Real World Evidence
Understanding how a Strategic Clinical Innovation Organization can help streamline the clinical trial process.
October 13th, 2021 | Real World EvidenceBBCR offers streamlined clinical development and clinical and regulatory expertise to a variety of clients both domestically and internationally.
October 6th, 2021 | Real World Evidence
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 | Real World Evidence
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 […]
Our CRO Management services reduce trial costs while achieving high data quality. 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.
September 28th, 2021 | Real World Evidence
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 […]
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 | Real World Evidence
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.
BBCR 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 | Real World Evidence
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 […]
Small molecule mediated targeting provides alternative strategies for polypharmacology, systems biology and personalized medicine.
September 7th, 2021 | Real World Evidence
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 […]
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 | Real World Evidence
BBCR 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 | Real World Evidence
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 | Real World Evidence
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 […]