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Histopathology Research Laboratory

A dedicated and GLP-compliant preclinical contract research organization serving to support industry and academia in the development of novel devices and therapeutics. Alizée's team is comprised of ACVP boarded Pathologists, PhDs, MDs and highly trained technicians who are focused on delivering clear, reproducible, and contextual results.

Integrity: Scientific & Professional


Your success is our success

Our process is designed to facilitate informed histology, driven by thoughtful and intelligent evaluation strategy to maximize the data gleaned from each endpoint. Timeliness and clarity of results enable you to make informed decisions regarding your program. Additionally, our metered evaluation approach ensures we provide the best and most comprehensive evaluation package from each sacrificed life and each dollar spent without hidden or unexpected costs.

How our process works

  • Initial discussion or request for proposal
  • Alizee assigns a Principal Investigator, Project Manager and team of specialists to inform and advise the scope of work.
  • Our team works in collaborative partnership with you to develop the histopathology strategy specific to your objectives
  • Issuance of Alizée's estimate

Quality


Continuous Quality Improvements

A highly integrated and constantly updated quality system led by our Quality Assurance Unit keeps our facility and your study compliant with regulations including newly issued guidance documents. Our evaluations are perfectly suited to fulfill and exceed ISO guidelines. A history of Alizée's support on successful filings and multiple "no-findings" FDA facility audits speak to our continuous improvements and strict GLP practices.

Innovation

Our "boutique laboratory" approach and methodologies are customized to each project. Agility of mind and flexibility of resources adapt our non-clinical evaluation of medical devices, drugs, biologics and biomaterials.

Capabilities

  • Necropsy

    1. Prosecting services
    2. Board-certified veterinary pathologist oversight
  • Histology

    1. Macroscopic analysis, tissue trimming, fixation and processing.
    2. A range of embedding media may be employed including paraffin, plastic resins and optimal cutting temperature (OCT; frozen sections) dependent on the therapeutic, or device specifications.
    3. Primary evaluation via polychromic staining for general response provides semi-quantitative and qualitative scoring of microscopic changes.
    4. Targeted assessment is subsequently performed using special stains or immunohistochemistry to illuminate specific changes and allow for quantifiable metrics to be gathered.
    5. Quantitative imaging analytics elucidate pathological findings and reveal trends.
  • Clear, Concise and Meaningful Reporting

    1. Executive summary reporting for pilot or feasibility studies/early stage development.
    2. Comprehensive illustrated Pathology Reports thoroughly detailed and complete with contextual interpretation to provide strength and clinical relevance to regulatory submission packages.