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Are CROs Prepared for ICH E6 (R3)?

Monday, September 27, 2021 at 1pm EDT | 12pm CDT| 10am PDT ICH E6 (R3) introduces the concepts of Quality by Design (QbD) and critical thinking, specifically calling for establishing a culture that supports critical thinking and open dialogue about quality that goes beyond reliance on tools and checklists. As CROs fight to maintain market share and ensure long-term survival, those companies able to take these steps may by well-positioned to reap the rewards.

Addressing Roadblocks in Decentralized Trials

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

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.