Access to Biospecimens, Patient Data, and Researchers from Mayo Clinic

 

We provide 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 and well-annotated data
  • Retrospective studies: Clinical residual samples and archived samples

 

ANALYTICAL VALIDATION

Assistance 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.  Common tasks include budget compilation, facilitation of scientific interactions, contract negotiations, and status updates.

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.

We offer 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.