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 high quality data. Rare Diseases and Precision Medicine Require Unique Approaches In Clinical Trial Design. There could be any number of factors that could necessitate a study being rescued. […]
Dr. Fratazzi’s contributions have been significant. 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 […]
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 […]
We invite you to read some of our Case Studies below Reduced Comparator High Cost for Biosimilars PROJECT An executive at a pharmaceutical company asked BBCR to review its biosimilar pre-clinical data and prepare the IND package. In addition to evaluate the innovator approved indications to identify the fastest and less risky trial to NDA […]
BBCR specializes in the strategy and delivery of early-phase clinical development services to enable informed, timely decision making for our clients. Proof of Mechanism (PoM) Usually in Healthy Volunteers, Phase 1 study Essential for the selection of appropriate dose for PoC, disease model and biomarkers Investigate drug concentration at the target site of action Investigate […]
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. Our consultants have the experience to guide you through the Orphan clinical research process with a clinical plan and regulatory strategy for accelerated approval. Our team will […]
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 […]
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 […]