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.
Leverage our years of experience in cell therapy and HSCT trials and correlative study management
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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 IND/IDE
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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. 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
Our CIBMTR CRO Services capabilities include:
- Physician oversight and clinical insights
- Protocol design for endpoint efficacy
- Expertise in cell and gene therapy
- Population analysis utilizing CIBMTR outcomes data
- Statistical support
- Data Safety Monitoring Board (DSMB) services
- Established relationship with nearly 250 transplant/cellular therapy sites
- Site and personnel qualification
- Site selection and contracting
- Site activation support
- Personalized training
- Regulatory document capture, review and storage
- Data oversight for completeness and accuracy
- Electronic Data Capture via Veeva or Medidata Rave®
- Case report form (CRF) design
- 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
- Access to the NMDP Biorepository for centralized processing and storage of research
- Research sample collection tracking and reconciliation
- Chain of custody tracking via LabVantage®
- Collection/shipping supply orders and distribution
- Development of research sample collection guides and trial operational documents
- Sample compliance reporting and analyses
- Central biorepository, pharmacy and research laboratory oversight
- Flexible multi-modality ePRO system
- Surveys conducted electronically, by phone or by paper
- Multi-language capabilities
- Centralized subject outreach and data collection
- Medical Monitor (MD physician) services
- (DSMB) services
- Medical coding to CTCAE, MedDRA® and WHODrug
- System notifications for real-time reporting and regulatory body triage
- CDASH compliant deliverables
- Protocol and study management in compliance with FDA regulations and Good Clinical Practice (GCP)
- Informed Consent Form creation
- Site recruitment strategy
- Stakeholder coordination
- Investigator meetings and trainings
- IRB and Data Safety Monitoring Board (DSMB) submissions and management
- Vendor management
- Study milestone tracking
- Formal risk-management planning and mitigation
- Cell and gene therapy-trained monitors
- Risk-based monitoring
- 100% Source Data Verification (SDV) or targeted SDV monitoring plans
- On-site and remote monitoring capabilities
- Site qualification, initiation, interim and close-out visits
- Site audit support
- Expedited site contracting under umbrella of existing Master Study Agreements
- Budget creation and tracking
- Site and subject payments
- 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 deliverables (SDTM, ADaM, Define) via proven collaboration with vendor
- Courier support
- KitMaker research sample kits
- Customizable case management
- Central Pharmacy coordination
- Randomization and Trial Supply Management
- Veeva Vault: Electronic data capture
- Veeva Vault Clinical Trial Management System (CTMS): Metrics, risk and issue management and monitoring
- Veeva Vault electronic Trial Master File (eTMF): Regulatory document filing, tracking and QC
- Medidata Rave: Electronic data capture (EDC)
- Florence eBinders™: Regulatory document filing (electronic Trial Master File) and tracking with optional site-facing electronic regulatory binders
- Electronic Patient Reported Outcomes (ePRO)
- Looker™ Business Intelligence Platform: – Data analytics
- LabVantage®: – Biospecimen management
- SAS®: – Biostatistics and analytics
- Asana® Collaboration Work Management Platform: – Project management
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, 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 NMDP. That means you 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 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.
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 80+ person CRO Services team is experienced in cell therapy and HSCT clinical trials.
CIBMTR CRO Services Leadership and Medical Team
Steven Devine, MD
Chief Medical Officer
NMDP
Senior Scientific Director CIBMTR NMDP
Jeffery Auletta, MD
Senior Vice President, Patient Outcomes and Experience NMDP
Chief Scientific Director
CIBMTR NMDP
Heather Stefanski, MD, PhD
Vice President, CIBMTR and Clinical Services
NMDP
Scientific Director of Donor Health & Safety Working Committee
CIBMTR NMDP
Erin Leckrone
Vice President, Clinical Trials
Access additional services for allogeneic cell therapy developers
Bioinformatics Consulting
Access data-driven insights to help you define your targets, build your allogeneic cell bank and manage risk throughout cell therapy development.
Allogeneic Cell Sourcing
Source high-quality adult donors that match your therapy needs and receive end-to-end support from donor identification through cell delivery.
Cord Blood Unit Sourcing
Get comprehensive visibility and streamlined access to the fully characterized domestic cord blood unit inventory.
We’re ready to connect with you
Let’s discuss your needs and how our CIBMTR CRO Services professionals can support your cell and gene therapy trials.