E-Book | March 6, 2018

The Ultimate Starter Kit For Risk-Based Monitoring

Source: Medidata Solutions
The Ultimate Starter Kit For Risk-Based Monitoring

Clinical trials have evolved substantially since ICH adopted its original E6 Good Clinical Practice (GCP) guidelines in 1996. Trials have become more complex, clinical development is now a global operation and technological advancements are changing the ways sponsors want to conduct trials. In November 2016, ICH released its amended GCP guidelines in an effort to modernize the life science industry’s approach towards these practices. The E6 amendment means to encourage sponsors to implement innovative approaches to their clinical development programs, rather than focus on trial processes that impede progress.

In an increasingly digital era, as the business of clinical trials evolves into a more complex, cloud-based realm, placing a high premium on monitoring is most crucial. ICH even specifically called out the industry’s misguided focus on the “completeness and accuracy of every piece of data at the expense of critical aspects (e.g. carefully managing risks to the integrity of key outcome data). The paradigm has shifted, and trial leaders are asking, “How would a solid risk assessment plan help define endpoints, promote safety, and enrich overall trial quality?” “How does Centralized Monitoring enable  more meaningful conversations between CRAs and sites?” “How are predictive analytics streamlining trial workflow?”