Current Edition

Clinical Trials in Children – legal and  Ethical aspects
Regulatory V5 I4

Clinical Trials in Children – legal and Ethical aspects

The issue of clinical trials in children always causes a clash of opinions in the ethical and legal dimensions. Igor Svitlyk and lana Sinichkina at arzinger’s discuss...
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Pre-Screening: an Important First Step
Regulatory V5 I4

Pre-Screening: an Important First Step

Recruitment of patients in any clinical trial remains a critical bottleneck in the quest to accelerate the development of new treatments. In this article Sameer Parek...
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Cardiovascular Therapeutics Watch Column
Volume 5 Issue 4

Cardiovascular Therapeutics Watch Column

In this new regular Watch Column, Dr J. Rick Turner at Quintiles will be highlighting ‘hot topics’ in the development and therapeutic use of lifestyle modifications,...
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New Draft guidances Clarify Provisions for Expanded access to Investigational Drugs
Volume 5 Issue 4

New Draft guidances Clarify Provisions for Expanded access to Investigational Drugs

Two new draft industry guidances by the US Food and Drug Administration (FDA) clarify regulations enacted in 2009 for expanded access to investigational new drugs and...
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Cardiovascular Safety Watch Column
Volume 5 Issue 4

Cardiovascular Safety Watch Column

Cardiovascular Safety Watch Column This column focuses on a recent paper from the Cardiac Safety Research Consortium (CSRC) entitled “Cardiac Imaging Approaches to Ev...
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