FDA Promotes Quality and Risk Management
April 1st 2013In recent documents and presentations, officials in the OSI in the CDER are highlighting the value of building quality into the design and operation of clinical trials to gain more efficient and effective monitoring and data verification systems.
Debate Intensifies Over Transparency of Trial Data
April 1st 2013A researcher from a top US institution has delivered strong criticism of Roche's promise to release full clinical study reports as part of its data transparency policy, signaling an escalation of the battle over publication of clinical trial results.