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.



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


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 design
  • MD oversight and consultation
  • Clinical Insights
  • Population analysis
  • Statistical support
  • Patient and caregiver consultation
  • 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
  • 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
  • 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
  • Flexible, multi-modality ePRO system
  • Surveys conducted electronically, via phone or paper
  • Multi-language capabilities
  • Centralized subject outreach and data collection
  • 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
  • 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
  • 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
  • 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, SDTM and ADaM data formats via proven collaboration with vendor
  • Courier support
  • KitMaker
  • Customizable case management
  • 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

CRO map

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

CIBMTR CRO Services Leadership and Medical Team

Erin Leckrone

Erin Leckrone

Senior Director, Clinical Trials

Lisa Erickson

Senior Manager, Clinical Project Management

Kathleen Kane Headshot

Kathleen Kane

Senior Manager, Clinical Operations

Kelsey Schertz Headshot

Kelsey Schertz

Manager, Clinical Data Management

Caitrin Bupp Headshot

Caitrin Bupp

Manager, Biostatistics

Alisha Mussette Image

Alisha Mussetter

Manager, Clinical Monitoring Operations

Danielle O’Donnell Vitali

Danielle O’Donnell Vitali

Manager, Clinical Operations

Ashley Spahn Headshot

Ashley Spahn

Manager, Clinical Sample Management

Deb Mattila headshot

Deborah Mattila

Manager, Survey Research

Kayla Christianson

Kayla Christianson

Supervisor, Clinical Operations

Steven Devine, MD Chief Medical Officer Senior Scientific Director

Steven Devine, MD

Chief Medical Officer NMDP/Be The Match

Senior Scientific Director CIBMTR NMDP

Jeffery Auletta

Jeffery Auletta, MD

Senior Vice President, Patient Outcomes and Experience NMDP/Be The Match

Chief Scientific Director CIBMTR NMDP

Heather Stefanski, MD, PhD Vice President, Medical Services

Heather Stefanski, MD, PhD

Vice President, Medical Services NMDP/Be The Match

Scientific Director of Donor Health & Safety Working Committee CIBMTR NMDP

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

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.

Collection Network Onboarding

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.