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 […]
Tagged: Boston Biotech Clinical Research
BBCR offers streamlined clinical development and clinical and regulatory expertise to a variety of clients both domestically and internationally.
October 6th, 2021 | Boston Biotech Clinical ResearchBBCR embraces innovative strategy consulting for effective clinical development plan and regulatory strategy. Reach out today to learn more about how we can help advance your project.
September 15th, 2021 | Boston Biotech Clinical ResearchOur 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 […]
The most efficient path in the clinical research process is a moving target. Biotech innovation and regulatory requirements require constant monitoring. Through BBCR Voice, we aim to share not only our knowledge and expertise, but also solutions to current challenges in the regulatory and research environments.
August 5th, 2021 | Boston Biotech Clinical ResearchBBCR is dedicated to meeting the challenges of developers and investors seeking a clearer path to market. We invite you to bookmark our blog page and follow us across social media to keep abreast of timely and relevant topics in our industry.
BBCR meets clients’ needs in the ever-changing regulatory environment. As specialists in Orphan and Personalized Medicine, BBCR helps clients identify areas of need or economic interest and helps them find homes for treatments for rare diseases and precision medicine.
August 2nd, 2021 | Boston Biotech Clinical ResearchBBCR helps orphan drug developers find direction in clinical trials involving biologics, biosimilars, small molecules, medical devices, and repurposing. BBCR consultants have the experience to guide you through the development process with a clinical plan and a regulatory strategy. Our team will empower you with medical insight, effective regulatory expertise, strategy, and streamlined early clinical […]
Boston Biotech Clinical Research specializes in rare disease and works with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process.
July 20th, 2021 | Boston Biotech Clinical ResearchOur 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 […]
BBCR can help you better understand the role Real World Evidence (RWE) plays for natural history in rare diseases
July 13th, 2021 | Boston Biotech Clinical ResearchKnowledge of disease and its Natural History is an essential element of any clinical development program. Real-World Data (RWD) is data relating to patient health status and/or the delivery of healthcare routinely collected from a variety of sources. Under the right conditions, data derived from real world sources can be used to build Rare diseases […]
Has Covid-19 hampered your clinical research projects? Let BBCR help jump start your product development initiative in order to achieve optimal product market positioning
June 16th, 2021 | Boston Biotech Clinical ResearchGiven the global Covid19 pandemic and the global nature of the pharmaceutical and biotech industry, key operational areas have and will continue to be impacted. As with any emergency response, the key to management is implementing mitigation plans. Early stage pharmaceutical and biotech companies need to be proactive in developing contingency plans to jump start […]
BBCR’s team of industry experts help our clients match treatments to rare genetic conditions and unsolved diseases, then work with a product developer on the best plan to market.
June 8th, 2021 | Boston Biotech Clinical ResearchDrug repurposing acts to lower the need for early stage clinical trials and can help identify new uses for existing drugs. People tend to believe that a repurposed therapy can never be truly novel or transformative. Nothing could be further from the truth. One attractive option of Drug Repurposing is to use a scientific approach […]
Boston Biotech Clinical Research uses innovative approaches to de-risk your product development. For our clients interested in Proof of Mechanism and Proof of Concept – PoM and PoC – BBCR has the expertise to ensure successful product development at any stage of development.
June 3rd, 2021 | Boston Biotech Clinical ResearchThe BBCR team designs Proof of Concept (PoC) Trials and Proof of Mechanism (PoM) studies with the drug clinical plan and regulatory strategy in mind. 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 […]
Depending on your project goals, BBCR can work with you to design cost-effective early clinical studies that hold potential for reducing Phase III failures.
March 3rd, 2021 | Boston Biotech Clinical ResearchExpertise in integration of in vitro and in vivo analysis during early clinical research is a critical development milestone for efficient candidate development. In addition, the BBCR team guides in identifying the right target, the right biomarker, the right safety, the right patients and the right commercial potential. BBCR can assist clients across a variety […]