Oracle

Articles

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.

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

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.

Virtual, Decentralized, Site-less Trials …What Does it All Mean

Virtual elements in clinical trials require extra considerations All teams involved should maintain ongoing dialogue and collaboration for success A discussion with industry leaders provides insight into such trials

Three Key Critical Considerations Before Embarking on Decentralized Trials

- Clinical trials can be designed across a continuum of formats. - Adding decentralized elements to trials can help acquire high-quality data. - Sponsors must understand the impact across the trial landscape for success.