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Initiative Overview – Privacy Methodology for Data Sharing

This overview provides the background of the Privacy Methodology for Data Sharing initiative which is seeking to assist identify a model approach to implementing privacy safeguards that will provide increased transparency and enable simpler utilization of clinical trial data re-use.

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A Toolkit for ICH-E6(R3)

Released at the start of 2025, the ICH-E6(R3) guideline is an updated international standard for how clinical trials should be designed, conducted, recorded, and reported. At its core, the guideline ensures that people who participate in clinical trials are kept safe and that the data collected is reliable and meaningful. This guideline is not a…

Expanding clinical trial access through technology, support

Clinical trials are a key tool for producing the safety and efficacy data that guide new therapies to market. Progress in clinical research relies on those who volunteer to participate, and yet, access to trials is not the same for everyone in the United States. Read the full article featuring Allison Cuff Shimooka from TechTarget…

Good Clinical Practice has Changed: Are You Ready for ICH-E6(R3)?

ICH-E6(R3) represents a shift in mindset when it comes to clinical trials. Rather than trying to control every part of a trial equally, the guideline wants researchers to focus most on factors that are critical to participant safety and the reliability of trial results. It introduces the idea of “proportionality,” meaning more control is applied…