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 […]
The BBCR mission is to simplify clinical research, encourage cost-effective trials, and help innovators navigate through the regulatory process. Who We Serve: Small & Medium Sized Biotech Companies currently moving from pre-clinical studies toward clinical trials in need of interim Chief Medical Officer in need of regulartory strategy consultancy in need of preparing a pre-IND meeting […]
The FDA recognizes biomarker development as a high priority area for future research. BBCR can help your company with your product development plan and validation. 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 […]
While an early clinical strategy offers numerous advantages, it also comes with certain challenges that need to be considered: Limited Information: Limited information available about the investigational product can make it challenging. High Risk of Failure: Developing an early clinical strategy without a comprehensive understanding of potential challenges and risks could lead to significant financial […]
Developing an effective early clinical strategy requires collaboration between various experts. The strategy is a living document that can evolve as new data becomes available and as the project progresses through clinical development. Study Design: The design must be robust enough to answer the intended scientific questions. Safety Assessment: It details how safety will be […]
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.
Translational medicine is a bridge between pre-clinical and early clinical development (from bench to bedside), creating the foundation for precision medicine in late clinical development. A translational medicine program includes the adopting biomarkers to mitigate clinical trial risk, identify patient subpopulations, facilitate decision-making, and accelerate a drug’s market approval.
Our goal is to optimize every aspect of the research and development process We will: Improve protocol development, including current trends in clinical trial designs and endpoints Benchmark relevant historical trial enrolment with unmet needs and ongoing trial inclusion criteria Develop a clinical strategy including patient segmentation and biomarkers, streamlining operational costs through more efficient […]
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 […]