Blog

Feb 2020

Healthy Volunteers – Phase 1 RACT Now Available

By |2020-02-17T08:17:26+00:00February 11, 2020|Blog, News|0 Comments

The need for a controlled research environment adds another risk dimension to the Phase 1 study design. The new Healthy Volunteers - Phase 1 RACT serves as a helpful source to ensure maximum subject safety and a reliable outcome.

Dec 2019

Challenges Associated with Clinical Research in Heart Failure

By |2020-02-11T12:57:00+00:00December 19, 2019|Blog|0 Comments

Heart Failure (HF) is a complex clinical syndrome. Our CSO, Dr Johann Proeve, explains the challenges associated with the conduct of clinical studies in the various heart failure stages.

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 for Clinical Experts|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.

Jul 2019

A Clinical Research Must-Have: Next Generation Predictive Analytics

By |2019-07-08T11:57:09+00:00July 8, 2019|Blog|0 Comments

Predictive Analytics is seen as the next generation methodology: “growing across most therapy areas in the coming years”. Pharma companies and CROs that embrace next generation analytics will position themselves for immeasurable competitive edge in the industry. 

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 for Clinical Experts|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...

Apr 2019

FDA Q&A Draft Guidance Document: The RBM Process-Technology Fit

By |2019-05-27T15:16:11+00:00April 15, 2019|Blog|0 Comments

Our expert team reviewed the March 2019 RBM Q&A draft guidance document and extended the FDA guidance with RBM solution specific insights and a MindMap to help you even further.

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