Year Before Europe’s New Clinical Trials Regulation Take Effect, Pharma Companies Must Prepare For A Tough Compliance Challenge


Next year about this time, the European Union will implement a new clinical trial regulation (EU CTR) meant to help pharmaceutical companies by offering clear and consistent rules for conducting clinical trials. The new regulation, EU CTR 536/2014, adopted last year and scheduled to take effect in May 2016 is intended to simplify a previous set of requirements governing clinical trials.
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Six Steps to Successful Sample Management


Effective sample management is critical to the overall success of a clinical trial, however it is often one of the most overlooked aspects of a clinical research project. The loss of data due to damaged samples or inaccurate documentation can cause a clinical trial to be repeated, or can prevent valuable therapies or devices from ever coming to market.
 
However, by putting some time in up front, many of these challenges can be avoided. Below are six smart ways pharmaceutical companies can avoid these common pitfalls that plague the clinical research industry.
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Pharmaceutical Companies and Compliance – The Many Levels of Enforcement


Compliance and quality go hand in hand. You can’t ignore one and expect the other. Pharmaceutical companies take compliance very seriously; it would be unreasonable to question whether or not they do. However, because compliance is a broadly encompassing term that in isolation is ambiguous, a better question to ask is, “Which aspects of compliance are taken seriously by sponsors and which are not?”
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