ICH Guidelines

Understanding ICH E8(R1) on Clinical Trial Quality and Efficiency

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Originally adopted in 1997, ICH E8 provided general considerations for clinical trials. With the evolution of trial complexity—ranging from personalized medicine to decentralized models—a revised framework was required to ensure both quality and regulatory compliance. Released in 2021, ICH E8(R1) aligns with other guidelines like E6(R3) and E17, promoting a harmonized approach to trial conduct across global jurisdictions.
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ICH Guidelines, Regulatory Guidelines

ICH E6(R3): Major Updates and What They Mean for Clinical Trials

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The current ICH E6(R2) guidance was adopted in 2016 and primarily addressed electronic systems and sponsor oversight. However, as clinical trials rapidly advanced into digital and decentralized formats, it became evident that a broader framework was necessary. The emergence of technologies like eConsent, remote monitoring, and real-world data called for a more agile, principle-based model of GCP.
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ICH Guidelines, Regulatory Guidelines