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Clinical Trial Services

Provides a full spectrum of support for clinical trials in a wide range of diagnostic areas.

Contact Us

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

Known and respected internationally, Versiti‘s Clinical Trial Services provides a full spectrum of support for clinical trials (preclinical and phases I-IV) in a wide range of diagnostic areas, including:

Versiti’s Clinical Trial 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
  • Understanding partner goals
  • Rapid execution of clinical studies

Whether you are a drug, diagnostic or a device company, a CRO or a central lab, the experts at Versiti can help meet your specialty needs.

Clinical Trial Services

  • Pharmaceutical Trials

    Looking for a central lab to perform specialized testing for your clinical trials? BloodCenter is unique in its depth of knowledge, diversity of resources and ability to deliver exceptional value to Sponsors, CROs and Central Labs.

    Services

    BloodCenter of Wisconsin Clinical Trial Services can provide a full spectrum of services for clinical trials (preclinical and phases I-IV) in a wide range of therapeutic areas, including:

    • Specialized laboratory testing
    • Expert medical and technical consultation
    • Custom assay development
    • Specimen collection kits and sample storage
    • Customized reports and electronic data transfers 

     

    Specialized

    • 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

    BloodCenter’s Diagnostic Laboratories take a responsive and collaborative approach, supporting you with:

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

    Comprehensive

    BloodCenter’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, BloodCenter produces the highest quality results.

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

    Looking for a laboratory to evaluate a new medical device or technology? Since 1977, BloodCenter of Wisconsin has 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. 

    Overview

    BloodCenter of Wisconsin Clinical Trial Services offers these services to help evaluate medical devices and laboratory instrumentation:

    •  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

     

    Capabilities

    Clinical Trial Services can provide these 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

  • Custom Assay Development

    Looking for help in developing a novel assay needed for your regulatory approval pathway? The hallmark of the Diagnostic Laboratories at BloodCenter of Wisconsin is innovation. For more than 50 years, we have been translating the latest scientific discoveries into specialized diagnostic testing.

    Overview

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

    • Assay design, development and validation
    • Access to characterized samples
    • Stringent Quality Management Systems

     

    Specialized

    Our Diagnostic Laboratories offer the distinct advantage of BloodCenter of Wisconsin’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

    BloodCenter’s Diagnostic Laboratories take a responsive and collaborative approach, supporting you with:

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

     

    Comprehensive

    BloodCenter’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, BloodCenter produces the highest quality results.

    • Continuous Improvement and Lean Processes
    • CAP, CLIA, AABB, FACT and ASHI accredited
  • Diagnostic Kit Regulatory Studies

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

    Overview

    BloodCenter of Wisconsin 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 BloodCenter of Wisconsin’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

    BloodCenter’s Diagnostic Laboratories take a responsive and collaborative approach, supporting you with:

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

     

    Comprehensive

    BloodCenter’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, BloodCenter produces the highest quality results.

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