Features

Are Clinical Trials Headed for Tech Disruption?

November 5, 2018

Stanford University researchers last week announced they had enrolled 400,000 patients in a clinical trial to test whether an app on the new Apple Watch can effectively screen for a heart-rhythm disorder.

BIMO Official Gives Site Inspection Update, Tips

October 29, 2018

BETHESDA, Md. — Inspections by the FDA’s Office of Bioresearch Monitoring Operations (BIMO) will soon become more consistent from one trial site to another thanks to a major program alignment, says BIMO’s deputy director.

FDA: Data Management Plans Key for Trials

October 29, 2018

Clinical data management plans aren’t mentioned in FDA regulations, but don’t be fooled – they’re a key ingredient in winning product approval. So don’t just shrug them off, says a top agency official.

Brexit Boggles UK Trials

October 22, 2018

The number of clinical trials in the UK has plummeted amid growing anxiety over uncertainties linked to Brexit.

Adverse Event Reporting: When TMI is Risky

October 15, 2018

As sponsors and sites have expanded their global reach, they’ve run into myriad local and regional regulations requiring them to report adverse events in their clinical trials. Hoping to simplify, many sponsors or sites have tried to create a one-size-fits-all form that sends out nearly automated alerts for nearly every single glitch.