In this free webinar, gain insight into why eligibility is a high-impact point for protocol deviation prevention. The featured speakers will discuss how to drive protocol compliance with centralized ...

Variables with time-varying effects and the Cox model: Illustration with the role of estrogen receptor status in breast cancer No significant financial relationships to disclose. This is an ASCO ...

The U.S. FDA’s draft guidance for reporting of deviations from clinical study protocols lends some insight as to the definition of a deviation, but the agency highlights some concerns about related ...

Utilizing an automated cloud-based platform, Palantine Foundry, to generate and build large databases for clinical research applications. This is an ASCO Meeting Abstract from the ASCO Breakthrough: A ...

Prior to data collection, this study received approval from the Investigational Review Board and Brigham and Women's Hospital Pharmacy Peer Review Committee. A retrospective chart review was conducted ...

A structured data ownership model—rooted in ICH GCP principles, supported by MHRA and FDA interpretations, and documented in validated system specifications—will enable sponsors to maintain compliance ...

Per-protocol analysis excludes noncompliant clinical trial participants' data. Mixing per-protocol with other analyses gives a clearer intervention picture. Regulators typically reject sole ...