ANVISA Publishes 2024–2025 Good Clinical Practice Inspection Metrics: What Clinical Trial Sponsors and Manufacturers Should Know
ANVISA’s new 2024–2025 GCP inspection report highlights critical findings in clinical trials, data integrity, electronic systems, SOPs, and investigational product management. Learn what manufacturers and sponsors should review.
FDA launches consultation on AI use in early-phase clinical trials
FDA opens consultation on a pilot program to assess artificial intelligence in early-phase clinical trials, focusing on efficiency, safety, and decision-making.
MHRA aligns Declaration of Helsinki with UK Clinical Trial Regulations: What manufacturers need to know
MHRA clarifies alignment between the Declaration of Helsinki and amended UK Clinical Trial Regulations effective April 2026. Key impacts for sponsors and manufacturers.
MHRA Updates Guidance on Archiving and Retention of Clinical Trial Records
MHRA updates clinical trial record retention rules to 25 years. Key implications for manufacturers, TMF management, and UK regulatory compliance.
FDA Releases Draft Guidance on Bayesian Methodology in Clinical Trials – What It Means for Innovative Study Designs
FDA releases draft guidance on Bayesian methods in clinical trials. Learn how device manufacturers can benefit from this innovative approach.
FDA publishes new M11 technical specification for electronic harmonized clinical protocols (CeSHarP)
The FDA's new M11 technical specification, developed within the framework of ICH, defines a structured and harmonized electronic template for clinical protocols - CeSHarP. This document promotes the international standardization of clinical trial documentation, facilitating electronic submission and regulatory interoperability between agencies such as the FDA, EMA and PMDA.