FDA

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15 04, 2014

Is Risk Based Monitoring Appropriate for MENA?

By | 2016-10-12T14:35:11+00:00 April 15th, 2014|Categories: News|Tags: , , , , , |

A recent article in the Journal of Clinical Studies Volume 6, issue 2, 2014* discussed the applicability of new FDA and EMA recommendations for risk-based monitoring. Knowing that greater than 30 per cent of a clinical budget is allocated to cover monitoring costs and more than 50 per cent of that is spent on source document verification (SDV), risk-based monitoring allows companies to more effectively target and prioritize resources around [...]

24 01, 2013

Enrichment Strategies for Clinical Trials

By | 2016-10-12T14:35:11+00:00 January 24th, 2013|Categories: News|Tags: , , , , , , , , , |

Author: Steve Kates, Ph.D. A draft guidance has recently been issued (Dec 2012) entitled “Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products.” The document required more than 6 years to prepare and provides guidance to industry on enrichment strategies that can be used in clinical trials intended to support effectiveness and safety claims. This guidance outlines three enrichment strategies. 1. Strategies to decrease heterogeneity [...]