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Real World Evidence
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 EvidenceBBCR 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 […]
BBCR can help you better understand the role Real World Evidence (RWE) plays for natural history in rare diseases
July 13th, 2021 | Real World Evidence
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 […]
Identification and adoption of biomarkers are especially valuable in rare disease and precision medicine product development. BBCR can assist in developing your biomarker plan and validation process.
July 8th, 2021 | Real World Evidence
Biomarkers are now a routine part of drug development In rare diseases and precision medicine, implementation of biomarkers during product translation into clinic and early clinical development, moves treatment to market faster.
The BBCR team of experts works with clients to build a customized strategy in the areas of pre-clinical and clinical product development and regulatory affairs.
June 29th, 2021 | Real World Evidence
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, small and medium sized drug and device biotechnology firms as well as venture capitalist. Clinical researchers and innovators come to us looking for the […]
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 | Real World Evidence
Given 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 […]
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 ensures time and cost efficiencies, and risk mitigation.
June 10th, 2021 | Real World Evidence
BBCR has developed an approach to meet the challenges of researchers and innovators seeking a clearer path to market. Flexible Road-Map Successful clinical development, for drug and medical device companies (small and large), requires an early strategy with a flexible road-map that makes it actionable and sustainable. Robust Clinical Data Customized Strategy and Road-Map allow […]
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 | Real World Evidence
Drug 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 | Real World Evidence
The 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 […]