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Our industry needs innovative strategies, and reduced-risk clinical trials. BBCR clinical development services and drug development consulting integrates real world evidence into clinical development plans and regulatory strategies.
Focus must go to cost containment and value-based developments that allow sponsors to move more treatments to market faster. BBCR’s team expertise in rare diseases and precision medicine combined with SCIO approach helps streamline trials for swift regulatory approvals.
A sound research design and consistent procedures minimize risks to subjects. When considering risk in clinical trials, our attention should focus on the complexity of study design/study characteristics and patient characteristics. In addition, the study drug safety data and pharmacological class are vital components of our risk analysis.
Both the FDA and EMA put the sponsors under constant pressure to ensure that clinical trial data is credible and accurate. The risk of flawed data set at-risk patient safety and clinical trial data credibility. Poor data are ultimately leading to the rejection of the drug during a marketing application.
Specializing in rare disease, Boston Biotech Clinical Research works with biotech, pharmaceutical, device companies and investors to streamline the clinical trial process. 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.