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 […]
The BBCR team of experts has worked in pre-clinical and clinical product development and regulatory affairs. We believe that understanding the perspective, challenges, and needs of our clients allows us to serve as a trusted adviser throughout the clinical development process. BBCR clients are domestic and international drug and device biotechnology firms as well as […]
Documentation of clinical processes and preparing the essential paperwork for timely submission can open doors to expediting the approval process. Boston Biotech Clinical Research can provide: Strategy and guidance for FDA meeting requests, briefing packages, preparation and attendance Author, review and publish original applications, amendments and supplements Prepare or assist in the preparation of regulatory […]
BBCR takes a SCIO approach to CRO management that efficiently communicates back to senior management meeting the needs of the new economy and the needs of patients and shareholders. BBCR focuses on providing biotech and pharmaceutical companies with an assortment of services tailored to support clinical development programs transitioning from pre-clinical into Phase II PoC […]
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.
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 […]
Most ongoing research and clinical programs have precision medicine at the core. BBCR can assist in a number of areas in relation to precision medicine, including small molecule research, including: Strategic drug assessment Early Clinical Development Regulatory consultant FDA meeting and submission Pre-IND integrated development plan Clinical consultant Clinical study design and protocol CRO and […]