Blog

Jun 2018

Medical Devices: Managing Risks Beyond Bullet Proof Clinical Evidence

By |2018-12-14T08:14:33+00:00June 6, 2018|Blog, Neat Features|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.

Mar 2018

Adaptive Monitoring: Anticipating The Human Factor

By |2018-03-21T19:31:12+00:00March 21, 2018|Blog, Case Study|Comments Off on Adaptive Monitoring: Anticipating The Human Factor

An effective way to control risks during a clinical trial is to anticipate events induced by human factor before the study even begins. Dr Johann Proeve's third chapter on Adaptive Monitoring talks about how human factor is complementary to numeric data.

Mar 2018

The Three Biggest Challenges in RBM Related to Key Risk Indicators

By |2018-03-14T17:33:53+00:00March 14, 2018|Blog|Comments Off on The Three Biggest Challenges in RBM Related to Key Risk Indicators

Our online KRI (Key Risk Indicator) survey indicated that finding the right calculation method seems the most challenging aspect of the application of KRIs. In addition our survey showed that the vast majority (> 95%) makes use of KRIs. Do these results surprise you?

Mar 2018

Adaptive Monitoring: Beyond Data Trends and Timely Performance

By |2018-06-03T14:21:15+00:00March 7, 2018|Blog, Case Study|Comments Off on Adaptive Monitoring: Beyond Data Trends and Timely Performance

Adaptive Monitoring is not a “status quo”, it is a dynamic response to clinical research that drives monitoring scope and activities to the evolving areas of greatest need which have the most potential to positively impact. Each clinical study requires its own tailored monitoring approach ensuring risks are minimized.

Feb 2018

What is the Cost of Poor Quality in Pharma?

By |2019-02-27T12:06:30+00:00February 20, 2018|Blog, Infographic, Library|Comments Off on What is the Cost of Poor Quality in Pharma?

Quality is a business decision. Everyone instinctively knows that poor quality doesn't come cheap, however until now no attempt was made to calculate the real difference between good and poor quality in clinical trials. Most of the issues that impact cost and expenses are lurking just below the tip of the iceberg.

Feb 2018

Adaptive Monitoring: The First Implementation Steps in Real-Life

By |2018-03-07T12:56:48+00:00February 13, 2018|Blog, Case Study|1 Comment

It is widely broadcasted that pharma companies will have to accelerate adoption of adaptive clinical trial designs to reduce study timelines and costs while increasing success rates. Risk-based Monitoring “Real RBM” integrates the Adaptive Monitoring (AM) process, which addresses all aspects of Quality Risk Management.

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