01.04.21 -- New Manuscript Examines FDA's Use OF RWE In Drug Approvals

As the pandemic has made on-site inspections challenging across most of the world, remote inspections have become vital to keeping studies moving forward. How does this change the way we prepare for inspections, and how do we address the new challenges a remote inspection could bring?

Understanding the FDA audit process, preparing for it, and being aware of regulations will help to restore a sense of control and help to ensure the best outcome.

Coastal Pediatric Research (CPR) was well aware of the eRegulatory trend that was surfacing. Before CPR selected a platform, the team gave some thought to what they wanted an eRegulatory system to contain and/or provide. Learn more about the criteria for their selection and what solution met their criteria.

Biopharma organizations are under increasing pressure to effectively leverage an expanding set of research, clinical, operational, and real-world data (RWD) to accelerate their trials and improve their chances of successfully launching new drugs. In this e-book, discover how to improve study success rates, optimize study design, accelerate enrollment, monitor performance against similar trials, and uncover issues for early remediation with Intelligent Trials.

In Q4 2019, ISR asked sponsors who outsource Phase 1 trials to better understand customer loyalty. CRO loyalty is computed as an index that consists of likelihood to recommend, likelihood to use again, and overall satisfaction. The data below show companies with twenty or more user ratings over the past three years and an industry average derived from all CROs included in the research.