Did you know that about a third of orphan approvals by the FDA since the program began have been mostly for repurposed mass-market drugs?
Drug repurposing acts to lower the need for early stage clinical trials and can help identify new uses for existing drugs. We invite you to learn more about how BBCR can help.
Our services include:
- Candidate assessment for 505(b)(2) approval pathway
- FDA meeting and submission
- Pre-IND integrated development plan
- Clinical study design and protocol
- CRO and project management
- Project remediation and rescue
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.