BBCR’s mission is to deliver cost-effective clinical plans and regulatory strategies for cell and gene therapy programs in the areas of rare disease. Cell and Gene therapy are the new frontiers in the fight against devastating diseases, including rare diseases and cancers. Clinical trial results have been promising, and the next generation of Cell and […]
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 […]
Designed primarily to meet regulatory requirements for therapies targeting large patient populations, the existing development model lacks flexibility and efficiency to address today’s drug development demands. Challenges include managing product pipelines, targeting small and heterogeneous patient populations, meeting rising standards of evidence from payers moving towards value-based reimbursement models, and addressing the rising role of […]
BBCR specializes in taking the complexity inherent to the regulatory phase of the approvals and simplifying it by strategizing our support to each client based on product-specific regulatory requirements and functional needs. Our expertise spans: Regulatory Strategy FDA Meeting & Submission Pre-IND Integrated Development Plan Regulatory Submissions
Every clinical study has its unique challenges that initially may not have been factored for. Experienced management can help sponsors to address prolonged trial timeline and data quality. Rare Diseases and Precision Medicine require unique approaches to trial execution and data quality. There could be any number of factors that could necessitate a study being […]
BBCR Consulting offers clinical, regulatory, translational, and biomarker consulting services that support our clients’ needs. Our process is designed to maximize time and cost efficiencies while mitigating risk. We partner with domestic and international companies. Our mission is to support pharma and biotech companies, and nurture their products’ strengths while improving efficiency and safety.
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 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 […]
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. Focus must go to cost containment and value-based developments that allow sponsors to move more treatments to market faster. BBCR’s team expertise in rare diseases and precision […]
If you’re interested in learning more about drug repurposing to treat rare disease, BBCR can help with your regulatory consulting needs. We offer expertise in the following areas: FDA meeting and submission Pre-IND integrated development plan Clinical consultant Clinical study design and protocol CRO and project management Study remediation and rescue