I just came across a recent story in Outsourcing Pharma about how risk based clinical trial monitoring could simplify trial data quality checking.
The story points to potential industry confusion over the FDA’s recent guidelines. The main theme of the quoted expert’s feedback is that certain aspects of clinical trials can be quality checked using only asegment of the trial data. Also, a main aspect of the risk-based monitoring approach – sponsors and CROs paying closer attention to “riskier” trials as opposed to a traditional approach to monitoring, which requires a more structured site visit schedule every x number of weeks, regardless of risk. Less risky sites may be visited less often, only when data deems it necessary.
This is the exact approach that drove our organization to implement a unique methodology called Just‐in‐Time Monitoring, which is dramatically changing the way we interact with our trial sites.
As a result, CRAs can view a variety of data elements remotely and immediately detect any outlying or troublesome data (such as an adverse effect). This improved level of visibility into the data means that small problems can be spotted early and don’t have the opportunity to develop into larger issues that might slow the study or endanger a patient.
Just‐in‐time monitoring increases efficiencies and reduces costs while making onsite visits more focused, more strategic and less disruptive to patient care. In fact, in a recent trial where Clinipace implemented this approach, the sponsor estimated a 30% savings in the cost of monitoring the trial — that’s more than $1M in operational costs. If you’d like to learn more, please download the Just-in-Time: Taking a New Approach to Monitoring whitepaper.
We’re currently working on a new whitepaper (available Q2 2013) in which we take a deep dive into mitigating the challenges of clinical trial monitoring through a technology-amplified approach. The accelerated number, pace, and globalization of clinical trials today has made trial management and monitoring far more complex and costly. Sponsors and CROs have been increasingly embracing EDC technologies and fully integrated clinical trial management systems to ensure quality and gain efficiencies. Given the significant investment in time, resources, and money spent on monitoring activities, trial sponsors must make sure their CROs are using the best, most efficient methods for study oversight and quality assurance.