Correcting Legacy Problems Of Mid-Study Change With Fountayn

By Patrick Smith, Fountayn

Mid-study change is an ever-present risk within a clinical trial. According to a 2021 Impact Report by the Tufts Center for the Study of Drug Development (CSDD), drug developers reported an average of 4.1 planned and 3.7 unplanned mid-study changes per trial. Those companies also endured an average of between 25 and 40 days of downtime before resuming a trial following a mid-study change (depending on the company size).
Nearly one-third of the survey’s respondents considered database delays, lack of integrated eClinical suites, and solution costs as major pain points connected to mid-study change. However, the assumption that database migrations and their associated risks are an unavoidable cost of mid-study change is inaccurate. Significant elements of mid-study risk and cost can be eliminated by removing database migration from the remediation process.
Fountayn’s EDC solution is one of few (if not the only one) built from the ground up to cooperate across all the different areas where it has been or will be used — rather than an aggregation of disparate systems “Frankensteined” together following mergers or acquisitions. Understanding data migration to be a pain point for our clients, Fountayn considered the problem early in platform design. Not being limited by historic integrations grants us exceptional freedom in terms of user experience and utility. While implementing mid-study changes on the fly is not an especially complicated design feature conceptually, it likely is difficult to implement in legacy platforms far along in their development/deployment.