CRO/Sponsor - Applied Clinical Trials

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Developments, news and strategies for drug development specific to phase I through Phase III global clinical trial management, execution, project management and outsourcing.
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Outsourcing's Evolution from Commodity to Partner
August 1, 2008
Can the historical industry and vendor service relationship change to one where both parties benefit?
How we Fail to Use CROs Effectively
August 1, 2008
Productive relationships with CROs require a well thought out strategy on the part of sponsors.
Balancing the Three-Legged Stool
August 1, 2008
REMS are new only in name. The basic concept has long been central to drug regulation.
Steps to Functional Service Provider Success
August 1, 2008
Outsourcing fundamentals for this pick-and-choose model so that both sponsors and service providers win.
Chartering a Data Safety Monitoring Board
July 1, 2008
Detailed charter defines the roles of the group and their relationships with other study team members—and it's available inside as a word document that you can download for use.

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Articles By Category
Drug Development
Research, development, Phase 0–IV
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Global Trials
Emerging markets, globalization, worldwide trials, outsourcing
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Project Management
Issues related to managing the clinical trial
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Business and People Update
Adventures in Web-Based EDC
August Global News
DIA Adds More History to Boston
Pharsight and CRI Worldwide Establish Alliance
Better Feasibility for Global Clinical Trials
August 8, 2007
Clinical Trials in Russia 1
June 13, 2007
Clinical Trials in Russia 2
June 12, 2007
Costing Methods for Clinical Trials: A Comparison of Activity Based Costing and Traditional Costing
May 31, 2007
7 Total Cost of Ownership Truths to Consider When Deploying an Enterprise Compliance Management System
May 31, 2007
Drugs@FDA Downloadable Data Files (updated)
Guidance for Industry
Guidance for Industry
Drug Shortages: Current Drug Shortages; Zanosar (Streptozocin) Injection
FDA updates the Information for Healthcare Professionals sheet for Tysabri (natalizumab)
Public Hearing for Over-the-Counter Cough and Cold Medications
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