Comprehensive Clinical Trial Services and Capabilities
From study design to regulatory filings, Versiti Clinical Trials provides tailored solutions to meet your research and development needs.
- Central lab services
- Esoteric testing services
- HLA typing services
- Molecular diagnostics
- Infectious disease testing
- Biomarker development and validation
- Custom assay development/product development
- Companion diagnostic testing
- AAHRPP-accredited IRB services
- Leukopaks
- Non-transfusable/prospective collections
- Collection kit design, assembly and biologistics
- Sample storage and biorepository services
- Specimen handling and site logistics
- Clinical supply provision
- Comprehensive project management
- Study design, feasibility, site identification, qualification and monitoring
- Protocol data management and reporting
- Data management and clinical data reconciliation
- Regulatory authority guidance
- Regulatory strategy and pathway mapping
- Global regulatory filings
- Quality strategy services
- Technical and scientific writing
- Formulation, CMC development and Oversight
Study Design & Site Selection Services
Optimize your Clinical Trial Study Design with expert site selection and monitoring services tailored to ensure trial success from start to finish.
Collection Kits, Biologistics & Clinical Supplies
Versiti offers specimen collection kit design, clinical supplies, and full biologistics support—streamlining trials from site to shipment.
Data & Project Management
At Versiti Clinical Trial Services, we provide dedicated project and data management teams to support your clinical trials from start to finish.
Protocol Writing & Management
Streamline your clinical trial process with Versiti Clinical Trials’ expert protocol writing, management and reporting services, ensuring compliance, accuracy and efficiency.
Vendor & Supplier Management
Explore Versiti Clinical Trial Services’ supplier management services including supplier management and development, technical support, and GxP auditing services.
Biomarker, Assay Development & HLA Typing
Discover Versiti Clinical Trial Services’ biomarker solutions featuring assay design, HLA typing, and immunogenetics to support therapeutic breakthroughs.
Companion Diagnostics
Companion Diagnostic (CDx) assay development to advance therapies with precise, on-time delivery of actionable data for your unique project.
Molecular Diagnostics and Infectious Disease Testing
Versiti delivers precision Molecular Diagnostics and Infectious Disease Testing backed by regulatory expertise and high-throughput capacity.
Formulation, CMC Development, Strategy Services & Oversight
Versiti Clinical Trial Services performs validation and safety testing services for IVD, medical devices, pharmaceuticals, biopharma, assays and equipment.
Regulatory Guidance & Global Filings
Versiti offers expert regulatory strategy and global filing support to accelerate approvals, reduce costs, and ensure compliance worldwide.
Quality Strategy Services
Ensure regulatory readiness and GxP compliance with Versiti’s expert-led validation, auditing, training, and remediation services for clinical research.
Technical & Scientific Writing
Versiti Clinical Trial Services offers expert technical and scientific writing services, ensuring accuracy and clarity in regulatory submissions, clinical trial documentation and more.
Accredited IRB Services
Learn more about Versiti Clinical Trials’ ethical AAHRPP-accredited IRB services with industry-leading review and response times.
Leukapheresis Products
Versiti’s peripheral blood mononuclear cell (PBMC) product is an enriched, fresh leukapheresis product composed of high concentrations of monocytes and lymphocytes, but may also contain lower concentrations of platelets, plasma and red cells.
Starting Materials for Research
As a blood center, Versiti is committed to stewardship of the precious gift that our donors provide. We make products that have expired or are found to be unsuitable for transfusion available to help advance new frontiers in science and medicine.
Request Biomaterials
Order biomaterials and cell therapy starting materials to support your research, further manufacturing and/or commercial purposes.
Prospective Blood Collections
Versiti offers a comprehensive portfolio of high-quality prospective human specimens to accelerate cellular and immune therapy research.