BBCR specializes in the strategy and delivery of early-phase clinical development services to enable informed, timely decision making for our clients. 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 site of action Investigate […]
Boston Biotech Clinical Research (BBCR) works with biotech, pharmaceutical, and device companies to develop a clinical/regulatory roadmap consisting of simplified clinical programs, streamlined protocols, and cost-effective trials. Our Boston-based, integrated, boutique consulting team specializes in rare disease and orphan indications, and is dedicated to supporting pharmaceutical innovators and nurturing each product’s strengths.
We help to Identify areas of need or economic interest that can help companies find homes for treatments for rare diseases and precision medicine. Developing drugs for rare diseases and precision medicine indications can be rewarding, but navigating the challenges is not for the faint of heart. Expert guidance is essential in an area where […]
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
Strategic Clinical Innovation Organization (SCIO) – A Clear Path to Approval 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 for time and cost efficiencies, and risk mitigation. The BBCR team is armed with extensive clinical, regulatory […]
Neurodegenerative diseases, such as Alzheimer’s disease, Parkinson’s disease, amyotrophic lateral sclerosis, and others, cause neuronal degradation, resulting in progressive brain function deterioration. Although our understanding of neurodegenerative disease mechanisms is still in its relative infancy, scientists pursue understanding of neurodegenerative disease pathogenesis and development that paves identification of new potential therapeutic and treatment approaches. Neurodegenerative […]
FDA guidance (March 2020 and updated July 2020) acknowledged that the impact of COVID-19 may require companies conducting clinical trials to consider virtual patient visits or put new processes in place regarding their current protocols. Since COVID 19 has changed many of our normal way to conduct Clinical research, most organizations reported some level of […]
The publication suggesting a link between COVID-19 and Magnetism has been retracted. The study, published in a peer-reviewed journal, has attracted widespread derision from researchers. The study titled “Can Traditional Chinese Medicine provide insights into controlling the COVID-19 pandemic: Serpentinization-induced lithospheric long-wavelength magnetic anomalies in Proterozoic bedrocks in a weakened geomagnetic field mediate the aberrant […]
Early Phase III data from Pfizer and BioNTech BNT162b2 is the experimental mRNA-based vaccine candidate from Pfizer and BioNTech’s in Phase III study. Since June, 43,538 participants have been enrolled to date, 38,955 of whom have received a second dose of the vaccine candidate as of November 8. On Monday, November 9th, the company announced […]
Observational data suggest that SARS-CoV-2 spreads between people at short distances. SARS-CoV-2 may spread by the primary method of transmission of the SARS-CoV-2 virus—via relatively large respiratory droplets, which fall quickly to the floor under their own weight, or even via the smaller aerosolized droplets capable of circulating in the air for long periods of […]