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CBSET GLP Preclinical Services

CBSET is a multidisciplinary, translational research institute, providing preclinical services that support a range of applications in therapeutic and device development, with OLAW-assured, AAALAC-accredited animal research facilities and GLP-compliant analyses.

CBSET Study Design Guide

An overview of the principal features relating to the design and conduct of nonclinical studies. CBSET scientists, veterinarians, pathologists, and other staff will review these features in greater detail to formulate a study design specific to your technology/therapy.

Cell-Based Therapies

Cell-based medicines are being developed for every therapeutic area, each a novel regulatory challenge. CBSET is a translational research institute that specializes in the advancement of novel therapies.

GLP Preclinical Services for Auditory Safety

CBSET, a state-of-the-art GLP-compliant translational research institute, and Cilcare, a leading biotech specializing in auditory science, have partnered to offer cutting-edge preclinical services and regulatory support for the assessment of your products for auditory indications.

Cardiovascular Research

CBSET was founded by renowned experts in cardiovascular research, with expertise in performing GLP-compliant preclinical procedures.

Localized / Targeted Drug Delivery

Targeted drug delivery localizes exposure to the site of action, overcoming physiological barriers. Novel excipients and modes of administration have synergized with biocompatible materials and biological agents to optimize bioavailability and open new therapeutic strategies.

GLP Histopathology and Morphometry

Histology is a critical endpoint for the evaluation of medical devices, drugs, biologics and biomaterials. CBSET's histopathology facility and ACVP-boarded pathologists provide flexible support and active collaboration for all facets of sample processing, staining, imaging and analysis, pairing it with expert interpretation and reporting.

State-of-the-Art Swine Breeding Facility

CBSET’s AAALAC-accredited swine breeding facility, a newly refurbished 22,000 ft² facility located in Grafton, MA, provides purpose-bred swine for research.

Computed Tomography (CT) Imaging

Clinical CT imaging systems can provide a valuable complement for your preclinical research and development. CBSET employs an 8-slice small-bore portable Samsung CereTom® CT scanner that delivers the highest quality noncontrast, angiography, and contrast perfusion scans in a variety of locations.

Evaluation of Mesh Implants and Related Devices

Prosthetic patches, meshes or plugs made from synthetic or biologically-derived materials are often used in the repair procedure for surgical or laparoscopic approaches in a variety of locations, including breast reconstruction, abdominal/pelvichernia repair, and hiatal hernia repair.

Biomechanical Testing

Mechanical testing of both biomaterials and biological tissues can be a critical component in both the design and evaluation of medical devices.

Scanning Electron Microscopy

High-resolution imaging can be a powerful tool in supporting product development and technology differentiation, and in fortifying regulatory submissions. CBSET offers Scanning Electron Microscopy (SEM) services that complement our other services, including in-life studies, pathology service and mechanical testing.