Monthly Archives: March 2018

Mar 2018

Adaptive Monitoring: Anticipating The Human Factor

By |2018-03-21T19:31:12+00:00March 21, 2018|Blog, Case Study|0 Comments

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|0 Comments

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

Blockchain in Clinical Trials – The Ultimate Data Notary

By |2018-03-14T14:00:11+00:00March 14, 2018|News, White Paper|0 Comments

Blockchain technology is the biggest achievement in cryptography of the past decade. Source Data Verification (SDV), which consumes about 20–30% of the clinical trial budget nowadays, will become redundant when blockchain technology disrupts the pharma industry.

Mar 2018

Adaptive Monitoring: Beyond Data Trends and Timely Performance

By |2018-06-03T14:21:15+00:00March 7, 2018|Blog, Case Study|0 Comments

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.

Mar 2018

A Simple 5-step Plan to Improve Quality and Efficiency in Clinical Trials

By |2018-03-16T12:10:26+00:00March 2, 2018|News|0 Comments

Last February 28th, the FDA finalized the E6 (R2) version of the addendum to the International Council for Harmonisation's (ICH) good clinical practice (GCP) guideline. What to do now? Don’t panic, we’ve put together a simple 5-step plan to help you initiate the most urgent process adaptations.

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