Articles tagged with “gcp-guidelines”

Investigator-Initiated Trials (IITs): A Guide to Sponsorship

Learn what Investigator-Initiated Trials (IITs) are and the regulatory responsibilities clinicians face as a Sponsor-Investigator in academic clinical trials.

40 min read

11/22/2025

investigator initiated trial sponsor-investigator clinical trial sponsorship academic clinical trials gcp guidelines fda regulations ind application

Clinical Trial Site Selection: Key Factors & Best Practices

Learn the key factors CROs use for clinical trial site selection. This guide covers patient recruitment, feasibility assessments, and data-driven methods for su

35 min read

11/20/2025

clinical trial site selection cro services feasibility assessment patient recruitment clinical trial management investigator selection gcp guidelines

ICH E6(R3) Explained: Key Changes to GCP Guidelines

Explore the updated ICH E6(R3) Good Clinical Practice (GCP) guideline. Learn about the key changes from R2, the new structure with Annex 1 & 2, and risk managem

50 min read

11/13/2025

ich e6 r3 good clinical practice gcp guidelines ich e6 r2 vs r3 risk-based quality management decentralized trials clinical trial compliance data governance

ICH E6(R3) Explained: A Guide to the 2025 GCP Update

An in-depth analysis of the ICH E6(R3) Good Clinical Practice guidelines for 2025. Explore key changes in Quality by Design, data governance, and decentralized

35 min read

10/13/2025

ich e6(r3)good clinical practice gcp guidelines clinical trials quality by design decentralized trials data governance regulatory compliance