Real World Evidence

BBCR Company News

Mutants: the challenges of COVID 19 Vaccine

April 13th, 2021 | Real World Evidence

True or false: Virus variants weaken the effectiveness of COVID 19 Vaccine Coronavirus vaccines have significantly reduced the infectiousness of COVID 19 cases and showed significant protective efficacy against COVID 19. However, the recent reported COVID19 variants B.1.1.7 in the UK and B.1.351 in South Africa are of concern because of their more accessible and […]

Cell and gene advanced therapy in the Battle for Lysosomal Storage Disease

April 8th, 2021 | Real World Evidence

Emerging cell and gene therapy may offer sustained long-term correction for LSD patients Dr. Maria Niu Lysosomal storage diseases (LSDs) are rare inherited metabolic diseases and characterized by the accumulation of substrates in excess in various organs’ cells due to lysosomes’ defective functioning. The combined incidence of LSDs is between 1 in 5000 to 1 […]

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

April 2nd, 2021 | Real World Evidence

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  

BBCR has experience in biologics for rare diseases and can assist with the development of a targeted strategy to meet your study needs.

March 24th, 2021 | Real World Evidence

Biologic treatments show promise in providing clinical solutions to a variety of diseases including rare cancers and precision medicine. Services include: Indications analysis and prioritization Strategic drug assessment Clinical study design and protocol Biomarker strategy Early Clinical Development FDA meeting and submission Pre-ND integrated development plan CRO and project management Study remediation and rescue   […]

Our Strategic Clinical Innovation Organization or SCIO method enables our clients to save time, create cost efficiencies, and reduce risk on the path to achieving optimal product market positioning. Reach out to BBCR today to learn more.

March 17th, 2021 | Real World Evidence

Our Strategic Clinical Innovation Organization (“SCIO”) method enables our clients to save time, create cost efficiencies, and reduce risk on the path to achieving optimal product market positioning. 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 allows […]

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 | Real World Evidence

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 | Real World Evidence

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 | Real World Evidence

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 […]

Covid-19 vaccine reduces infectiousness—a key factor in slowing virus spread.

February 17th, 2021 | Real World Evidence

Preliminary results from an Israel-based study suggest that one dose of the Pfizer’s vaccine reduces viral load- a key factor in slowing virus spread. Several of the approved to market COVID-19 vaccines are over 90% effective in preventing disease. But no much data have been available about whether vaccinated individuals can still transmit the SARS-CoV-2 […]

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 | Real World Evidence

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. […]