Changing the Pace of the FDA's Standard Review: Part Two

To truly achieve inclusivity and patient centricity, overcoming legacy concerns about data comparability is key to embracing accessibility standards in electronic clinical outcome assessment.

In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.

As clinical trials navigate a digitized future, it’s not enough to simply identify the right patients—we must understand what drives those individuals along the path to active participation.

Recent analysis explores AI's momentum in drug development, showcasing rapid adoption and significant time savings, despite challenges in trust and data governance.

Overcoming the illusion of knowledge in clinical research can enhance decision-making, training, and project success—helping ensure trials run smoothly and effectively.