RESQ and Centralized Monitoring

Due to technology advances such as advanced Electronic Data Capture (EDC) systems, Centralized Monitoring (total or hybrid approach) is emerging as a viable option for clinical trial operations and has been endorsed by FDA as an approach to be used when developing and employing risk-based monitoring approaches.

However, FDA acknowledges that no single approach to monitoring is appropriate or necessary for every clinical trial and strongly encourages Sponsors to tailor monitoring plans to the needs of the specific trial. The FDA also claims that for the foreseeable future, Sponsors will need to use some amount of on-site monitoring; moreover, the complete absence of on-site monitoring will be unusual.

Many CROs and FSPs are extolling the virtues of remote, centralized monitoring procedures as a panacea. Others have not embraced the approach at all yet. And still, others offer a hybrid approach. While Sponsors are sorting through these various approaches, it is important for them to note that FDA acknowledges that there are limited empirical data to support the relative utility of the various monitoring methods.

In summary: RESQ understands and is prepared and flexible to utilize on-site, centralized, and hybrid monitoring approaches. We have our eye on the ball. We never forget that the primary focus of monitoring is to validate the processes that are critical to protecting human subjects, maintaining protocol integrity and study data, and for ensuring compliance with applicable regulations. We will work with Sponsors to put in place a monitoring approach that best accomplishes these goals to ensure project success.