RWE can accelerate approval timelines and reduce drug development costs as long as sponsor companies carefully uphold established evidence and engage in early dialogue with the FDA.
– Boston Biotech Clinical Research (BBCR). Strategic Clinical Innovation Experts. Rare Disease, Clinical Trials, Clinical Research, & Biologics. We work with biotech, pharmaceutical, and device companies to develop clinical/regulatory road-maps consisting with simplified clinical programs, streamlined protocols, and cost-effective clinical trials. Our experienced team provides innovative strategies that meet your goals.
by Boston Biotech Clinical Research | Jan 19, 2023 | Drug Development, Medical Affairs and Clinical Research, Rare Disease, Real World Evidence, Strategy and TPP
Real-world evidence (RWE) is increasingly important in clinical trial design and drug approval.
RWE is clinical evidence related to patient health status and treatment safety and efficacy that are generated in clinical practice. BBCR’s team understands the role RWE plays for Natural History in Rare Diseases. We invite you to be in touch to learn more about your clinical trial needs.
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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.