CIBMTR CRO Services for Cell and Gene Therapy

Partner with a CRO team specialized in cell therapy clinical trial design and oversight

Your company is pioneering a new therapeutic modality that could revolutionize care for patients with cancer, autoimmune disorders and genetic disorders. You need a stable, trusted CRO partner that understands the unique needs of a cell therapy clinical trial. And one that can drive a clinical trial execution that is on schedule and within budget.

Our CIBMTR CRO Services set your cell therapy clinical trial up for success and help you mitigate risk.

Our contract research organization team focuses only on cell therapy and hematopoietic stem cell transplant (HSCT) clinical trial design and execution.

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Leverage our years of experience in cell therapy and HSCT trials and correlative study management

years of clinical trials experience

patients and donors enrolled in clinical trials since 2001

active clinical studies in design, enrollment and follow-up

active studies under IND/IDE

NEARLY~

domestic transplant center investigational site partners

Translate complex cell therapy study designs into operational excellence

With a staff trained in the hematology/oncology therapeutic space, we have extensive capabilities to provide a truly customized support package that best fits your needs. Our CIBMTR CRO Services capabilities include:

Protocol development and approvals
Site selection, start-up and management
Study monitoring
Lab and research sample oversight
Patient-reported outcomes

Project management
Database build and data management
Statistics and data analysis
Contracts and financial administration
Medical and safety monitoring

Protocol Development and Approvals

Protocol design
MD oversight and consultation
Clinical Insights
Population analysis
Statistical support
Patient and caregiver consultation

Site Management

Site and personnel qualification, site selection and contracting
Site activation support
Established relationships with nearly 250 transplant/cellular therapy sites
Personalized training and study support
Regulatory document capture, review and storage
Data oversight for completeness and accuracy

Data Management

Electronic Data Capture via Medidata Rave®
Case report form design
Case report form completion guideline design and hosting
Database programming and testing
Data validation, including edit check programming and testing
Randomization and trial supply management
Data aggregation, cleaning, and real-time analytics
Query management and site data quality management
Safety database and laboratory data reconciliation
Data transfer management
Endpoint adjudication support

Immunobiology

Research sample collection tracking and reconciliation
Chain of custody tracking via LabVantage®
Collection/shipping supply ordering and distribution
Development of research sample collection guides and trial operational documents
Sample compliance reporting and analyses
Central biorepository and research laboratory oversight
Central pharmacy contracting and oversight
Access to the NMDP Biorepository for centralized processing and storage of research
samples

Quality of Life

Flexible, multi-modality ePRO system
Surveys conducted electronically, via phone or paper
Multi-language capabilities
Centralized subject outreach and data collection

Safety Event Management

Medical Monitor (MD) services
Data Safety Monitoring Board (DSMB) services
Medical coding to CTCAE, MedDRA®, and WHODrug
System notifications for real-time reporting and regulatory body triage
CDASH compliant deliverables

Project Management

Protocol and study management in compliance with FDA regulations and GCP
Informed Consent Form creation
Site recruitment strategy
Stakeholder coordination
Investigator meetings & trainings
IRB and DSMB submissions and management
Collaboration with RCI BMT Operational teams
Vendor management
Identifying and tracking study milestones, study progress

Study Monitoring

100% Source Data Verification (SDV) or targeted SDV monitoring plans
On-site and remote monitoring
Risk-based monitoring
Transplant/cellular therapy-trained monitors
Site Qualification, Initiation, Interim and Close-out Visits
Site Audit Support

Financial Administration

Expedited site contracting under umbrella of existing Master Study Agreements
Budget creation and tracking
Site and Subject Payments

Biostatistics

Feasibility assessments, trial design and sample size estimation
Statistical Analysis Plan development
Shell tables and figures
Descriptive, univariate and multivariate analyses
Statistical support for regulatory reporting, DSMB, interim and final analyses
Manuscript preparation
CDISC, SDTM and ADaM data formats via proven collaboration with vendor

Logistics

Courier support
KitMaker
Customizable case management

Systems

Medidata Rave® – Electronic Data Capture (EDC)
Medidata Clinical Trials Management System (CTMS)™ – Metrics, issue management and monitoring
Medidata Coder® – Medical coding
Looker™ Business Intelligence Platform – Data analytics
LabVantage® – Biospecimen management
SAS® – Biostatistics and analytics
Florence eBinders™ – Regulatory document filing (electronic Trial Master File) and
tracking with optional site-facing electronic regulatory binders
Asana® Collaboration Work Management Platform – Project management
Electronic Patient Reported Outcomes (ePRO) system that connects Qualtrics with the
Patient Reported Outcomes Measurement Information System (PROMIS) Assessment
Center API and proprietary CIBMTR software

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
Sample management

Benefit from our unique infrastructure and extensive clinical trial site network

Because the CIBMTR is a research affiliation between the National Marrow Donor Program® (NMDP)/Be The Match and the Medical College of Wisconsin, you 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 the NMDP/Be The Match. That means you benefit from the synergies with the 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 single Institutional Review Board (sIRB), dedicated Data Safety Monitoring Board (DSMB), master contracts and 21 CFR part 11 compliant technology

Access to patients and allogeneic donors for research
A direct link to the CIBMTR Outcomes Database with information on more than 575,000 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 on trials, complete site start up faster and expedite processes throughout the duration of the study.

Put our experience and expertise to work for you.

Let’s start with a conversation so we can learn more about your company’s needs.

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Optimize clinical trial protocol design with clinical insight advisors

Our team is driven by our organizational mission—to save more lives through cellular therapy. Our in-house HSCT and cell therapy physicians offer clinical insights to help you optimize your protocol design and lay the groundwork for a successful clinical trial.

Our 70+ person CRO Services team is experienced in cell therapy and HSCT clinical trials.