Over the past forty years, the drug development process has changed significantly. In the last twenty years, the industry has invested in gathering scientific data to inform clinical questions. Since 2000, the clinical research’s primary objective has been to marry feasibility and great science to generate anticipatory and adaptive data. Ultimately, to support go-no/go decisions […]
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 […]
Our proprietary Strategic Clinical Innovation Organization (SCIO) concept was developed to address and maneuver around evolving challenges, allowing for time and cost efficiencies, and mitigating risk. BBCR works with clients in the areas of Biomarkers, Clinical Research consulting, Regulatory Affairs, and Early Clinical Development. To learn more about how BBCR can help with your research […]
Our Strategic Clinical Innovation Organization (“SCIO”) method enables our clients to save time, create cost efficiencies, and reduce risk on the path to achieving optimal product market positioning. The Strategic Clinical Innovation Organization (SCIO) concept developed by BBCR was designed specifically to help pharmaceutical innovators address the concerns and maneuver around evolving challenges. SCIO allows […]
Strategic Clinical Innovation Organization (SCIO) – A Clear Path to Approval The Strategic Clinical Innovation Organization (SCIO) concept developed by BBCR was designed specifically to help pharmaceutical innovators address the concerns and maneuver around evolving challenges. SCIO allows for time and cost efficiencies, and risk mitigation. The BBCR team is armed with extensive clinical, regulatory […]
A Priority Review designation does not alter the scientific/medical standard for approval or the quality of evidence necessary and it does not affect the length of the clinical trial period. Prior to approval, each drug marketed in the United States must go through a detailed FDA review process. FDA drug review time includes two-tiered system […]
