Be The Match BioTherapies Launches CRO Services for Cell and Gene Therapy

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In the Lab eNewsletter, Pharmaceutical Technology's In the Lab eNewsletter, February 2023, Volume 18, Issue 2

Be the Match BioTherapies’ and CIBMTR’s expanded service offering is intended to aid in the design, implementation, and oversight of cellular therapy clinical trials.

Be The Match BioTherapies, a provider of solutions for developing and commercializing cell and gene therapies, in conjunction with the Center for International Blood and Marrow Transplant Research (CIBMTR), is offering expanded clinical research organization (CRO) services. These services are designed to help companies reduce the time required to launch and execute clinical trials.

According to a Jan. 17, 2023 company press release, 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. Companies also have the option to only choose select services, including data analysis, surveys, site selection and management, and sample management.

The CRO services feature built-out clinical infrastructure, including a single institutional review board, a dedicated data safety monitoring board, master contracts, and 21 CFR part 11 compliant software. Customers will also gain a direct link to the CIBMTR outcomes database, consisting of data from more than 575,000 patients.

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“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 director, Clinical Trials, CIBMTR, in the release. “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.”

Source: Be the Match BioTherapies