Applied Clinical Trials-04-01-2013

Applied Clinical Trials

FDA Promotes Quality and Risk Management

April 01, 2013

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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.

Personalized Medicine

April 01, 2013

CROs, Service Providers, & Sponsors: An Evolving Relationship

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How partnering can speed companion diagnostic development.

Collaboration Planning

April 01, 2013

CROs, Service Providers, & Sponsors: An Evolving Relationship

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Sponsor-driven, CRO/recruitment provider collaborations propel cost-efficient study completion.

Safety Reporting From Clinical Trials—What Regulators Expect

April 01, 2013

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Monitoring patient safety is an integral and critical part of the clinical trial process.

Groundbreaking Strategic Partnerships

April 01, 2013

CROs, Service Providers, & Sponsors: An Evolving Relationship

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How Covance has achieved successful outsourcing relationships with pharmaceutical sponsors.

Debate Intensifies Over Transparency of Trial Data

April 01, 2013

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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.

CROs, Service Providers, and Sponsors: an Evolving Relationship

April 01, 2013

Issue PDF

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Applied Clinical Trials Digital Edition April 2013

April 01, 2013

Issue PDF

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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 Biospecimen Storage