May 2021

7 Most Important QTLs for Clinical Trials

By |2021-06-29T11:24:22+00:00May 5, 2021|Blog|0 Comments

Within the bounds of risk-based quality management, the utilization of predefined Quality Tolerance Limits (QTLs) is a way to control quality and risk in clinical trials. QTLs identify systematic risks to patients and data integrity at the study level. We've listed the 7 most commonly used QTLs that are applicable to most trials.

Dec 2019

Quality by Design | ICH E8(R1) General Considerations for Clinical Studies

By |2020-01-15T09:38:50+00:00December 18, 2019|Blog, Free Infographics|0 Comments

ICH E8(R1) discourages the old-school “one size fits all” approach, instead the modern day guidance encourages bio-pharma to go beyond the traditional checklists. We've visualized the 2019 guidance "General Considerations for Clinical Studies". Download our free infographic today to be ready for tomorrow.

Oct 2018

Data Integration – A Valid Concern or a Convenient Excuse?

By |2020-09-23T10:10:46+00:00October 11, 2018|Blog|0 Comments

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.

Upcoming Events

  1. CORE West by Halloran

    September 22 - September 24
  2. 25. Jahrestagung der GQMA

    September 23 - September 24

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