Tags: Developing innovative or repurposing drugs for orphan diseases can be rewarding, but navigating the challenges is not for the faint of heart.
Expert guidance is essential in an area where patients are few; a lack of previous studies may hamper progress as you mount an orphan petition and negotiate a clinical plan with the FDA.
Our regulatory and clinical research consultants are experts in biologics, cell and gene therapies, and small molecule developments. Identifying areas of need or economic interest can help sponsors find homes for treatments for orphan indications.
BBCR consultants have the experience to guide you through the Orphan clinical research process with a clinical plan and regulatory strategy for an accelerated approval. Our team will empower you with medical insight, practical regulatory, translational medicine, and clinical research expertise, and streamlined clinical trials.
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.