Topic

Articles

Overall rate of significant KRI results for sites located in Ukraine has consistently risen since 2021.

Ukraine War's Impact on Clinical Research: Evidence from Key Risk Indicators

Collaboration and regulation were the watchwords at DIA Global this year, where the ICH E6(R3) guideline, published in final draft form in May, was the talk of the congress.

ICH E6(R3) Ushers in the Risk Based Quality Management Era – But Are We Ready?

Comprehensive Research Associates, Houston, TX, USA

Study Health Check provides early identification of issues related to protocol deviations and determines objective measures of site-specific versus study-wide performance.

Oversight Method Identifies Critical Errors Missed by Traditional Monitoring Approaches

Metric derived from CluePoints central monitoring platform assesses average total cycle time from risk signal creation until closure.

Industry Trends: Cycle Time to  Resolve Risk Signals

Strategies for intervention—or, ideally, averting potential pitfalls from the onset.

How to Rescue ‘Failed’ Clinical Trials and Minimize Risks

Associate Director, Statistical Science, PPD, the clinical research business of Thermo Fisher Scientific

Director, Statistical Science, PPD, the clinical research business of Thermo Fisher Scientific

Senior Director, Statistical Science, PPD, the clinical research business of Thermo Fisher Scientific

Associate Director, Centralized Monitoring, PPD, the clinical research business of Thermo Fisher Scientific

Statistical methods used via this technique in centralized monitoring.

Harnessing the Power of Scientific Surveillance

Webcasts

Leveraging RBQM Technology to Enable Sponsor-Level Clinical Trial Oversight

As challenges like regulatory adherence, cost, and timelines become more complex, sponsors are seeking out new ways to incorporate risk-based approaches.

The Role of KRIs in Process-Driven RBQM Success

Industry sees high increase in the use of QTLs.

Quality Tolerance Limits: A Review of Industry Trends

Webinar Date/Time: Mon, Feb 13, 2023 10:00 AM EST


Risk-Based Monitoring