We are dedicated to addressing the complex challenges faced by sponsors and investors who seek a clear and streamlined path to market. Our approach focuses on nurturing the inherent strengths of their products while simultaneously enhancing efficiency, safety, and regulatory compliance. With deep expertise in strategic planning, we specialize in providing comprehensive early clinical research […]
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 […]
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 […]
BBCR is committed to meeting the challenges of sponsors and investors seeking a clear path to market by nurturing their products’ strengths while improving efficiency and safety. We specialize in strategy and provide early clinical research services to enable informed, timely decision-making for our clients. Learn more about the services we provide within the areas […]
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 […]
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 […]
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 […]
An early-phase strategy improves productivity and the path to market approval. SCIO SM Advantages Accelerate Patient Recruitment Reduce Patient Number Reduce Clinical Development Time Reduce Trial Monitoring Time Increase Patient Retention Facilitate Decision Making Increase Data Quality The FDA has been calling for a smarter, more innovative process for market approval, and SCIO SM is […]
Speaking Topic: Increasing Investor’s Evaluation of SME Biotech in a Slumping Market BBCR will be speaking on the challenges investors face and how to successfully navigate today’s Biotech market.