Blog

May 2023

Enhancing R&D Due Diligence in Pharma M&As: The Role of MyRBQM Portal

By |2024-06-07T15:19:19+02:00May 10, 2023|Blog, M&A Insights and Solutions, News|Comments Off on Enhancing R&D Due Diligence in Pharma M&As: The Role of MyRBQM Portal

Navigate your M&A journey confidently with Cyntegrity's MyRBQM Portal. Aspiring to hit your targets within 6-12 months? Discover how we can make it possible in R&D due diligence.

Apr 2023

Global Impact of COVID-19 Pandemic on Clinical Trials

By |2023-04-20T12:38:49+02:00April 19, 2023|Blog, News|Comments Off on Global Impact of COVID-19 Pandemic on Clinical Trials

Wondering how the COVID-19 pandemic has impacted clinical trials worldwide? The COVID-19 pandemic has brought unprecedented challenges to the healthcare industry worldwide. The clinical trial sector has been no exception, and it has undergone significant changes over the past few years. From the [...]

Mar 2023

Synergy of QbD, RBM, and RBQM in Trials

By |2024-06-14T17:44:33+02:00March 20, 2023|Blog, News|Comments Off on Synergy of QbD, RBM, and RBQM in Trials

Clinical trials require a comprehensive approach to ensure quality and efficiency. Quality by Design, Risk-Based Monitoring, and Risk-Based Quality Management work together to achieve these goals, focusing on building quality into the trial process, targeting monitoring activities, and continuously improving trial quality.

Mar 2023

Patient Safety in Clinical Trials

By |2023-03-14T19:28:35+02:00March 14, 2023|Blog|Comments Off on Patient Safety in Clinical Trials

What is the future of patient safety in clinical trials? The life sciences industry is experiencing an evolution. Technology is forcing digital transformation and is rapidly changing the way that companies conduct research, test treatments, and evaluate data. To continue this progress, industry experts [...]

Mar 2023

Why the Industry Finds It Easier to Embrace Key Risk Indicators than Quality Tolerance Limits

By |2023-03-14T12:51:19+02:00March 14, 2023|Blog, News|Comments Off on Why the Industry Finds It Easier to Embrace Key Risk Indicators than Quality Tolerance Limits

This opinion piece by Keith Dorricott, MBB, addresses the challenges faced by the clinical trial industry in implementing QTLs and KRIs as required by ICH E6(R2). The article explores why KRIs have been easier to adopt than QTLs and wonders if the specific guidance provided by ICH E6(R2) is partly responsible.

Mar 2023

What’s the Difference Between RBQM and QRM in Clinical Trials?

By |2024-06-14T18:09:56+02:00March 6, 2023|Blog, News|Comments Off on What’s the Difference Between RBQM and QRM in Clinical Trials?

In clinical trials, managing risks that could impact data quality is crucial for ensuring patient safety, data integrity, and regulatory compliance. While Risk-Based Quality Management (RBQM) and Quality Risk Management (QRM) are both approaches designed to manage risks, the two have essential differences.

Feb 2023

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

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

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)!

Feb 2023

Cyntegrity’s Drug Interaction Visualizer: Finalist for SCOPE Awards

By |2023-02-04T12:39:34+02:00February 4, 2023|Blog, News|Comments Off on Cyntegrity’s Drug Interaction Visualizer: Finalist for SCOPE Awards

We are proud to announce that our Drug Interaction Visualizer has been selected as a finalist for the SCOPE Best of Show Awards. Based on real-world data from the FDA, our visualizer enables clinical research professionals to explore drug interactions and identify potential risks.

Jan 2023

How the Premortem Can Improve the Success of Clinical Trials

By |2023-01-24T11:30:18+02:00January 24, 2023|Blog, News|Comments Off on How the Premortem Can Improve the Success of Clinical Trials

Learn about the high failure rate of clinical trials & how the premortem approach can improve success by identifying potential problems early. Discover how this technique can foster a culture of collaboration & learning within the team, reducing the need for a painful postmortem.

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