At BBCR, our team of seasoned experts is dedicated to helping clients navigate the intricate landscape of rare genetic conditions and unsolved diseases. We work hand in hand with product developers to create the most effective strategies for bringing innovative treatments to market.

We invite you to discover how BBCR can be your trusted partner in this journey. Our comprehensive services include:

  • Candidate assessment for the 505(b)(2) approval pathway, ensuring a streamlined process
  • FDA meeting and submission to facilitate clear communication with regulatory bodies
  • Pre-IND integrated development plans that set the foundation for success
  • Clinical study design and protocol tailored to meet specific research needs
  • CRO and project management that guarantees efficiency and quality
  • Project remediation and rescue strategies to get projects back on track

At BBCR, we believe in the transformative power of collaboration and innovation. Our dedicated team is committed to addressing the unique challenges posed by rare diseases, ensuring that every client receives personalized attention and customized solutions. Together, we can turn obstacles into opportunities and pave the way for groundbreaking advancements in healthcare.


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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.