Strategy and TPP

SCIO

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 | Strategy and TPP

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 | Strategy and TPP

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 […]

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 | Strategy and TPP

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 […]

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 | Strategy and TPP

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 offers innovative approaches to de-risk your product development during Early Clinical Development

April 2nd, 2021 | Strategy and TPP

Depending on your project goals, our consultants work with you to design cost-effective early clinical studies that hold potential for reducing Phase III failures. Our services include: POM & POC Translational Research Clinical Plan & Study Design Phase 1 & 2 Protocol Development Medical Monitors Study Management  

Specializing in rare disease, Boston Biotech Clinical Research works with biotech, pharmaceutical, device companies and investors to help streamline the clinical trial process.

March 11th, 2021 | Strategy and TPP

Our experienced team helps each client reach their specific goals by customizing a clinical and regulatory road map of simplified programs and streamlined protocols to meet our clients’ requirements. BBCR Consulting offers world-class regulatory, clinical research, and biomarker consulting services that provide high-value, and support our clients’ operational and functional needs. Our process is designed […]

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 | Strategy and TPP

Expertise 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 […]

In rare diseases and precision medicine, implementation of biomarkers during product translation into clinic and early clinical development moves treatment to market faster. BBCR is experienced in helping you understand the role of biomarkers and how to move your product to market more efficiently.

February 24th, 2021 | Strategy and TPP

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 […]

Identification and adoption of biomarkers are especially valuable in rare disease and precision medicine product development. Learn more about how BBCR can help.

February 9th, 2021 | Strategy and TPP

Biomarkers are now a routine part of drug development The FDA recognizes biomarker development as a high priority area for future research. The FDA and European Medicines Agency (EMA) have developed similar processes for the qualification of biomarkers intended for use as companion diagnostics or for development and regulatory approval of a drug or therapeutic. […]

BBCR can help with your Pre-ind Integrated Development Plan

December 14th, 2020 | Strategy and TPP

A strategy that clearly marks the path to success creates opportunity to reduce risk. BBCR works with clients to achieve a successful pre-IND meeting by: Reviewing scientific data Setting regulatory strategy Setting integrated plan Creating messages and outlines Developing realistic Q&As Providing constructive critique    

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