Understanding the transformative impact of ICH E6(R3) guidelines on clinical trial oversight and quality management. Introduction In the ever-evolving landscape of clinical trials, the recent update to the ICH E6(R3) Good Clinical Practice (GCP) guidelines...
At ADAMAS, we don’t just interpret regulatory change—we help you lead through it. The transition to ICH E6(R3) isn’t business as usual. With its emphasis on risk-based quality, patient-centricity, and data integrity, this revision marks a fundamental shift in how...
We’re excited to showcase ADAMAS Consulting’s proven Risk-Based Quality Assurance (RBQA) process—designed to help sponsors meet the evolving requirements of ICH E6 (R3) with confidence. Compliance: Our structured, seven-step RBQA approach ensures full alignment with...
Discover how ADAMAS helped a sponsor prepare for inspection using a targeted risk-based approach Our latest case study highlights how ADAMAS Consulting supported a leading pharmaceutical company in proactively identifying high-risk sites during a global Phase III...
ADAMAS Consulting’s webinar, “GCP ICH E6 R3 Unveiled: Navigating the Evolving Roles of Sponsors and CROs,” provides invaluable insights into the evolving landscape of Good Clinical Practice (GCP) guidelines. Experts discuss key updates to ICH E6 R3 and how Sponsors...
The implementation of the Windsor Framework on January 1, 2025, marked a significant regulatory milestone for the UK pharmaceutical industry, particularly in pharmacovigilance (PV). For the first time, the Medicines and Healthcare Products Regulatory Agency (MHRA)...
Navigating ICH E6(R3): A New Era for Clinical Trials
Insights and Compliance Strategies for Pharmacovigilance Under the Windsor Framework
ADAMAS Consulting Strengthens Resources in APAC
DIA 2025 Global Annual Meeting | Washington, DC
Come and meet ADAMAS Consulting at the RQA International QA Conference, Brighton