Search results for: ICH E6 (R3)

Reflections on ICH E6(R3): Insights from SCOPE Summit 2023

Exciting news on ICH GCP E6(R3) is here! Our CEO, Artem Andrianov, returned from the SCOPE Summit with updates on the updated guideline. ICH E6(R3) will incorporate technology advancements while prioritizing participant protection and reliable evidence. Don't miss Artem's thoughts on his experience at the summit. Stay tuned for more updates on ICH E6(R3)!

By |2024-09-11T16:56:32+02:00February 13, 2023|Blog, Good Clinical Practice, News|Comments Off on Reflections on ICH E6(R3): Insights from SCOPE Summit 2023

Preparing for the Transition to ICH E6 R3 – Key Sponsor Responsibilities

With the ICH E6(R3) guideline set for approval by October 2024, sponsors face new requirements in risk management, RBQM, and data integrity. Stay compliant and efficient by downloading our free infographic that highlights the key differences between ICH E6(R2) and E6(R3).

By |2024-11-25T19:43:54+02:00September 11, 2024|Free Infographics, Good Clinical Practice, News|Comments Off on Preparing for the Transition to ICH E6 R3 – Key Sponsor Responsibilities

Decoding the ICH’s Q9(R1) Quality Risk Management Guideline

Explore the impact of ICH's Q9(R1), Quality Risk Management, guideline on RBQM and clinical trials in our latest blog post. Don't miss our free infographic that simplifies this complex guideline. Enhance your risk strategies today!

By |2025-03-21T13:48:52+02:00December 4, 2023|Blog, Free Infographics, Good Clinical Practice, News, Resources|Comments Off on Decoding the ICH’s Q9(R1) Quality Risk Management Guideline

How to Build Critical to Quality Trees for Clinical Research

Building Critical to Quality Trees helps you to translate critical study needs and quality drivers into measurable outcomes and processes. Initially, this Lean Six Sigma approach serves as a business tool based on customer needs. Still, it is a helpful method of implementing Quality by Design in clinical research.

By |2024-11-25T18:15:45+02:00July 29, 2021|Blog|Comments Off on How to Build Critical to Quality Trees for Clinical Research

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.

By |2025-10-09T09:13:57+02:00October 9, 2025|Case Studies, Good Clinical Practice, News|Comments Off on CASE STUDY | Phase III Oncology: Targeted Risk-Based QA

3rd Annual ACDM Symposium 2025

Cyntegrity at ACDM RBQM 2025: Artem Andrianov & Johann Proeve share insights on CDM evolution, RBQM, and MyRBQM Portal for safer, reliable trials.

By |2025-10-27T17:48:00+02:00July 21, 2025|Comments Off on 3rd Annual ACDM Symposium 2025

SCOPE Europe Summit 2025, Barcelona

Join Cyntegrity at SCOPE 2025 Barcelona, Booth #4, and explore how AI-powered RBQM cuts review cycles by 30% and boosts inspection readiness.

By |2025-07-29T09:45:51+02:00June 24, 2025|Comments Off on SCOPE Europe Summit 2025, Barcelona

DIA 2025 Posters: Rare-Disease & CRF-RBQM Wins

Download our DIA 2025 posters and see how upfront RBQM—applied to rare-disease trials and joint CRF design—sharpens data quality, elevates patient safety, and keeps studies ICH E6(R3)-ready.

By |2025-06-18T11:50:04+02:00June 18, 2025|Case Studies, News, Resources|Comments Off on DIA 2025 Posters: Rare-Disease & CRF-RBQM Wins
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