We aim to transform the transition stage between pre-clinical and clinical endpoints with smart strategy that, at a minimum, redirects the costs to benefit patients. The FDA has been calling for a smarter, more innovative approach, and we believe SCIO is the integrative, multidisciplinary approach to deliver it. Why SCIO? Investing in Strategy Accelerate Patient […]
Streamlined Clinical Development Strategies 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. Specializing in rare disease, Boston Biotech Clinical Research works with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process. […]
The FDA recognizes biomarker development as a high priority area for future research. BBCR can help your company with your product development plan and validation.
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.
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 […]
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 […]
Currently, there are two approved drugs to treat ALS: Riluzole, which can extend lifespan by an average of a few months and has been on the market for 25 years Edaravone, approved in 2017, which in clinical trials showed to help patients function for longer into their disease. Unfortunately, ALS is still a deadly disease […]
Pfizer, a pharmaceutical company, in partnership with BioNTech has reported that its lead vaccine candidates has shown promising results in protecting monkeys against coronavirus infections. Pfizer ‘s experimental vaccine is different from other vaccine candidates. This is in an mRNA format, which should allow for a better migration of the viral gene into the cell […]
Techniques that bypass or trick the guardian of the central nervous system. Developing drugs that can penetrate into the brain requires some creativity. The approaches vary, each technique comes with its benefits and drawbacks, making it appropriate for some patients or drug types but not others. In some diseases, you might want the drug everywhere; […]