EMA

Apr 2019

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

By |2019-04-17T08:59:40+00:00April 15, 2019|Blog|Comments Off on FDA Q&A Guidance Document: The RBM Process-Technology Fit

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

Feb 2019

3 Critical Aspects of Clinical Trial Conduct that Affect the Totality of Evidence

By |2019-02-27T20:13:40+00:00February 27, 2019|Blog|Comments Off on 3 Critical Aspects of Clinical Trial Conduct that Affect the Totality of Evidence

Even without it being mandated, health authorities typically expect pharma and biotech companies to conduct two well-controlled Phase 3 trials demonstrating efficacy and safety. Still today this principle ensues discussions regarding the quantity and quality of the evidence needed to establish effectiveness.

Dec 2017

Newsletter: Start 2018 with an easier way to manage your clinical risks

By |2017-12-13T13:58:18+00:00December 11, 2017|News|Comments Off on Newsletter: Start 2018 with an easier way to manage your clinical risks

100% SDV...seriously, who DOES this? Start 2018 with an easier way to manage your clinical risks.

Dec 2014

Duality of Risk-based Monitoring Definition: EMA vs FDA

By |2019-03-21T12:16:18+00:00December 9, 2014|White Paper|Comments Off on Duality of Risk-based Monitoring Definition: EMA vs FDA

In October 2014 at the Risk-based Monitoring conference in Copenhagen the Senior Director QA Operations of Janssen, Jan Van Parijs said: "Industry is historically heavily regulated, so as an industry we are kind of used to the fact that the authorities provide a set [...]

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