CRO/SMOs

A shared global system for clinical research will facilitate many of the core processes intrinsic to CROs and SMOs alike:

• Reducing key operations and process costs of conducting trials for mutual benefit of clients and CROs
• Partnering with clients to innovate, including financially, by piloting alternative models on specific research programs and projects
• Increasing liability protection (legal, regulatory, and malpractice)
• Improving “site qualification” and site monitoring processes, including more robust informatics; ‘mapping’ to facilities and abilities of individual sites, given range of types of sites
• Reducing turnover of sites, by enhancing sustainability and professionalism
• Identifying more rapidly ‘at risk’ sites and need for intervention – whether in the course of the trial or under regulatory scrutiny
• Expanding available, qualified sites, especially in developing and re-developing world, including developing and accessing sites for under-represented/under-utilized patients
• Demonstrating to primary clients commitment to reduce speed-to-market and increasing patent protection
• Re-establishing public credibility/trust, especially by: addressing safety, regulatory, operational and performance challenges; and meeting corporate social responsibility (CSR) obligations, legislated or advocated