RBQM Updates for Clinical Experts

Sep 2024

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

By |2024-09-12T13:34:22+02:00September 11, 2024|Free Infographics, Good Clinical Practice, News|Comments Off on 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).

Aug 2024

SCOPE Barcelona 2024

By |2024-09-09T15:26:17+02:00August 28, 2024|Comments Off on SCOPE Barcelona 2024

Celebrate our 10th anniversary with exclusive gifts, including the signed 2024 RBQM Guide by the authors and more fun giveaways!

Aug 2024

The Real Cost of Delays in Drug Development and the Role of RBQM and QbD

By |2024-08-08T10:52:32+02:00August 8, 2024|Blog, News|Comments Off on The Real Cost of Delays in Drug Development and the Role of RBQM and QbD

Recent Tufts CSDD research shows that the cost of clinical trial delays is much lower than previously thought, underscoring the importance of Risk-Based Quality Management (RBQM) and Quality by Design (QbD). Cyntegrity's Johann Proeve, PhD, and Anastasia Shapovalova, MSc, highlight the benefits of a data-driven approach and live process monitoring in enhancing trial efficiency.

Jul 2024

Enhancing Phase 1 Trials with Risk-Based Quality Management

By |2024-07-31T16:17:54+02:00July 31, 2024|Blog, News, Phase 1 - FIH|Comments Off on Enhancing Phase 1 Trials with Risk-Based Quality Management

The Importance of First-in-Human (FIH) Trials First-in-Human (FIH) clinical trials, also known as Phase 1 trials, are a pivotal stage in drug development. Conducted with a small group of healthy volunteers, these studies mark the first testing of a new drug in humans. [...]

Jul 2024

How We Support Global SDGs and Social Impact

By |2024-07-11T18:12:17+02:00July 11, 2024|Blog, Butterfly Challenge, News|Comments Off on How We Support Global SDGs and Social Impact

At Cyntegrity, our remote work model supports the UN's Sustainable Development Goals (SDGs) by promoting inclusivity, reducing environmental impact, and fostering social responsibility through initiatives like the Butterfly Challenge. Join us in making a positive global impact!

Jun 2024

Understanding Time-Series Data in MyRBQM® Portal Introduction

By |2024-06-24T20:19:55+02:00June 24, 2024|Blog, Neat Features, News|Comments Off on Understanding Time-Series Data in MyRBQM® Portal Introduction

Discover how the MyRBQM® Portal uses advanced time-series data storage to preserve every data point in its original context, enhancing Risk-Based Quality Management (RBQM) by allowing you to track study progress and understand past decisions.

Jun 2024

5 Questions to Ask When Comparing RBQM Systems

By |2024-07-11T18:28:10+02:00June 20, 2024|Blog, Neat Features, News|Comments Off on 5 Questions to Ask When Comparing RBQM Systems

When evaluating Risk-Based Quality Management (RBQM) systems, asking the right questions is crucial to ensure you choose a solution that meets your needs and aligns with regulatory guidelines. This post outlines five key questions to consider.

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