In 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.
A 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.
CRO/Sponsor: Strategic Partnerships in Trial Outsourcing
Trial Design: The Future of Clinical Monitoring
Project Management: Negotiating Effective Agreements and Budgets
Also in this issue:
Trial Debate in European Parliament
Redefining Key Roles