Oracle

Articles

Addressing Roadblocks in Decentralized Trials

May 18, 2021

In a recent virtual roundtable discussion, industry experts Jim Streeter, Alison Holland, Hassan Kadhim, Craig Lipset, Josh Rose, and Craig Serra shared their insight on the challenges faced in implementing decentralized trials and how to address them. Along with the roundtable are video discussions covering the cost and feasibility of a toolkit approach to decentralized trials, the significance of minimizing burden to patients and sites, and the reality of regulatory hurdles.

The Next Domino: Automation, AI, and touchless safety case processing

March 08, 2021

With the increasing volumes of adverse event reports and stagnant budgets, the time is now for a revolutionary change in drug and device safety case management. A robust management process is necessary for identifying and evaluating adverse events (AE) and reporting them properly to regulators.