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Clinical & Translational Research Core

Clinical & Translational Research Core

The clinical research infrastructure at the Wyss Institute facilitates informed and accelerated product development. Human clinical studies are a unique and critical facet of the Institute and, together with animal studies, are central to our technology development and translational efforts. We have vast ongoing clinical research efforts, with more than 50 active human and preclinical/non-human subjects research studies.

Our clinical research team supports the clinical studies at the Institute and across our collaborating institutions, ensuring compliance with Good Clinical Practice and other applicable federal and university regulations. The team is the central liaison between study personnel, participants, the Institutional Review Board (IRB), and the Committee on Microbiological Safety (COMS). Our staff also provide assistance with study design, protocol implementation, coordination, training on clinical protocols, data collection, participant enrollment and maintenance of study documentation and files. These capabilities are a driving force for the successful translation of research and laboratory innovations at the Wyss Institute.

Similar to human clinical trials, the Institute recognizes that pre-clinical animal work is equally important. Our pre-clinical animal resources include consultation in study design, direct veterinary and technical support, and species-specific training in experimental techniques. The infrastructure of the Wyss Institute ensures that animals are used judiciously and that their role in science is refined, and well-reasoned. Consistent with the 3R’s (replacement, reduction and refinement) of animals in research, the Wyss champions technologies that one day could become alternatives to the use of animals for scientific purposes.

What we offer

The Wyss Institute's Clinical and Translational Research Core (CTRC) provides the following resources: clinical research, pre-clinical and animal work, biosafety and lab safety.

Contact: CTRC@wyss.harvard.edu

  • Clinical Research Team

    • New study start-up
    • Protocol writing and consultation
    • Project management and protocol implementation
    • Regulatory compliance and study coordination support
    • Data and sample collection
    • Institutional review board submissions (full board, exempt, continuing reviews, amendments/modifications, not human subjects research applications)
    • Cede and catalyst submissions
    • Audit preparation and internal audits
    • Committee on Microbiological Safety (COMS), submission and study administration assistance

    Useful links:

    The Clinical Research Team also offers statistical support, which includes study design, performing statistical power calculations, drafting analysis plans and analyzing data, preparing and interpreting study results, developing reports, data coding, cleaning and management, assisting with writing statistical portions of grants, manuscripts, protocols and presentations.

    Contact: clinicalresearch@wyss.harvard.edu

  • Veterinary Team

    • IACUC Protocol Design and Model Implementation
    • IACUC Protocol Management
    • Surgical Support/Post-Operative Care
    • Imaging Support
    • Animal Husbandry Support
    • Breeding Colony Support
    • Controlled Substance Program
    • Hands-on Training for Researchers
      • Basic handling and restraint, Injections (SQ, IP, IV), Oral Gavage, Blood draw, Breeding colony maintenance, Euthanasia, Necropsy, Anesthesia, Aseptic technique and tissue handling, Major and minor surgeries by request.

    Useful forms:

    Contact: amanda.graveline@wyss.harvard.edu

  • Biosafety and Lab Safety

    • COMS support
    • Microbiological Consultation and Risk Assessments
    • Hazardous Materials Management
    • Chemical Safety
    • Trainings
    • Waste Management
    • Process & Equipment Assessments
    • Chemical Safety
    • General Lab Safety
    • Fire and Life Safety
    • Emergency Planning and Response
  • Resources

Learn More About Our Clinical Research Studies

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