CIBMTR® CRO Services for Cell and Gene Therapy

Expertise and experience to successfully lead cell therapy clinical trial execution.

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CIBMTR® CRO Services for Cell and Gene Therapy

Expertise and experience to successfully lead cell therapy clinical trial execution.

A clinical research organization (CRO) team specialized in cell therapy

A company pioneering a new therapeutic modality needs a stable, trusted CRO partner that understands the unique needs of a cell therapy clinical trial. Equally important, it must be able to drive a clinical trial execution that is on schedule and within budget.

CIBMTR CRO Services set cell therapy clinical trials up for success and help mitigate risk. Our CRO team focuses only on cell therapy and hematopoietic stem cell transplant (HSCT) clinical trial design and execution, providing the specialized expertise cell and gene therapy developers need.

A history of advancing cell therapies

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+
years of clinical trials experience
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+
patients and donors enrolled in clinical trials since 2001
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active clinical studies in design, enrollment and follow-up
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active studies under investigational new drug (IND) or investigational drug exemption (IDE) authorization from the US Food and Drug Administration
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domestic transplant center investigational site partners

Translate complex cell therapy study designs into operational excellence

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With a staff trained in the hematology/oncology therapeutic space, we have extensive capabilities to provide a truly customized support package. Partners can choose full clinical trial support or contract with our team to fill a gap in specific services, such as support with surveys, site selection and management, or sample management.

Our CIBMTR CRO Services capabilities include:

  • Protocol development and approvals
  • Site management
  • Data management
  • Immunobiology
  • Patient-reported outcomes
  • Safety event management
  • Project management
  • Contract and financial monitoring

Benefit from our unique infrastructure and extensive clinical trial site network

Because the CIBMTR is a research affiliation between NMDP℠ and the Medical College of Wisconsin, our partners can leverage a powerhouse of support and the established infrastructure and stability that goes along with it.

We are both a sponsor running our own clinical trials and a CRO running trials for other organizations. Our research organization is embedded within the operations of NMDP. That means our partners benefit from the synergies with NMDP and NMDP BioTherapies℠ for:

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End-to-end clinical trial design, operations and logistics support

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Built-out clinical infrastructure with single Institutional Review Board (sIRB), dedicated Data Safety Monitoring Board (DSMB), master contracts and 21 CFR part 11 compliant technology

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Access to patients and allogeneic donors for research

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A direct link to the CIBMTR Outcomes Database with information on more than 700,000 patients

Active investigational transplant center sites in our clinical trials network

We harness established relationships with a contracted network of nearly 250 investigational transplant center sites as well as donor center and research lab partners across the United States.

Our established relationships and contracts with investigational sites allow us to successfully recruit sites to participate in trials, complete site start up faster and expedite processes throughout the duration of the study.

A U.S. map with markers representing locations of investigational transplant center sites.

Active investigational transplant center sites in our clinical trials network

We harness established relationships with a contracted network of nearly 250 investigational transplant center sites as well as donor center and research lab partners across the United States.

Our established relationships and contracts with investigational sites allow us to successfully recruit sites to participate in trials, complete site start up faster and expedite processes throughout the duration of the study.

Learn more about CIBMTR

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How allogeneic cell therapy developers can benefit from using a combination of CIBMTR Bioinformatics Consulting, CIBMTR CRO Services and Cell Sourcing solutions from NMDP BioTherapies

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Collecting Data from Multiple Study Sites

We’re ready to connect

Find out how our CIBMTR CRO Services professionals can support your cell and gene therapy trials.