Search results for: ICH E6 (R3)

Bridge CRF Data Capture & RBQM Analytics for ICH E6(R3) Compliance

As presented at the DIA 2025 Global Annual Meeting: Learn how early, joint CRF and RBQM planning closes critical data gaps Late stage CRF design and last minute RBQM roll-out can affect patient safety oversight and data quality. In this [...]

By |2025-06-18T16:45:40+02:00June 17, 2025|Comments Off on Bridge CRF Data Capture & RBQM Analytics for ICH E6(R3) Compliance

Site Readiness Under ICH E6(R3): Key Guidance for Sponsors

Discover how the finalized ICH E6(R3) guideline elevates site and sponsor collaboration, emphasizing robust training, resource allocation, and digitally empowered data governance.

By |2025-06-18T13:02:55+02:00February 26, 2025|Blog, Free Infographics, News, Resources|Comments Off on Site Readiness Under ICH E6(R3): Key Guidance for Sponsors

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.

By |2025-02-26T14:59:07+02:00January 16, 2025|Blog, Free Infographics, Good Clinical Practice, News, Resources|Comments Off on Adopting ICH E6(R3): What Sponsors, CROs, Sites, and Participants Need to Know

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.

By |2025-01-21T19:30:34+02:00January 9, 2025|Blog, Good Clinical Practice, News|Comments Off on Maximizing Site Readiness for ICH E6(R3)

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.

By |2024-10-31T10:30:22+02:00October 30, 2024|AI in Clinical Trials, Blog, Good Clinical Practice, News|Comments Off on Navigating ICH E6(R3): New Standards for Medical Monitoring

Decoding Sponsor Responsibilities in ICH E6(R3)

Discover the potential impact of the draft ICH E6(R3) guidelines on sponsor responsibilities in clinical trials. Download our free infographic for a comprehensive overview.

By |2024-11-25T19:50:50+02:00May 20, 2024|Good Clinical Practice, News|Comments Off on Decoding Sponsor Responsibilities in ICH E6(R3)

Training Implications of the ICH E6(R3) and E8(R1) Guidelines

Be prepared for ICH E6(R3): turn guidelines into real-world action. In this post, we delve into the key updates and training gaps.

A Comparative Review of the ICH E6(R3) and E8(R1) Guidelines

Unpacking the new ICH guidelines, E6(R3) and E8(R1), we illuminate their key elements, identify gaps, and compare the two in terms of their unity, differences, and complementarity.

By |2024-09-11T16:55:48+02:00May 26, 2023|Blog, Good Clinical Practice, News|Comments Off on A Comparative Review of the ICH E6(R3) and E8(R1) Guidelines

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
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