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Insight Medical Consulting

Making Concepts a Reality for Patients 

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Medical Professional

THE VISION

Services

At Insight Medical, we believe in partnering with our innovative thinking clients to optimize the path to secure product marketing approval.  And with a commercially available product, we can guide you through to the next level of maintaining compliance with regulatory statutes and assisting with next generation product concepts. 

Strategic Consulting

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  • Develop clinical/regulatory strategy to optimize process

  • Clinical trial design to "fit" with regulatory pathway

  • Clinical Study Report Generation

PreClinical Studies

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  • Benchtop Study Plans

  • Animal Study Plans

  • Interpretation of test results

  • Guidance on addressing regulatory questions on testing

Due Diligence

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  • Evaluate business opportunities from Reg/Clin perspective.

  • Ensure unmet clinical need aligns with program and product value

Making Sense of Clinical Trial Results

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  • Interpret clinical trial results 

  • Develop key messaging 

  • Risk/Benefit analyses

International Strategic Consulting

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  • Clinical and Regulatory Strategies

  • World-wide clinical trial design

  • PMCF program design

Regulatory Submissions

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  • PreIND

  • PreIDE

  • IDE

  • IND

  • 510(k) - De Novo 510(k)

  • PMA

  • BLA

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