Clear, well-referenced articles on clinical research, drug safety, regulatory affairs and clinical data — written for students and professionals moving from academia into the healthcare industry.
ICH E6(R3) replaces R2 with a risk-proportionate, quality-by-design approach to GCP. Here is what changed, key dates, and what CRAs, CRCs and sponsors should do next.
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Decentralized clinical trials move study activities closer to participants. Learn what FDA's 2024 guidance and ICH E6(R3) Annex 2 require, and the skills trial teams need.
AI is changing case processing and signal detection in pharmacovigilance. Here is what the CIOMS Working Group XIV principles say, and what drug safety professionals should know.
A regulatory affairs guide to FDA's draft guidance on AI in drug development, its seven-step credibility framework, and the joint FDA-EMA Good AI Practice principles.
How SDTM, ADaM and define.xml get clinical trial data to the FDA, what the R Submissions pilots showed, and why Clinical SAS skills remain in demand.
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