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In the fields of orphan diseases and precision medicine, establishing a robust biomarker strategy during translational and early clinical development is key to expediting time-to-market.
A well-defined biomarker plan not only streamlines regulatory approval but also aligns with FDA expectations for safety and efficacy. Discover how our expertise in biomarkers and surrogate endpoints can help you develop an efficient, compliant path to market success.
Interest is increasing rapidly in using surrogate endpoints as primary measures of the effectiveness of investigational drugs in definitive drug trials. The primary difference between a biomarker and a surrogate endpoint is that a biomarker is a “candidate” surrogate marker. In contrast, a surrogate marker is a test used and taken to measure the effects of a specific treatment. Click the button below to learn more about how BBCR can assist with your plan development needs.
Specializing in rare disease, Boston Biotech Clinical Research works with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process. Our experienced team helps each client reach their specific goals by customizing a clinical and regulatory road map of simplified programs and streamlined protocols to meet our clients’ requirements.