Our industry needs innovative strategies, and reduced-risk clinical trials. BBCR clinical development services and drug development consulting integrates real world evidence into clinical development plans and regulatory strategies. We ensure that focus goes towards cost containment and value-based developments that allow sponsors to move more treatments to market faster. BBCR’s team expertise in rare diseases […]
Her journey began when she founded BBCR Consulting, an organization dedicated to strategic clinical innovation, aiming to streamline the often convoluted processes of clinical trials. Drawing from her extensive 25 years in biomedical research, Dr. Fratazzi introduced the SCIOTM concept, a revolutionary approach aimed at creating efficiencies in the intricate journey of bringing biotech products […]
Our selected services include expertise with Biomarkers & Surrogate Endpoints, Regulatory Affairs FDA & EMA, Medical Affairs & Clinical Research, Due Diligence, and Trial Management & Trial Rescue. BBCR’s Strategic Clinical Innovation OrganizationSM (SCIO) method is explicitly designed to help pharmaceutical innovators address their concerns and maneuver around evolving challenges. SCIOSM identifies time and cost […]
Providing Expert Guidance for Orphan Drug Development BBCR is dedicated to supporting pharmaceutical innovators in the specialized rare diseases and orphan drug indications by developing and nurturing the product’s unique strengths. Our operational mission is to craft customized strategies that achieve cost-effective trials by 1) simplifying clinical plans, 2) streamlining trial protocols and 3) creating […]
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. Click the button below to learn more about how we have helped companies with their clinical trial needs.
The Strategic Clinical Innovation Organization SCIO SM (SCIO) method is explicitly designed to help pharmaceutical innovators address their concerns and maneuver around evolving challenges. SCIO SM allows for time and cost efficiencies and relief of risk management. The SCIO SM method aims to learn, predict and make better decisions for a successful drug opportunity. This […]
How can SCIO help? To enhance your position, it becomes crucial to demonstrate that your product/technology is the “safe” option for investment and a stand-out opportunity by including a clinical roadmap and development strategy of your product/technology. This roadmap illuminates clearly for the investment team what the target indications will be and the paths to […]
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 […]