Biologic treatments show promise in providing clinical solutions to a variety of diseases including rare cancers and precision medicine. Related Services Include: Indications analysis and prioritization Strategic drug assessment Clinical study design and protocol Biomarker strategy Early Clinical Development FDA meeting and submission Pre-ND integrated development plan CRO and project management Study 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. We understand that navigating the rare disease development process requires expert guidance. BBCR can assist in the following areas: Biologics Biosimilars Small Molecules Medical Devices Drug Repurposing Why the SCIO? Clinical trials are […]
BBCR provides expert market guidance and embraces innovative strategy consulting for effective clinical development plan and regulatory strategy. Developing drugs for rare diseases and precision medicine indications can be rewarding, but navigating the challenges is not for the faint of heart. Expert guidance is essential in an area where the patients are few, lack of […]
Streamlined Clinical Development Strategies 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. Specializing in rare disease, Boston Biotech Clinical Research works with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process. […]
Over the past forty years, the drug development process has changed significantly. In the last twenty years, the industry has invested in gathering scientific data to inform clinical questions. Since 2000, the clinical research’s primary objective has been to marry feasibility and great science to generate anticipatory and adaptive data. Ultimately, to support go-no/go decisions […]
BBCR takes a SCIO approach to CRO management that efficiently communicates back to senior management meeting the needs of the new economy and the needs of patients and shareholders. BBCR focuses on providing biotech and pharmaceutical companies with an assortment of services tailored to support clinical development programs transitioning from pre-clinical into Phase II PoC […]
BBCR helps orphan drug developers find direction in clinical trials involving biologics, biosimilars, small molecules, medical devices, and repurposing. BBCR consultants have the experience to guide you through the development process with a clinical plan and a regulatory strategy. Our team will empower you with medical insight, effective regulatory expertise, strategy, and streamlined early clinical […]
Our proprietary Strategic Clinical Innovation Organization (SCIO) concept was developed to address and maneuver around evolving challenges, allowing for time and cost efficiencies, and mitigating risk. BBCR works with clients in the areas of Biomarkers, Clinical Research consulting, Regulatory Affairs, and Early Clinical Development. To learn more about how BBCR can help with your research […]