Eliminating The Guesswork From Critical Decision Making

When data is entered incorrectly, human error is the primary reason. Unfortunately, this is sometimes discovered not when critical decisions are being made, but when reconciliation and cleaning of the data are taking place later in the clinical trial/ process. If a patient appears to have met inclusion criteria based on faulty data, this potentially can lead to a serious scenario and protocol violations that must be reported. More importantly, it can have severe consequences for patients.

In a recent case study involving the sponsor of a Diabetic Foot Ulcer trial, the team emphasized that it would need a solution for a single, unified central database to lower the risk of human error. To specify the study’s specific needs, four key decision points were outlined that required a broad range of data, including pre-screening, screening, randomization and conduct, and the extension phase.

By leveraging Medidata's unified platform of Rave RTSM and Rave EDC, learn how the sponsor overcame the logistical complexities of patient randomization, streamlining, and condensing processes. The integrated solution also facilitated a seamless patient journey and enhanced the sponsor experience, ultimately ensuring the desired outcomes of a successful trial.