Jul 2021

How to Build Critical to Quality Trees for Clinical Research

By |2021-08-02T10:19:22+00:00July 29, 2021|Blog|0 Comments

Building Critical to Quality Trees helps you to translate critical study needs and quality drivers into measurable outcomes and processes. Initially, this Lean Six Sigma approach serves as a business tool based on customer needs. Still, it is a helpful method of implementing Quality by Design in clinical research.

Jun 2021

Adverse Event Reporting as an Example of the Risk Assessment Process

By |2021-08-02T15:33:48+00:00June 29, 2021|Blog|0 Comments

Do you find the prospect of Risk Analysis and Risk-Based Quality Management (RBQM) to be daunting? Then bear with us. We shall help you simplify and demystify the process by using an example to illustrate the key steps to consider.

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.

May 2019

Centralized Monitoring: a Greater Advantage to a Broader Range of Trials

By |2019-07-19T14:05:06+00:00May 2, 2019|Blog, Free Infographics|0 Comments

Regulatory bodies are unanimous, today's clinical research needs Centralized Monitoring. We summarized Centralized Monitoring the infographic way, download your free copy here...

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