As trials have grown increasingly complex, often involving both on-site and remote activities, ensuring data quality takes on a whole new dimension. Safeguarding patient wellbeing, achieving expected trial outcomes, and meeting compliance requirements are paramount concerns. At Allucent, we offer our clients centralized monitoring services to oversee the conduct of their study, and address risks while the study is ongoing.
The first step is to use a risk assessment to determine the monitoring strategy. Approaches can vary depending on the objectives and scope of your study. Regular listing reviews identify time-critical patient-level issues requiring immediate follow-up. Review of study metrics determines issues requiring resources to be directed where they are most effective.
For larger studies, data imported from multiple sources into a central statistical monitoring platform facilitates the characterization of risk in a structured way through use of QTLs and KRIs. Additionally, unsupervised surveillance is used to identify atypical data that requires further investigation. No matter what strategy is most appropriate for your study, we take a risk-based approach to ensure high standards of data collection and to support you in achieving your trial goals.