and M.S.-level experts in clinical cellular therapy, immunobiology, bioinformatics and biostatistics who conduct practice-changing research. Dr. Mary Horowitz and her team have opened more than 22 clinical trials through RCI BMT that have accrued more than 37,000 patients, and 50 clinical trials through the BMT CTN with more than 10,000 patients accrued to date.