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Best Practice Database
Quality, Compliance and Regulatory » Assuring Quality Programs
Single User: Authorizes use by the person who places the order or for whom the order was placed.
Sitewide: Authorizes use of the report for a geographic site. All people at site can view the report for a year and copies can be printed.
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Leading pharmaceutical companies seek to achieve and maintain world-class excellence in all aspects of pharmaceutical quality from research and development to manufacturing. In pursuit of this goal, savvy companies aggressively seek the necessary information, insights and advice to advance the entire quality organization.
This seven-page document gives an overview of the key findings, top three lessons learned and the top three challenges in managing R&D quality excellence as identified by eight leading pharmaceutical companies.
Top findings include:
1. Companies with a centralized structure for R&D quality enjoy considerable staffing efficiency when compared to other organizational structures.
2. Almost all executives indicated that R&D Quality is not adequately staffed.
3. All partners identified the responsibility for auditing quality at thousands of clinical trial sites with limited staff as a tremendous challenge.
This research originates from a Best Practices, LLC consulting project.