Applied Clinical Trials-10-01-2011

Issue PDF
Applied Clinical Trials

October 01, 2011

REGULATORY : Document Management Practices CARDIAC SAFETY : Safety Testing Has Evolved Also in this issue : PDUFA Legislation Expansion, EU Pharmacovigilance, Aggregate Data, Sunshine Act

Applied Clinical Trials
A Closing Thought

October 01, 2011

Drug, biological supply, and medical device manufacturers must track all payments of over $10.

Applied Clinical Trials
Feature Article

October 01, 2011

Testing cardiac safety has developed into more than measuring a simple ECG test.

Applied Clinical Trials
Business News

October 01, 2011

Industry news focusing on the people and organizations who work in the clinical trials profession.

Global News
Applied Clinical Trials

October 01, 2011

UK officials stress importance of evaluating benefits of new therapies before approval.

Applied Clinical Trials
Technology Viewpoint

October 01, 2011

Public to private switch gives CROs better chance to "fix" and transform themselves.

Applied Clinical Trials
Feature Article

October 01, 2011

Five key steps for e-submission ready documents to avoid pre-submission rework.

Applied Clinical Trials

New ClinCard system helps deliver payments in a faster and more efficient manner.

Applied Clinical Trials
View from Washington

October 01, 2011

Multiple regulatory and reimbursement proposals are slated to expand legislation to renew PDUFA.

Applied Clinical Trials
View from Brussels

October 01, 2011

EU's new rules will be influenced by more than just those primarily responsible for pharmaceuticals.

Applied Clinical Trials

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.

News
Applied Clinical Trials

October 01, 2011

Cornerstone Pharmaceuticals' CEO Robert Shorr discusses oncology drug development challenges.