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 […]
Specializing in rare disease, Boston Biotech Clinical Research works with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process. We understand that navigating the rare disease development process requires expert guidance. BBCR can assist in the following areas: Biologics Biosimilars Small Molecules Medical Devices Drug Repurposing Why the SCIO? Clinical trials are […]
BBCR provides expert market guidance and embraces innovative strategy consulting for effective clinical development plan and regulatory strategy. Developing drugs for rare diseases and precision medicine indications can be rewarding, but navigating the challenges is not for the faint of heart. Expert guidance is essential in an area where the patients are few, lack of […]
We aim to transform the transition stage between pre-clinical and clinical endpoints with smart strategy that, at a minimum, redirects the costs to benefit patients. The FDA has been calling for a smarter, more innovative approach, and we believe SCIO is the integrative, multidisciplinary approach to deliver it. Why SCIO? Investing in Strategy Accelerate Patient […]
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 medicine combined with SCIO approach helps streamline trials for swift regulatory approvals. Real-World Data can be collected and approved by regulators for Evidence Generation Regarding Safety and Effectiveness. […]
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 […]