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Nov 2024

Empowering Trial Participants: The Right to Access Data and How Sponsors Can Deliver with Ease

By |2024-11-25T15:21:25+02:00November 25, 2024|Blog, Good Clinical Practice, News|Comments Off on Empowering Trial Participants: The Right to Access Data and How Sponsors Can Deliver with Ease

Clinical trial participants have the right to access their personal data, a principle emphasized in the ICH E6(R3) guidelines. Sponsors must ensure transparency and provide participants with their data in a clear and accessible format. Our Subject Profiles tool offers a streamlined solution, enabling sponsors to generate comprehensive reports efficiently, thereby meeting regulatory requirements and enhancing participant trust.

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Nov 2024

Why Sponsors Should Embed RBQM Principles and Adaptive Monitoring Strategies in Protocol Design

By |2024-11-20T18:27:43+02:00November 19, 2024|Blog, News|Comments Off on Why Sponsors Should Embed RBQM Principles and Adaptive Monitoring Strategies in Protocol Design

This article explains why sponsors should adopt RBQM principles early in trial planning, supported by regulatory recommendations, and highlights the benefits of early implementation compared to addressing these elements later in the monitoring plan—or not at all.

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Oct 2024

Navigating ICH E6(R3): New Standards for Medical Monitoring

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

Preparing for ICH E6(R3)? Discover how medical monitors can adapt to new safety, compliance, and data integrity standards with advanced monitoring tools.

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Oct 2024

Cyntegrity Boosts Clinical Trial Efficiency with MongoDB Atlas

By |2024-10-23T13:33:07+02:00October 23, 2024|News|Comments Off on Cyntegrity Boosts Clinical Trial Efficiency with MongoDB Atlas

Cyntegrity leverages MongoDB Atlas to transform clinical trials, enhancing data integrity and accelerating drug development. Our AI-augmented MyRBQM® Portal empowers study teams to detect risks early, optimize costs, and ensure regulatory compliance, setting a new standard for safer, faster research. Discover how we’re driving the future of clinical trials.

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Oct 2024

ISO 9001:2015 Renewal – Strengthening Quality in Clinical Research

By |2024-10-17T15:56:18+02:00October 17, 2024|Blog, News|Comments Off on ISO 9001:2015 Renewal – Strengthening Quality in Clinical Research

Cyntegrity is proud to announce the renewal of our ISO 9001:2015 certification. This renewal highlights our commitment to maintaining the highest standards of quality in clinical research, ensuring consistency, risk management, and regulatory compliance. Discover how this certification continues to drive our mission for excellence.

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Sep 2024

EMA Releases New Guidelines for Safe Use of Large Language Models in Regulatory Science

By |2024-09-19T14:22:20+02:00September 19, 2024|AI in Clinical Trials, Good Clinical Practice, News|Comments Off on EMA Releases New Guidelines for Safe Use of Large Language Models in Regulatory Science

The EMA has released key guidelines on the responsible use of large language models (LLMs) in regulatory science. Discover how AI tools like GPT can streamline tasks while addressing privacy and accuracy challenges, and learn about the EMA’s approach to safe and ethical implementation.

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Sep 2024

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

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

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).

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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.

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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. [...]

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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!

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