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