Medical Affairs and Clinical Research
BBCR offers expertise in the areas of Product Development Planning and Validation or Qualification when biomarkers are a part of your product development plan.
October 26th, 2021 | Medical Affairs and Clinical ResearchBoston Biotech Clinical Research specializes in rare disease, working with biotech, pharmaceutical, device companies and investors to help streamline the clinical trial process.
October 20th, 2021 | Medical Affairs and Clinical Research
Understanding how a Strategic Clinical Innovation Organization can help streamline the clinical trial process.
October 13th, 2021 | Medical Affairs and Clinical Research
BBCR offers streamlined clinical development and clinical and regulatory expertise to a variety of clients both domestically and internationally.
October 6th, 2021 | Medical Affairs and Clinical Research
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 […]
Document preparation and submissions is critical to the success of bringing your product to market. Rely on the BBCR team to know what to submit and when for the most efficient process.
September 30th, 2021 | Medical Affairs and Clinical Research
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 […]
With Biomarkers now a routine part of drug development, BBCR assists companies with the identification and adoption of biomarkers, especially valuable in rare disease and precision medicine product development.
September 22nd, 2021 | Medical Affairs and Clinical Research
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.
Small molecule mediated targeting provides alternative strategies for polypharmacology, systems biology and personalized medicine.
September 7th, 2021 | Medical Affairs and Clinical Research
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 […]
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 | Medical Affairs and Clinical Research
BBCR 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 | Medical Affairs and Clinical Research
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 […]
BBCR can help you better understand the role Real World Evidence (RWE) plays for natural history in rare diseases
July 13th, 2021 | Medical Affairs and Clinical Research
Knowledge 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 […]