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Preclinical

Establishing a Strong Foundation for Safety and Success

Preclinical studies—including bench testing and animal models—are essential for establishing a product’s initial safety profile and form the foundation of any successful clinical trial application. At Insight Medical, our team of technical experts will partner with you to design a preclinical strategy that is efficient, compliant, and cost-effective. We focus on minimizing risk while maximizing the potential for your product’s success.

Our Preclinical Expertise Includes:

  • Preclinical & GLP Animal Study Design
    We design robust preclinical studies, including Good Laboratory Practice (GLP)-compliant animal studies, to help establish safety and efficacy early in product development.
  • Verification & Validation (V&V)
    We assist with V&V processes, verifying that your product meets design specifications and quality standards to minimize risk. Our expertise in engineering, toxicology, biocompatibility, usability, and human factors enables the development of a seamless and effective plan.
  • Interpretation of Preclinical Test Results
    We design robust preclinical studies, including Good Laboratory Practice (GLP)-compliant animal studies, to help establish safety and efficacy early in product development.
  • Guidance on Regulatory Feedback
    We offer expert guidance on how to address regulatory feedback, particularly related to biocompatibility testing, ensuring your preclinical studies are compliant and ready for the next phase.

Ready to Plan Your Preclinical Studies?

Let Insight Medical help you establish a strong foundation for your clinical trial application.

Contact us today to learn more about our pre-clinical services and how we can support your product’s development.

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Boston, MA
info@iMEDus.com

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