Founded in 2015, Decibel is a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance. For this growth-stage biotech, Egnyte has been a valuable partner in supporting clinical and regulatory operations, medical writing, biostatistics and data management teams with a single repository for all documentation gathered from CROs and submitted to the FDA and other regulatory agencies.
Mobile Visits in Decentralized Clinical Trials: The Past, Present and Future
May 7th 2024In March 2024, the US FDA issued its guidance, “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together,” outlining the agency’s objectives for protecting public health as artificial intelligence (AI) and other technologies become more prevalent in healthcare.
Digital Biomarkers Solution shows pathway to reduced clinical trial sample sizes, shorter durations
April 5th 2024Digital biomarkers provide a pathway to the future where clinical trial sponsors can potentially benefit from reduced trial duration and sample size. Learn more about these benefits from a simulated study.