Risk-Based Monitoring for Clinical Trials – Cyntegrity 2018-07-19T06:27:46+01:00

Holistic Risk-based Quality Mangement

Our RBM.Cloud builds up a “nervous system” of pharmaceutical quality management.

It guarantees early risk identification by providing a centralized location where risk data are

saved, managed, monitored, and reported.

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@RACT

Risk Assessment and Categorization Tool

@RACT

@RACT® – the first free cloud version of Risk Assessment and Categorization Tool, originally developed by TransCelerate Group and improved further by Cyntegrity in cooperation with PPH plus. Register today for free!

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What is RBM

Risk-based Monitoring

What is RBM

Risk-based Monitoring (RBM) is becoming an essential concept in pharmaceutical clinical research today.
Which has potential to reduce clinical costs and improve data quality, and time-to-market of a medicine.

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RBM.cloud

Detect, Manage, Mitigate

RBM.cloud

Detect, Manage, Mitigate
Together with the application EarlyBird® Cyntegrity conducts total risk management of a clinical trial. It analyses data driven KRIs, builds reports and Risk-based Monitoring dashboard.

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 Recent Posts

DIA 2018 Global Annual Meeting: was this year’s theme the most dead-on yet?

July 16, 2018|Comments Off on DIA 2018 Global Annual Meeting: was this year’s theme the most dead-on yet?

The dramatic expansion of prescription drug deaths inspired this year's theme "driving insights to action". Insights that could be deployed through novel disruptive technologies such as Risk-based Quality Management (RBQM). Cyntegrity's Johann Proeve and Nimita Limaye were in Boston and share their observations with us.

Medical Devices: Managing Risks Beyond Bullet Proof Clinical Evidence

June 6, 2018|Comments Off on Medical Devices: Managing Risks Beyond Bullet Proof Clinical Evidence

The EU MDR is setting the stage for busy times ahead. The continuous need for clinical evidence, the increasing complexity of new medical devices, and the size and global nature of medical device trials introduce a greater potential for error. Learn how a risk-based approach enables MedTech manufacturers to better understand, manage and mitigate the growing uncertainties.

Key Risk Indicators Reveal Blind Spots in Clinical Trials

May 15, 2018|Comments Off on Key Risk Indicators Reveal Blind Spots in Clinical Trials

By design, the traditional spot-checking type of audits leave a blind spot on systemic quality threats. Key Risk Indicators however, form the core of a widely applicable concept that captures all relevant risks in scope and provides project managers and QM experts targeted and objective updates on actionable issues and trends.

Latest News

Press Release: Cyntegrity enters the Medical Devices Market

July 10, 2018|Comments Off on Press Release: Cyntegrity enters the Medical Devices Market

Cyntegrity today announced the worldwide release of their Medical Device RACT, “MD-RACT”, the world’s first Risk Assessment and Categorization Tool for clinical investigations, that combines the best practices in Life Sciences with subject matter expertise in Medical Devices.

Interview: “Oncology Trials are Different”

May 3, 2018|Comments Off on Interview: “Oncology Trials are Different”

Many risks in clinical trials seem therapy specific. To illustrate this, Dr Johann Proeve shares real life use cases he experienced during his years as Head of Global Data Management at Bayer HealthCare.

“OncoRACT” – The First Therapy Specific RACT for Clinical Trials

May 1, 2018|Comments Off on “OncoRACT” – The First Therapy Specific RACT for Clinical Trials

Many risks in clinical trials are therapy specific. Because of that, the currently available tools addressing those risks are now becoming therapy specific as well. The first therapy focused risk library Oncology RACT (OncoRACT) recently got available.

Cyntegrity’s RBM Platform “EarlyBird” offers a variety of useful components to support Risk Based Monitoring. I’m looking forward to the first Implementation in one of our next studies.
Steffen Koenig, President at DGGF e.V. (German Society for Good Research Practice), General Manager at IST GmbH
Cyntegrity’s @RACT is not just a cloud-based version of RACT. It is a comprehensive system that follows a solid risk management process. @RACT reinforces that process with in-depth analysis tools to support real-time decision making at both the study and enterprise levels.
Keith Morgenstern, Director Metrics Programs Metrics Champion Consortium
Great that Cyntegrity offers a tool that operationlizes the TransCelerate RACT tool; even better that this enables through a common platform the sharing of risk assessments what will be key to quality risk management as we should learn from IATA!
Beat E. Widler PhD ETH-Z, Managing Partner Widler & Schiemann Ltd.
I think you developed already a great tool, at least from the look and feel point of view. I have no idea how cumbersome the implementation is, how much programming is required etc. I can also imagine that coming to an agreement on what is a risk and the definition for it probably takes most of the time.
Dr. Johann Proeve, Global Development and Strategy Advisor in Global Data Sciences and Analytics at Bayer HealthCare

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