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 […]
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 […]
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 […]
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 […]
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 […]
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. […]
Multiple SARS-CoV-2 variants are circulating globally. Several new variants have emerged in the fall of 2020. Many variants are relatively unremarkable. But scientists have been keeping a close watch on three rapidly spreading variants—first identified in the UK, South Africa, and Brazil—which harbor an unusual constellation of mutations. They all share a mutation that affects […]
Moderna announced on January 25 plans for testing two different booster vaccines aimed at the SARS-CoV-2 variant B.1.351 that emerged in South Africa and has now spread to numerous countries. Moderna COVID-19 Vaccine produced neutralizing titers against all key emerging variants tested, including B.1.1.7 and B.1.351, first identified in the UK and Republic of South […]
Scientists report that gut microorganisms in COVID-19 patients were very different from those in uninfected individuals and lack of good bacteria that regulate our immune system. The presence of an abnormal gut bacteria persists after the virus is gone and may be responsible of the long-lasting symptoms in some patients. In addition, reduction of inflammation […]
Type1 diabetes usually develops in children or young adults and requires daily insulin to survive. Scientist report that patients with Type 1 diabetes who become infected with the COVID19 may develop a diabetes complication known as ketoacidosis. A study in 180 patients from across the United States with type 1 diabetes and COVID-19 included 43% […]