A strategy that clearly marks the path to success creates opportunity to reduce risk. BBCR works with clients to achieve a successful pre-IND meeting by: Reviewing scientific data Setting regulatory strategy Setting integrated plan Creating messages and outlines Developing realistic Q&As Providing constructive critique
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 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. BBCR Consulting has created a process called SCIO (Strategic Clinical Innovation Organization), designed to change the path from pre-clinical trial to market by creating a regulatory […]
BBCR Consulting offers world-class regulatory, clinical research, and biomarker consulting services that provide high-value, and support our clients’ operational and functional needs. Our process is designed to maximize time efficiencies, risk mitigation, and cost savings. Innovating the process of drug development with clinical and regulatory expertise is the central value of our business. BBCR’s mission […]
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 […]
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. BBCR Consulting offers world-class regulatory, clinical research, and biomarker consulting services that provide high-value, and support our clients’ operational and functional needs. Our process is designed […]
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 […]
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. BBCR’s medical experts optimize development strategies for biotech companies, venture capitalists, investors, research organizations and pharmaceutical companies. At BBCR Consulting, our team specializes in rare disease […]
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 […]
Pediatric Rare diseases and Rare Pediatric Disease Designation FDA will award priority review vouchers to sponsors of certain rare pediatric disease product applications that meet the criteria specified. Section 529 of the FD&C Act is intended to encourage development of new drug and biological products for the prevention and treatment of rare pediatric diseases. Section […]