Applied Clinical Trials Digital Edition - October 2011
REGULATORY : Document Management Practices CARDIAC SAFETY : Safety Testing Has Evolved Also in this issue : PDUFA Legislation Expansion, EU Pharmacovigilance, Aggregate Data, Sunshine Act
Here Comes the Sun(shine Act)
Drug, biological supply, and medical device manufacturers must track all payments of over $10.
Cardiac Safety in Clinical Trials
Testing cardiac safety has developed into more than measuring a simple ECG test.
Business and News Update October 2011
Industry news focusing on the people and organizations who work in the clinical trials profession.
Debate Grows Over Comparative Efficacy Trials
UK officials stress importance of evaluating benefits of new therapies before approval.
The Power and Pitfalls of Aggregate Data
Public to private switch gives CROs better chance to "fix" and transform themselves.
Document Management
Five key steps for e-submission ready documents to avoid pre-submission rework.
Technology Helps Trim Reimbursement Times
New ClinCard system helps deliver payments in a faster and more efficient manner.
FDA, Sponsors Gear Up for User-Fee Action
Multiple regulatory and reimbursement proposals are slated to expand legislation to renew PDUFA.
Staying Vigilant on EU Pharmacovigilance
EU's new rules will be influenced by more than just those primarily responsible for pharmaceuticals.
Sponsors Show a Preference for Large CROs
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.
Oncology Drug Development
Cornerstone Pharmaceuticals' CEO Robert Shorr discusses oncology drug development challenges.
