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Mayo Validation Support Services
  • About
  • Collaboration
  • Sample Testing
  • Trial Support

Mayo Validation Support Services (MVSS) is a service line within Mayo Clinic's Department of Laboratory Medicine and Pathology. MVSS facilitates collaborations between Mayo Clinic scientists and industry or academic partners related to clinical validations, acquisition of biospecimens, laboratory testing to support clinical trials, or the validation of new technologies.

Mayo Clinic's integrated practice of medicine, large patient populations, and associated medical data provide opportunities to access information on numerous disease states and conditions, which can support various research needs. MVSS coordinates these research interactions with clients.

MVSS provides comprehensive research support, including project management and patient enrollment, as well as data teams that analyze Mayo Clinic's vast repository of patient information to identify eligible research candidates and specimens.

Biospecimen Acquisition

Biospecimens available for collaborative research may include tissue (fresh, frozen, FFPE), blood, stool, or urine.

  • Prospective Studies
    • Patient Consent/Enrollment
    • Well Annotated data
  • Retrospective Studies
    • Clinical Residual Samples
    • Archived Samples

Analytical Validation

MVSS assists with validation studies involving sensitivity, specificity, accuracy, precision, and reference ranges. Potential projects include:

  • Reproducibility Studies
  • New Test Development
  • Comparison Testing
  • Device/Diagnostic Validation

Project Management and Regulatory Compliance

  • A project manager is assigned to coordinate the project from initial inquiry to closeout.
  • Coordination with Mayo Clinic's Institutional Review Board (IRB) ensures every collaboration will meet or exceed both Mayo Clinic's prevailing patient protection, consent, and privacy standards, as well as other regulatory bodies' standards.
  • MVSS offers access to Mayo Clinic resources that provide clinical performance data in support of a client's 510(k) or new drug application (NDA) submission.

Next Steps

  • Prospective client provides a project summary with scientific aims.
  • MVSS identifies a Mayo Clinic primary investigator to participate in the project.
  • Confidentiality agreement is executed, if desired.
  • Study protocol is defined by MVSS
  • MVSS creates a budget to support project efforts.
  • Contract is executed.
  • Approvals by IRB and ancillary committees obtained, if needed.
  • Collaborative project begins.

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Mayo Validation Support Services

MVSS has the ability to test previously collected or archived research samples. For specimens outside of validated stability, necessary approvals from the performing laboratory will be obtained.

Access to More Than 3,000 Tests

Mayo Medical Laboratories provides laboratory testing to support health care systems, hospitals, specialty clinics, and other clinical laboratories. This same comprehensive menu is available for research samples.

Project Management and Contract Formulation

  • A project manager is assigned to coordinate the project from initial inquiry to closeout.
  • Each project receives a customized laboratory services agreement (LSA) outlining the responsibilities or obligations of each party, as well as legal terms governing the service.

Next Steps

  • Client identifies laboratory tests to be performed.
  • MVSS will provide a bid for performing identified tests.
  • A contract is formulated and signed.
  • Operational setup and processing are reviewed.
  • Test results are reported.

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Mayo Validation Support Services

MVSS can facilitate testing and resulting of samples from clinical trials through Mayo Clinic's Department of Laboratory Medicine and Pathology. All of the laboratories within this department hold accreditations with the College of American Pathologists (CAP) and licensures with Clinical Laboratory Improvement Amendments (CLIA), both of which ensure the highest level of quality and standardization.

Within clinical trials support services, MVSS' role is to perform testing and provide results. MVSS does not provide additional data-management services typically associated with the role of a central laboratory.

Customized Contracting and Project Management

  • Each project receives a customized laboratory services agreement LSA outlining the responsibilities or obligations of each party, as well as legal terms governing the service.
  • A project manager is assigned to coordinate the project from initial inquiry to closeout.

Comprehensive Test Menu to Support Trial Goals

MVSS holds a close partnership with Mayo Medical Laboratories, which enables access to more than 3,000 tests to support a client's clinical trial.


Next Steps

  • Client selects laboratory tests that will support trial.
  • MVSS will provide a bid for performing selected tests.
  • A contract is formulated and signed.
  • Operational setup and processing are reviewed.
  • Test results are reported.

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Mayo Validation Support Services

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