Over the last 10 years, clinical trials have changed substantially in response to increasing globalization and study complexity, along with new technological capabilities and industry guidelines,7. With these noticeable transformations, sponsors are increasingly revisiting their monitoring methods to uncover new efficiencies and develop more robust risk management processes that can enhance ongoing patient safety and data quality.
At the forefront of this movement is risk-based monitoring (RBM) – a broad term for a variety of clinical monitoring methods that combine people, process and technology, enabling project teams and Clinical Research Associates (CRAs) to focus on the most important risks in clinical trials.
A six-step systematic, proactive approach to your study can help transform risks into returns
Recently, the major regulatory agencies—FDA and EMA—have highlighted their concerns that current monitoring approaches are not only inefficient, but they also fail to support the overall integrity of the trial itself. In the light of recent regulatory guidances for risk-based monitoring (RBM), the industry is re-thinking the way clinical trials are conducted.
However, even before your study commences, the opportunity for RBM is present. By viewing your study as a holistic process—and by leveraging prior experiences and insights—you can more effectively manage risk while simultaneously optimizing quality. Continue reading