The FDA has begun encouraging drug developers to take a risk-based approach and turn to new technology to help them monitor clinical trial work, according to Outsourcing-Pharma (Risk based centralised trial monitoring wanted by FDA) and Pharmalot (FDA urges remote monitoring of clinical trials).
In a new set of proposed guidelines, regulators encourage sponsors to monitor clinical trial quality without the need to visit sites as frequently. The FDA guidance also endorses transferring the responsibility of monitoring to a CRO.
We couldn’t agree more! Check out our latest client success story using the Just-in-Time Monitoring approach.
But, it’s important to select a CRO that aligns its processes with this methodology in mind. Improved technology adoption and clinical operations processes are now making it possible to redefine the role of clinical monitoring (within the context of trial operations), while at the same time decreasing costs and increasing clinical trial oversight. At Clinipace Worldwide, our Just-in-Time Monitoring methodology is ahead of the curve, already dramatically changing the way we interact with our trial sites.
Because the electronic clinical systems of a digital CRO enable real-time trial enrollment visibility and confer the ability to identify and resolve data discrepancies remotely, the need for site visits is reduced. Clinical research associates (CRAs) on a technology-amplified study do not have to travel as much as they did in the traditional model. By employing a just-in-time monitoring approach (enabled by the digital CRO model), CRAs can obtain the information they need and travel to the site only when justified based on pre-specified criteria such as accumulation of data, queries, or other triggers such as a serious adverse event or protocol deviation.
We’re pleased to see the FDA validating what we’ve been practicing for years, and look forward to seeing more overall success in the industry based on this innovative shift.