News

Over the past year and a half we have been monitoring the trend towards adoption of risk-based monitoring across the industry, and in particular the move towards reduced source document verification (SDV).

GLOBAL TRIALS : Is Guatemala the Next Research Hotspot? SITES : Trials in Limited Resource Settings Also in this issue : New User Fees, Declining European Trials, Low Trial Results Reporting, Risk-Based Approach to Monitoring

The responsibilities regarding CV safety for drug developers are constantly evolving.

Tufts Center for Drug Development

Often CNS trial subjects face unique obstacles like mental dependency

Examining the challenges and solutions to the implementation of trials in resource-limited settings.

A case study of how cardiac safety assessments can be enhanced with Holter Bin.

Why biotechs need to use a more systematic approach and catch up with pharma.

Clinical R&D organizations across the industry have been steadily moving away from the traditional approach to site monitoring using 100% source document verification (SDV) of subject eCRFs, and into a new paradigm where a targeted sampling of the subject eCRF data is verified against source charts.