Oracle

Articles

Understanding the role of the investigator in decentralized trials

Tuesday, March 29, 2022 at 1 pm EST, 12 pm CST, 10 am PST The popularity of decentralized clinical trials (DCTs) is making oversight of investigators more critical. As trial operations spread and become more remote, the role of the investigator as a center of gravity becomes increasingly vital. Approaching regulatory agencies to understand if there are regulatory issues with a proposed DCT solution will likely lead to more non-standardized regulations, which in turn creates additional regulatory uncertainty. What can be done?

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.

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.

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.