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.

Smarter Signal Management: AI, big data, and predictive analytics

March 05, 2021

What if you could predict potential safety issues before clinical development begins? Innovative new signal detection and management approaches have been developed to help clinical trial sponsors, manufacturers, and CROs combat safety-related challenges and provide insight to be used to predict potential safety issues even before clinical development begins. Applying those learnings to their choice of initial research candidates can ultimately mean safer medicines for patients.

2020 Research Explores Clinical Trial Design and Data Collection in the New Paradigm

November 19, 2020

***Live: Thursday November 19, 2020 11am EST | 8am PST | 4pm GMT | 5pm CET***Join this webcast to hear the results of an industry-wide survey on the impact of the Covid-19 pandemic on clinical data collection and clinical operations. Learn how your peers have accelerated their plans to shift to a decentralized clinical trial model, and understand the benefits and challenges that come with this transition. ***On demand available after final airing until Nov. 19, 2021***