CASE STUDY | Phase III Oncology: Targeted Risk-Based QA
For oncology study teams: see how ADAMAS applied Cyntegrity’s risk signals to focus QA in a global Phase III trial, supporting earlier actions and inspection readiness.
Oct
2025
Oct
2025
MHRA 2025: New Guidance for Medical Device Investigations
The MHRA’s latest guidance clarifies how medical device investigations are managed across Great Britain and Northern Ireland. Cyntegrity helps manufacturers stay inspection-ready with AI-enhanced RBQM tools that strengthen documentation, risk control, and overall data quality from design through post-market follow-up.
Sep
2025
FDA Finalizes ICH E6(R3) Guidance, But U.S. Timeline Still Unclear
The FDA has published the finalized ICH E6(R3) Good Clinical Practice guidance. Unlike Europe’s July 23 deadline, the U.S. implementation date is still to be announced. This creates uncertainty for sponsors and CROs operating across regions, highlighting the importance of early preparation and alignment with global standards.
Jan
2025
Adopting ICH E6(R3): What Sponsors, CROs, Sites, and Participants Need to Know
The ICH E6(R3) guideline was formally adopted on January 6, 2025, introducing reinforced principles for clinical trial conduct. This final version builds on its draft with clarified expectations and some notable revisions. Let’s explore the highlights and the implications for stakeholders.
Jan
2025
Maximizing Site Readiness for ICH E6(R3)
The ICH E6(R3) guideline redefines expectations for clinical trial sites, emphasizing proactive planning, data accuracy, and risk monitoring to enhance participant safety and trial efficiency. Download our presentation for practical insights and strategies to ensure compliance and strengthen collaboration.
Dec
2024
Streamlining Clinical Trials: FDA Guidance Meets RBQM Strategy
The recently launched FDA’s draft guidance on protocol deviations highlights the importance of compliance and risk management. Combined with RBQM principles, sponsors can streamline trials, enhance safety, and align with regulations.
Nov
2024
Empowering Trial Participants: The Right to Access Data and How Sponsors Can Deliver with Ease
Clinical trial participants have the right to access their personal data, a principle emphasized in the ICH E6(R3) guidelines. Sponsors must ensure transparency and provide participants with their data in a clear and accessible format. Our Subject Profiles tool offers a streamlined solution, enabling sponsors to generate comprehensive reports efficiently, thereby meeting regulatory requirements and enhancing participant trust.
Nov
2024
Why Sponsors Should Embed RBQM Principles and Adaptive Monitoring Strategies in Protocol Design
This article explains why sponsors should adopt RBQM principles early in trial planning, supported by regulatory recommendations, and highlights the benefits of early implementation compared to addressing these elements later in the monitoring plan—or not at all.
Oct
2024
Navigating ICH E6(R3): New Standards for Medical Monitoring
Preparing for ICH E6(R3)? Discover how medical monitors can adapt to new safety, compliance, and data integrity standards with advanced monitoring tools.
Sep
2024
EMA Releases New Guidelines for Safe Use of Large Language Models in Regulatory Science
The EMA has released key guidelines on the responsible use of large language models (LLMs) in regulatory science. Discover how AI tools like GPT can streamline tasks while addressing privacy and accuracy challenges, and learn about the EMA’s approach to safe and ethical implementation.