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CIBMTR Clinical Research Organization Services (CRO Services), formerly known as the Resource for Clinical Investigations in Blood and Marrow Transplantation (RCI BMT), supports trials of all phases, with specific expertise in Phase I and Phase II trials. Offering full CRO Clinical Research Organization (CRO) capabilities, we specialize in the design and oversight of hematopoietic cell transplantation (HCT) and other cellular therapy clinical trials, with a focus on collaboration with organizations for the highest-impact clinical trials.

With a passionate team of dedicated staff and a large network of investigational sites and partners, we offer a variety of capabilities that can be used as a whole or based on a single need. Our collaborative nature has ensured the successful execution of industry and academic studies and given many patients access to life-saving treatments.

Benefits of Working with CRO Services

  • Years of industry and academic experience in transplant and other cellular therapy trials and correlative study management
  • An established relationship with a large network of centers
  • Access to direct contact with patients and donors for research
  • Synergies with NMDP and NMDP Biotherapies for allogeneic cell sourcing; autologous supply chain management; and collection network onboarding, auditing, and ongoing management
  • Built-out clinical infrastructure with single Institutional Review Board (sIRB), dedicated Data Safety Monitoring Board (DSMB), master contracts, and 21 CFR 11 compliant technology
  • Direct link to the CIBMTR outcomes database for >675,000 patients for historical control analysis and real-time comparison of patient populations by center

Capabilities

  • Protocol development and approvals
  • Physician consultation and expertise for study design
  • Clinical project management
  • Site selection and start-up
  • Regulatory document oversight in eTMF 
  • Database build
  • Data management
  • Patient-reported outcomes
  • Study monitoring (onsite and remote)
  • Medical monitoring 
  • Safety event oversight
  • Statistics and data analysis
  • Laboratory and research sample oversight
  • Contracts and financial administration
  • Regulatory oversight

Contact Us

We are ready to connect with you to support your clinical trial needs. Contact us to learn how our CRO Services professionals can support your transplant and cell and gene therapy trials.

Jeffery J. Auletta, MD
Scientific Director, CIBMTR CRO Services
Chief Scientific Director, CIBMTR NMDP

Erin Leckrone
Senior Director, Clinical Trials
CIBMTR NMDP

Contact Us

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