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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.

Blood Test Tubes and Cenetron Logo

Research Logistics with Cenetron

Whether academic studies or a cutting-edge clinical trial, research projects demand logistics and custom solutions from Cenetron that get it right the first time, on time, every time.

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IRB Services with Salus

An AAHRPP-accredited IRB, Salus IRB is committed to the highest standards in human research protection while providing quick, consultative service and expertise with over 30 years experience.

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See Our Newest Test Addition

  • Thrombin Generation Assay

    The Versiti Diagnostic Labs Thrombin Generation Assay (TGA) measures the overall potential of a plasma sample to produce thrombin. TGA is a global assay, and is a more effective method for assessing the potential for a plasma sample to coagulate, as compared to measurements using clotting assay such as PT or a aPTT or individual factor assays.1 TGA uses a flurorescent endpoint that is not interfered with by the formation of a clot. This allows for a more physiologically relevant measurement of thrombin generation over time.2

    For additional test information, contact Versiti Clinical Trial Services Office: 1-800-245-3117 x 6250, Labinfo@versiti.org.

    Test Information

    • Additional Sample Requirements: Processing Instructions (Hemostasis Processing)
    • Shipping Information: Ship Frozen. Samples should be shipped on a minimum of 5 pounds of dry ice.
    • Volume Requested: Minimum of 600 µL. 1000 µL preferred.
    • Method: Calibrated Automated Thombogram (CAT)

    Ordering Information

    To order contact Versiti Clinical Trial Services Office: 1-800-245-3117 x 6250, Labinfo@versiti.org. Order code: 1980

For global determination of thrombin in plasma.

*For research use only. Not for use in diagnostic procedures.

1 Lance, M.D. A general review of major coagulation assays: thromboelastography, thrombin generation test and clot waveform analysis. Thrombosis Journal 2015; 13:1

2 Tripodi, A. Thrombin generation assay and its application in the clinical laboratory. Cl in Chem 2016; 62(5): 699-707

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


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


    • 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.


    • 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.


    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.


    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.


    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



    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 



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

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



    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. 


    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.


    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@versiti.org or call 800-245-3117 ext. 6250.


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