Blog

Jan 2019

Infographic: Quality Tolerance Limits vs. Key Risk Indicators

By |2019-01-18T18:37:50+00:00January 18, 2019|Blog, Infographic|Comments Off on Infographic: Quality Tolerance Limits vs. Key Risk Indicators

Since the release of ICH GCP E6 R2 Addendum, there is a large confusion in the pharma industry, what is the difference between Quality Tolerance Limits (QTLs) and Key Risk Indicators (KRIs). The ICH stated: Predefined quality tolerance limits should be established, taking into consideration [...]

Nov 2018

Are Clinical Trials Safe? 6 Questions to Ask Before Enrolling

By |2018-11-27T16:53:22+00:00November 27, 2018|Blog|Comments Off on Are Clinical Trials Safe? 6 Questions to Ask Before Enrolling

If you are thinking about joining a clinical research study, then you might wonder about the safety risks you should be aware of, as no clinical trial is completely safe for everyone.

Nov 2018

Patient Profiles – Better Understand Your Patients

By |2018-11-20T10:25:21+00:00November 1, 2018|Blog, RBM Product Updates, Weekly RBM Feature|Comments Off on Patient Profiles – Better Understand Your Patients

Pharma today embraces the concept of patient-centered research. Innovators view Patients as informed collaborators whose participation is core to the overall success of clinical research. The risk-based Patient Profiles tool is a key contributor to the modern concept of patient-centered thinking, as It enables early detection and real time control of patient safety issues.

Oct 2018

Data Integration – A Valid Concern or a Convenient Excuse?

By |2018-10-15T15:10:53+00:00October 11, 2018|Blog, Conferences|Comments Off on Data Integration – A Valid Concern or a Convenient Excuse?

Conference season has started! Our first stop was the Global RBM Summit 2018 in London. Our CSO Dr Johann Proeve was invited to join the conversation as a speaker on the topic “Pragmatic Centralized Monitoring – How to get there?”. Johann shares his observations with us.

Sep 2018

Optimizing Adverse Event Capturing and Reporting – 7 Questions to Ask

By |2018-09-20T06:40:12+00:00September 18, 2018|Blog|Comments Off on Optimizing Adverse Event Capturing and Reporting – 7 Questions to Ask

Adverse Event (AE) reporting, identified by the FDA as one of the most important challenges in clinical research, is known to be prone to under and over-reporting. When starting a project and considering the various ways available to capture the adverse event data, it’s important to ask yourself some analytical questions that help you improve AE and SAE capturing and reporting.

Jul 2018

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

By |2018-07-17T09:10:07+00:00July 16, 2018|Blog|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.

Jun 2018

Medical Devices: Managing Risks Beyond Bullet Proof Clinical Evidence

By |2018-12-14T08:14:33+00:00June 6, 2018|Blog, Weekly RBM Feature|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.

May 2018

Key Risk Indicators Reveal Blind Spots in Clinical Trials

By |2018-05-16T09:02:30+00:00May 15, 2018|Blog|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.

May 2018

Interview: “Oncology Trials are Different”

By |2018-10-02T05:41:24+00:00May 3, 2018|Blog, News|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.

May 2018

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

By |2018-05-03T13:07:48+00:00May 1, 2018|Blog, News|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.

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