RBQM Updates for Clinical Experts

Oct 2025

CASE STUDY | Phase III Oncology: Targeted Risk-Based QA

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

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

MHRA 2025: New Guidance for Medical Device Investigations

By |2025-10-07T13:30:58+02:00October 7, 2025|AI in Clinical Trials, Good Clinical Practice, News|Comments Off on 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

World Heart Day 2025: Smarter Heart Trials

By |2025-09-29T15:07:21+02:00September 29, 2025|AI in Clinical Trials, Blog, News|Comments Off on World Heart Day 2025: Smarter Heart Trials

On World Heart Day 2025, Cyntegrity highlights the importance of safer, smarter cardiovascular clinical trials. Using the Heart Failure RACT and Risk-Based Quality Management, we help identify patient risks early, improve trial design, and ensure data quality keeping patient safety at the heart of every study.

Sep 2025

Clinical Trials and Patient Safety

By |2025-09-23T16:41:43+02:00September 17, 2025|AI in Clinical Trials, Blog, News|Comments Off on Clinical Trials and Patient Safety

Every 17 September, World Patient Safety Day reminds our industry that safety is not just an outcome, it’s a discipline. In clinical research, safety begins long before first-patient-in and continues with every data point captured, every deviation resolved, and every monitoring decision made.

Sep 2025

FDA Finalizes ICH E6(R3) Guidance, But U.S. Timeline Still Unclear

By |2025-09-11T14:39:25+02:00September 9, 2025|Good Clinical Practice, News|Comments Off on 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.

Aug 2025

Law of Attraction & Power of Imagination

By |2025-09-18T16:26:22+02:00August 22, 2025|Blog|Comments Off on Law of Attraction & Power of Imagination

In our community learning session with Giray Görbil (Clinical Marketing Coordinator at Cyntegrity), we explored the fascinating connection between the "Law of Attraction and the Power of Imagination". These two concepts, when combined, can unlock new ways of thinking, creating, and shaping our personal [...]

Jul 2025

Selling Across Cultures: Pitching to Global Clients

By |2025-09-18T16:31:05+02:00July 24, 2025|Blog|Comments Off on Selling Across Cultures: Pitching to Global Clients

In today’s global market, success isn’t just about offering a great product or service it’s about connecting with people from different cultures in a meaningful way. The latest Community Learning Session with Julien Goncalves (Head of Growth at Cyntegrity) shared valuable insights during his [...]

Jul 2025

3rd Annual ACDM Symposium 2025

By |2025-07-21T16:38:29+02:00July 21, 2025|Comments Off on 3rd Annual ACDM Symposium 2025

Join Cyntegrity at the ACDM RBQM Symposium 2025 in Amsterdam! Don’t miss Johann Proeve’s expert talk on ICH E6(R3), E8(R1), and CDM evolution.

Jun 2025

SCOPE Europe Summit 2025, Barcelona

By |2025-07-29T09:45:51+02:00June 24, 2025|Comments Off on 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.

Jun 2025

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

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

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.

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