Research Study Planning & Optimization
Intelligently designed protocols and study plans optimize efficiency, efficacy, and safety. Likewise, experimental designs minimize study attrition or other pitfalls to achieve your project objectives.
Our experts will guide you in effective decision-making for HCT, other cellular therapy, and gene therapy studies.
Our services include:
- Protocol design or review
- Statistical support
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Regulatory Consulting
Our team includes experts in all aspects of HCT, other cellular therapies, and gene therapies. We will leverage years of direct patient care experience and unparalleled insights from more than >1,800 publications and ~200 ongoing studies and clinical trials.
Our services include:
- Support services for managing regulatory obligations.
- Expertise in providing reports, consultations, and other services to address regulatory requirements and navigate and respond to evolving needs and requests.
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Real-World Data
Harness robust data for your studies with the most comprehensive real-world data available for patients receiving HCT, other cellular therapies, and gene therapies in the US.
Our experts apply real-world solutions to further the research field, propelling us forward to improve patient care and outcomes while supporting our corporate partners.
Our services include:
- Retrospective or prospective data collection
- Custom de-identified datasets
- Patient-reported outcomes | Our researchers design studies that continuously assess how to improve patient-provider communication, assist with clinical decision-making, improve patient satisfaction, enhance patient outcomes, and ensure a better quality of care from a healthcare system perspective
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Real-World Evidence
If you're seeking robust solutions regarding the usage and benefits of your product, our experts can support your efforts by designing custom solutions to assess your product's potential benefits or risks!
Our services include:
- Observational clinical studies
- Post-authorization studies | Regulatory agencies require a post-authorization study at the time of approval. Our project designs help you assure continued safety, effectiveness, and risk identification
- Study planning and design
- Accrual and analysis reports
- Sample collection and biorepository services
- Control arms and contemporaneous control cohorts
- Matched controls
- Cross-sectional and longitudinal studies
- Landmark analyses
- Retrospective and prospective study reports
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Corporate Membership Program
Choose valuable benefits from five different membership levels, including access to the most comprehensive blood and bone marrow transplantation information and additional specialized corporate services to meet your project objectives.
Access Corporate Membership Program resources today!
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Clinical Research Organization Services (CRO Services)
Trust our dedicated clinical research organization (CRO) team to partner with you on cell therapy clinical trial design and oversight.
Our experienced CRO Services team understands the unique and complex needs of cell therapy and hematopoietic clinical trials, including end-to-end trial design, operations, and logistics support. We provide our partners with access to CIBMTR's Outcomes Database, with information on more than 675,000 patients; and more than 200 active investigational transplant center sites in our clinical trials network. In 20+ years, our hematologic / oncologic staff members have worked on trials involving more than 45,000 patients and donors. Choose full clinical trial support or specific services to fill in the gaps– including support with patient-supported outcomes, site selection and management, and sample logistics.
Let our CRO Services team provide the guidance and support you need to help your clinical trial succeed – on schedule and on budget.
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Bioinformatics Consulting
Translate science into operations to optimize your cell therapy development strategy.
Tap into our experts for models, analyses, and interpretations as you plan for cell therapy development and clinical trials.
We support you through the research and planning stages of therapy development with data and analytical expertise to help you define targets and build your allogeneic off-the-shelf cell bank. Rely on our expertise to optimize donor choices and target patient population coverage; identify and compare optimal cell sources; resolve HLA data ambiguities and gaps while harmonizing the data for research studies; identify favorable factors of histocompatibility and HLA / KIR genotype interpretation; project match likelihoods; and optimize cell source type, high potential genotypes, and sample size.
Our team provides real-time access to unique and expansive clinical outcomes, CIBMTR data, and donor registry databases available only through our organization. You’ll get insightful data analytics and customized modeling based on decades of cell therapy research.
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