FDA

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.

Nov 2018

MCC – Clinical Trial Risk and Performance Management Summit

By |2018-10-22T09:06:57+00:00November 14, 2018|Comments Off on MCC – Clinical Trial Risk and Performance Management Summit

The Clinical Trial Risk and Performance Management Summit is interactive. You’ll roll up your sleeves with speakers and fellow attendees as you tackle case studies that will bring clarity to the metrics process — and provide you with the answers you need. Don't miss (Day 1): [...]

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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