Sponsors

A global clinical research system will address the long-standing failure of the industry to invest in, and reap the rewards of, a sustainable community of high-performing, high-quality, inter-operable clinical research sites by:

• Expanding the number of available, qualified sites, especially in developing nations, including sites for under-represented/under-utilized patients
• Improving “site qualification” and site monitoring processes, including more robust informatics; ‘mapping’ facilities and abilities of individual sites
• Reducing turnover of sites, by enhancing sustainability
• Identifying more rapidly ‘at risk’ sites and need for intervention – whether in the course of the trial or under regulatory scrutiny
• Reducing the costs of critical operations and process through standardization and interoperability
• Improve the quality of performance and data
• Increasing liability protection (legal, regulatory, and malpractice)
• Piloting alternative models for specific research programs and projects as the existing clinical trials paradigm evolves
• Reducing time-to-market and increasing patent exclusivity period
• Re-establishing public credibility/trust, especially by: addressing safety, regulatory, operational and performance challenges; and meeting corporate social responsibility (CSR) obligations, legislated or advocated