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Clinical Trial Services

Expert support for a diverse range of clinical trial needs. Start your trial with Versiti today.

Contact Clinical Trial Team

Contact Us

To Inquire about Clinical Trial Services & Contract Research
Email 800-245-3117 x6250

World renowned experts in blood health innovation collaborate to provide a range of clinical trial services. Versiti’s team is prepared to provide tailored support for preclinical research and all phases of clinical trials.

Expertise across the spectrum of blood health

Versiti Clinical trial Services have assisted pharmaceutical and medical device companies with regulatory studies, laboratory testing, assay development, and a wide variety of other research needs in a wide range of diagnostic areas

Our highly specialized focus in laboratory medicine and blood health provide an ideal foundation for a range of organizations, including contract research organizations (CROs), central laboratories, pharmaceutical companies, multinational organizations, and IVD, biotechnology, and medical device companies.

View Our Comprehensive Test Catalog

Beyond Results

Our Clinical Trial services extend beyond testing to include protocol review, test selection, and interpretation of results, as needed. We offer expert medical and scientific consultation and custom assay development and validation as we strive to fully understand your specific needs to result in the most appropriate, precise, and timely trial structure.

Ready to Begin Your Trial with Versiti?

Service Areas

  • Pharmaceutical Trials

    Versiti’s network of four affiliate blood centers is unique in its depth of knowledge, diversity of resources and ability to deliver exceptional value to Sponsors, CROs and Central Labs

    Services

    Versiti supports a broad range of clinical trial services in the preclinical phase and phases I-IV including, but not limited to:

    Expertise

    • Renowned leaders in esoteric laboratory testing in blood disorder research, testing, and treatment.
    • Thought leaders in in bleeding and clotting disorders, transplantation, cell therapy, and molecular diagnostics.
    • Testing, analysis, and interpretation for more than 300 specialized hematology, oncology, immunology, and molecular assays routinely performed.
       

    Approach

    • Versiti’s responsive and collaborative approach follows proactive steps to understand your goals, provide ongoing communication, and the fastest result turnaround possible.
    • Our comprehensive services extend beyond testing alone to include protocol review, test selection, and the interpretation of results as needed.
    • Available services include expert medical and scientific consultation as well as custom assay development and validation.
    • Our extensive experience in project management ensure a clear path to achieving your clinical trial goals.
       

    Quality Systems

    • With Stringent quality management systems and state-of-the-art facilities, Versiti is able to produce results of the highest quality.
    • We engage in continuous improvement and lean processes 
    • We are CAP, CLIA, AABB, FACT, ASHI, and New York State accredited
  • IVD, Biotechnology, and Medical Device

    Since 1977, Versiti-affiliated blood centers have worked with biomedical and biotech companies for the evaluation of new or modified medical devices related to laboratory instrumentation and the collection, manufacturing and transfusion of blood products. With successful execution and management of 510(k) clinical trials, our clinical research expertise has resulted in FDA regulatory clearance of numerous products.

    Services

    Clinical Trial Services provide specialized testing related to collection, filtering, testing, and storage of blood products (whole blood, platelets, red cell, leukocytes, MNC and plasma). 

    Platelet Studies

    • Cell counts, including residual white blood cells
    • Morphologic and functional platelet test including: hypotonic shock response (HSR), extent of shape change (ESC), morphology, swirling, aggregation, blood gases, lactic acid/ LDH, flow-cytometric measurement of P-Selectin (GMP-140)
    • Platelet Recovery and Survival using chromium-51 and indium-111
       

    Red Cell Studies

    • Spun hematocrit and cell counts, including residual white blood cells
    • Morphologic and functional tests of red blood cells including: morphology score,  ATP, 2,3 - DPG, supernatant (including rejuvenation), hemoglobin, hemolysis, osmotic fragility, blood gases, glucose, sodium, potassium, lactate
    • Red blood cell recovery and survival using chromium-51 and technetium-99m.
       

    Plasma Studies

    • Low range cell counting
    • Supernatant hemoglobin and hemolysis
    • Protein testing
    • Coagulation testing
       

    Custom assays can be developed to accommodate specific protocol requirements.

    Expertise

    We are proud to have extensive expertise in:

    • IRB submissions and review
    • Study design and protocol development support
    • Donor/patient recruitment for clinical studies
    • Integration of study protocols with standard collection processes
    • Medical consultation
  • Blood Products for Research

    Serving biopharma, therapeutic and academic researchers, Versiti provides you with a wide variety of blood products to advance your research in cellular and immune therapies. We offer a variety of traditional and highly unique blood products from well-characterized donors. We also provide a range of apheresis products from normal and mobilized donors, as well as cord blood and cord sera.
     

  • Diagnostic Kit Regulatory Studies

    Developing a diagnostic test for regulatory submission? Versiti has extensive experience working with companies on 510(k) clinical trials for diagnostic applications and evaluation of pre-trial designs.

    Overview

    Our Clinical Trial Services can provide a full range of services for diagnostic kits and medical devices, including:

    • IRB submissions and review
    • Study design and protocol development support
    • Access to characterized samples
    • Medical consultation and Principle Investigator fulfillment

     

    Specialized

    Our Diagnostic Laboratories offer the distinct advantage of Versiti’s rich expertise and experience.

    • Leaders in blood disorder research, testing and treatment
    • Top professionals in bleeding and clotting disorders, transplantation, cell therapy and molecular diagnostics
    • Testing, analysis and interpretation for more than 300 specialized hematology, oncology, immunology and molecular assays 

     

    Responsive

    Our Diagnostic Laboratories take a responsive and collaborative approach, supporting you with:

    • Proactive efforts to understand your goals
    • Ongoing communication
    • Fast result turnaround

     

    Comprehensive

    Versiti’s Clinical and Contract Research services extend beyond testing to include protocol review, test selection and interpretation of results as needed.

    • Expert medical and scientific consultation
    • Custom assay development and validation
    • Extensive experience in project management

     

    Quality Systems

    With stringent quality management systems and state-of-the-art facilities, we produce the highest quality results.

    • Continuous Improvement and Lean Processes
    • CAP, CLIA, AABB, FACT and ASHI accredited

     

  • Custom Assay Development

    For over 50 years, our Diagnostic Laboratories have developed unrivaled experience in translating the latest scientific discoveries into specialized diagnostic testing. 

    Services

    Our Diagnostic Lab experts are highly skilled in an array of technologies including DNA sequencing, gene expression, genotyping, flow cytometry, and ELISA. Whether your project includes testing just a handful of samples or thousands, we are equipped with multiple platforms to reliably meet different throughput requirements. Our team delivers dependable, quality solutions for both preclinical and clinical studies.

    Approach

    Our clinical trial methodology includes proactive processes to understand your goals, rapid and responsive communication, and prompt turnaround times.  Our assay development processes include expert medical and scientific consultation to ensure your project is executed to your desired specifications, following best practices.

Our expertise and dedicated approach to supporting research and clinical trials ensures your unique needs and challenges are met every step of the process. Let Versiti help you achieve you research goals.

For more information about clinical trial services, blood products, and contract research, email LabInfo@bcw.edu or call 800-245-3117 ext. 6250.

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