Articles tagged with “ich-e6”

Learn the key differences between ISO 14155 for medical device trials and ICH GCP for pharma. This guide compares their scope, risk management, and regulatory c

Learn what an Investigator's Brochure (IB) is, its required content per ICH GCP guidelines, and its critical role in assessing risk for clinical trials.

Learn about Veeva Vault eTMF, the leading electronic trial master file solution. This guide covers features, architecture, and compliance with ICH E6 & 21 CFR P