Negotiating Effective Clinical Trial Agreements and Study Budgets with Research Sites
Negotiating skills can be applied to clinical trial agreements, budgets, and more for effective and fair contracts.
FDA Promotes Quality and Risk Management
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.
How partnering can speed companion diagnostic development.
Sponsor-driven, CRO/recruitment provider collaborations propel cost-efficient study completion.
Standardization in Biospecimen Storage and Research
There are scarce or illdefined national and international regulations on quality control and standardization of biorepositories.
Business and People April 2013
Industry news focusing on the people and organizations who work in the clinical trials profession.
Synchronizing Study Start Up Across Regions Leads to Improved Global Trial Performance
Act Insert Cover
The Best-Laid Plans...
The clinical trial debate in the European Parliament is bogged down by rival schools of thought.
Some Things Work Better as Partnerships
Partnership agreements for CROs and eClinical technology providers can be as beneficial as sponsor/CRO partnerships.
Safety Reporting From Clinical Trials—What Regulators Expect
Monitoring patient safety is an integral and critical part of the clinical trial process.
Groundbreaking Strategic Partnerships
How Covance has achieved successful outsourcing relationships with pharmaceutical sponsors.
Debate Intensifies Over Transparency of Trial Data
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.
What Does the Future Hold for Clinical Monitoring?
Current commercial forces are working to accelerate the adoption of adaptive monitoring designs.
Shortening Clinical Trial Start-Up Times and Increasing Enrollment Using Historical Performance Benchmarks
Linking Leaders: Beyond the Boardroom
A view on redefining key roles across the evolving clinical development landscape.
CROs, Service Providers, and Sponsors: an Evolving Relationship
Applied Clinical Trials Digital Edition April 2013
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
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