Biomarkers are considered a routine part of drug development. Learn more about how BBCR can help get your product to market more efficiently with proper plan development and strategy. Plan Development Insightful strategy is the most effective way to ensure quality when including biomarkers into your product development plan. Validation or Qualification Understanding where […]
Moderna announced on January 25 plans for testing two different booster vaccines aimed at the SARS-CoV-2 variant B.1.351 that emerged in South Africa and has now spread to numerous countries. Moderna COVID-19 Vaccine produced neutralizing titers against all key emerging variants tested, including B.1.1.7 and B.1.351, first identified in the UK and Republic of South […]
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 […]
Boston Biotech Clinical Research (BBCR) works with biotech, pharmaceutical, and device companies to develop a clinical/regulatory roadmap consisting of simplified clinical programs, streamlined protocols, and cost-effective trials. Our Boston-based, integrated, boutique consulting team specializes in rare disease and orphan indications, and is dedicated to supporting pharmaceutical innovators and nurturing each product’s strengths.
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 […]
BBCR’s team has experience in biologics for rare diseases including rare cancers and precision medicine and can help develop a targeted strategy including studies with fewer patients to control safety issues. Services include: Indications analysis and prioritization Strategic drug assessment Clinical study design and protocol Biomarker strategy Early Clinical Development FDA meeting and submission Pre-ND […]
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 and industry experience that we use […]
Our industry is looking for an innovative process. 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. BBCR specializes in the strategy and delivery of […]
