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Oct 2021

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

By |2021-10-19T07:04:49+00:00October 17, 2021|Blog, Free Infographics|0 Comments

The final version of the ICH E8(R1) guidance discourages the old-school "one size fits all" approach. Instead, risk-based quality management concepts such as QbD and CtQ factors predominate these modern-day considerations which encourage the biopharma industry to go beyond the traditional checklists. We've visualized the final 2021 guidance, "General Considerations for Clinical Studies," for you.

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...

Mar 2019

Your Practical Guide to Understanding Clinical KRIs

By |2019-03-20T10:55:19+00:00March 12, 2019|Free Infographics, News|0 Comments

Our key risk indicator infographic will give you a foundational understanding of KRIs, provide valuable examples of KRIs, and guide you towards getting started with your risk-based monitoring (RBM) program.

Jan 2019

Quality Tolerance Limits versus Key Risk Indicators, The Difference

By |2020-02-05T07:40:21+00:00January 18, 2019|Blog, Free Infographics|1 Comment

To clear up confusion surrounding the interpretation and use of QTLs and KRIs, we have created an easy to understand infographic for all clinical research experts involved in quality control.

Feb 2018

What is the Cost of Poor Quality in Pharma?

By |2020-09-23T09:07:14+00:00February 20, 2018|Blog, Free Infographics|0 Comments

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.

Jul 2016

FDA RBM Guidance MindMap

By |2019-03-12T12:28:18+00:00July 27, 2016|Blog, Free Infographics|0 Comments

Which elements must a Risk-based Monitoring (RBM) plan must contain? What are the sponsor responsibilities regarding clinical monitoring? What kind of monitoring methods does the FDA suggest? To answer these questions, please, explore the MindMap of the "Guidance for Industry. Oversight of clinical Investigations - A [...]

Sep 2015

ICH GCP Addendum Mind Map

By |2019-03-12T12:30:06+00:00September 10, 2015|Blog, Free Infographics|1 Comment

The pharma world is expecting a new regulatory "earthquake". GCP additions. The upcoming GCP addendum E6 (R2) by many experts is named already as "game changing". Clinical trial design, conducting, oversight, recording and much more is added now to GCP.   Let [...]

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