Anatomic Pathology/Clinical Pathology

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Anatomic Pathology/Clinical Pathology 2017-07-26T11:22:27+00:00

Anatomic Pathology / Clinical Pathology

Common Challenges in Evaluating the Reproductive System in Nonclinical General Toxicology Studies

According to the ICH Harmonised Tripartite Guideline: Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals M3(R2), both men and women of child bearing potential (WoCBP) can be included in Phase I and II trials before the conduct of the male and female nonclinical fertility studies, since an evaluation of the male and female reproductive organs is performed in the repeat-dose toxicity studies. As such, much of the early assessment of potential test article-related effects on the reproductive system falls on the nonclinical toxicologic pathologist.

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Research programs require critical and accurate assessments of pathology endpoints to characterize safety and provide support for human clinical trials. MPI Research performs integrated and comprehensive pathology evaluations by an experienced staff of board-certified veterinary anatomic and clinical pathologists who are recognized as scientific leaders in the field of toxicologic pathology. Our highly trained technical and support staff ensure the accurate collection and processing of specimens with efficient reporting of data while maintaining the flexibility to adapt as needs evolve. MPI Research is experienced, knowledgeable, and ready to meet your needs by providing

  • 18 anatomic and 3 clinical pathologists, all of whom are board-certified by the American College of Veterinary Pathologists (DACVP)
  • Four GLP-compliant, fully integrated, on-site laboratories (clinical pathology, necropsy, tissue trimming, and histology) with a wide range of pathology services to support your needs
  • Accessible, highly qualified pathology professionals who can respond to changing needs quickly and efficiently
  • Robust multi-species historical control database for anatomic and clinical pathology endpoints
  • Integrated Provantis™ system platform for rapid, accurate data capture, entry, and reporting
  • Aperio ScanScope® scanner and Spectrum™ Digital Pathology System for whole-slide scanning and histomorphometry analysis
  • Secure chain-of-custody management and verification of all specimens
A high-quality anatomic pathology evaluation and report are some of the most critical components in the assessment of your compound, device, or combination product. The MPI Research pathology team includes one of the world’s largest collections of experienced, board-certified toxicologic pathologists working within a single site preclinical CRO. Our expert anatomic pathologists understand the significance of their roles and have extensive knowledge on a wide variety of compounds, animal models, and study designs—offering you peace of mind that the evaluation of your compound is in the right hands. As part of our commitment to high-quality pathology data for our Sponsors, we have been long-time advocates of pathology peer review. Pathologists with substantial broad-based pharma experience are available for internal and external peer review or specialized consultation.  Expertise in reproductive pathology, primate pathology, neuropathology, and otic pathology are available.
  • On-site necropsy supervision by a veterinary pathologist
  • High-capacity, multi-species gross pathology facility with dedicated individual small animal and large animal workstations
  • Routine and specialized procedures, including
  • Whole-body and upper body perfusions
  • Perilymphatic perfusions of inner ear for ototoxicity studies
  • Harvesting and processing of vascular and coronary stents
  • Specialized digital imaging equipment
  • High-throughput capacity (capabilities to process over two million tissues annually)
  • Paraffin and frozen tissue processing and slide preparation for routine, specialized, and diagnostic microscopic examination
  • Immunofluorescence and immunohistochemical techniques (over 85 validated)
  • Special staining procedures (over 65 validated)
MPI Research offers a complete array of traditional clinical pathology endpoints and state-of-the-art biomarker capabilities to support a wide range of investigational studies. GLP-compliant validation and quality control measures ensure that data of the highest quality are generated and accurately reported. A team of experienced board-certified clinical pathologists provide expert review and interpretation of data and work with anatomic pathologists to provide an integrated assessment of study finding.

  • Hematology
  • Clinical chemistry
  • Coagulation/platelet characterization
  • Urinalysis
  • Immunoassays/biomarkers
  • Fluid analysis
  • Blood gas analysis
  • Bone marrow evaluation
  • Cytopathology