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Drug Supply Shortages in Clinical Trials
By John Burns , BioClinica
Published November 13, 2014
Impacts on studies and how to avoid them. Read More »
Published October 20, 2014
“Direct to Patient” shipping adds flexibility for clinical trial participants Read More »
By S. Harachand, Contributing Editor
Published June 3, 2014
The government is scrutinizing the way that severe adverse effects are reported, and revisiting fnancial compensation requirements Read More »
New Rules on Medicinal Product Clinical Trials in Europe
By Genevieve Michaux, Hunton & Williams LLP
Published March 7, 2014
In April 2014, the European Parliament and European Council will officially adopt a new regulation on clinical trials of medicinal products (the Regulation). The Regulation is expected to take effect in May 2016 and will replace Directive 2001/20/EC,… Read More »
Clinical Trial Outsourcing Report
By Steven Aldrich, Kalorama Information
Published March 7, 2012
Where are the opportunities in the $36.6 billion market for outsourcing clinical trials? Read More »
Published February 27, 2012
Carefully designed investigations of the effects of investigational new drugs, medical treatments, or devices on a group of patients. There are typically three phases of clinical trials prior to the filing of an NDA, sometimes followed by ongoing, po… Read More »
Structured Design Methodologies In Clinical Research
By Frederic L. , Quintiles
Published September 5, 2013
Lessons learned from other industries can help biopharma improve its design practices Read More »
By Colleen Heisey, J.D., M.P.H., Hunton & Williams LLP
Published January 22, 2013
FDA revises draft guidance document to address industry comments Read More »
Published March 21, 2012
Bruno brings 18 years of clinical and regulatory expertise Read More »
By Adam Serody, VP, Global Business Development


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