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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 »
By Kristin Brooks
Published March 6, 2014
Aims to improve efficiencies in data and work flow with reduced operational expenses 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 »
By S. Harachand, Contributing Editor
Published January 24, 2014
Clinical research continues to remain at the top of the news, courtesy of the Supreme Court of India. Through a series of judgments delivered on an ongoing litigation, the apex judiciary has directed the drug regulatory body to get its act together t… Read More »
Sharp Clinical Services
By John Phillips, Director, Sales
Sharp Clinical Services serves the Americas, Europe and the rest of the world with Formulation Development and Manufacturing, Analytical and Research Services, Stability Studies, Clinical Manufacturing, Over-Encapsulation and Placebo Manufacture, Cli… Read More »
By S. Harachand, Contributing Editor
Published June 5, 2013
India has rolled out a series of measures to streamline the country’s clinical research industry in recent years. Regulatory activity reached its peak recently with some bold steps, like compulsory registration of institutional ethical committe… Read More »
By Michael A. Martorelli, Contributing Editor
Published April 3, 2013
Seems like a good idea, right? Read More »
Published March 25, 2013
An independent committee of clinicians and statisticians whose task is to review the status of a clinical trial and make recommendations to the clinical research group concerning the trial’s continuation, modification and/or publication.… Read More »
Clinical Testing Technology
By Kevin Maskell, Merck Millipore
Published November 9, 2012
Applying flow cytometry to clinical trial samples Read More »
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