Applied Clinical Trials
October 01, 2011
Issue PDF
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REGULATORY : Document Management Practices CARDIAC SAFETY : Safety Testing Has Evolved Also in this issue : PDUFA Legislation Expansion, EU Pharmacovigilance, Aggregate Data, Sunshine Act
October 01, 2011
A Closing Thought
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Drug, biological supply, and medical device manufacturers must track all payments of over $10.
October 01, 2011
Feature Article
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Testing cardiac safety has developed into more than measuring a simple ECG test.
October 01, 2011
Business News
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Industry news focusing on the people and organizations who work in the clinical trials profession.
October 01, 2011
Global News
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UK officials stress importance of evaluating benefits of new therapies before approval.
October 01, 2011
Technology Viewpoint
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Public to private switch gives CROs better chance to "fix" and transform themselves.
October 01, 2011
Feature Article
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Five key steps for e-submission ready documents to avoid pre-submission rework.
October 01, 2011
News
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New ClinCard system helps deliver payments in a faster and more efficient manner.
October 01, 2011
View from Washington
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Multiple regulatory and reimbursement proposals are slated to expand legislation to renew PDUFA.
October 01, 2011
View from Brussels
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EU's new rules will be influenced by more than just those primarily responsible for pharmaceuticals.
October 01, 2011
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Industry Standard Research has recently published new research titled "Post-marketing Safety Market Dynamics," which deeply dives into the growth and decline of study conduct and outsourcing in the post-marketing safety arena.
October 01, 2011
News
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Cornerstone Pharmaceuticals' CEO Robert Shorr discusses oncology drug development challenges.