Applied Clinical Trials-10-01-2011

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

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

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

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

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

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

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

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

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

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

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.

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