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Expanded service offering specializes in the design, implementation and oversight of cellular therapy clinical trials.
January 18, 2023
By: Tim Wright
Editor-in-Chief, Contract Pharma
Be The Match BioTherapies, an organization offering solutions for companies developing and commercializing cell and gene therapies, is offering CIBMTR (Center for International Blood and Marrow Transplant Research) clinical research organization (CRO) services, which allows sponsors to reduce the time required to launch and execute clinical trials. These CRO services are a collaborative effort between Be The Match BioTherapies and the CIBMTR, resulting in unique expertise and access to resources, including research, sites, donors, partnerships, and scientific and operational expertise. “Be The Match BioTherapies and its partners have successfully supported bone marrow transplant and cellular therapy clinical trials for nearly 20 years,” said Erin Leckrone, senior firector, clinical trials, at the CIBMTR. “Today, with our formal launch of CIBMTR CRO Services, the expertise and resources honed over decades of work by the leading experts are accessible to small to mid-sized biotechnology companies. These services, whether used in whole or as ad hoc support, will accelerate time-to-trial and bridge the transition from research to patients.” CIBMTR CRO services offer unique capabilities including: • Nearly 20 years of experience in transplant and cellular therapy trials and correlative study management, including therapeutically trained staff. • Established relationship with more than 225 domestic clinical sites. • Access to direct contact with patients and donors for research and clinical insights through on-staff transplant physicians. • Synergies with National Marrow Donor Program/Be The Match (NMDP/Be The Match) and Be The Match Biotherapies for end-to-end clinical trial design, operations, and logistics support. • Built-out clinical infrastructure with a single Institutional Review Board (sIRB), dedicated Data Safety Monitoring Board (DSMB), master contracts, and 21 CFR part 11 compliant software. • A direct link to the CIBMTR outcomes database for more than 575,000 patients. The new CRO services provide turn-key solutions, including protocol development and approval oversight, project management, site selection, site start-up, data management, research sample/laboratory coordination, study monitoring, statistical analysis, patient-reported outcomes, and financial administration. Alternatively, companies can leverage the expertise of CIBMTR CRO Services for select services such as data analysis, surveys, site selection and management, and sample management.
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