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Biomarkers are now a routine part of drug development
The FDA recognizes biomarker development as a high priority area for future research. The FDA and European Medicines Agency (EMA) have developed similar processes for the qualification of biomarkers intended for use as companion diagnostics or for development and regulatory approval of a drug or therapeutic.
In rare diseases and precision medicine, implementation of biomarkers during product translation into clinic and early clinical development, moves treatment to market faster.
Our ares of expertise include:
Product Development Planning
Insightful strategy is the most effective way to ensure quality when including biomarkers into your product development plan.
Validation or Qualification
Understanding where to go if biomarker validation takes your study in a different direction can create valuable efficiencies in bringing a product to market.
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.