Abstract
The new health landscape requires biopharmaceutical companies to conduct smarter clinical trials and produce better outcomes faster. Electronic data capture and electronic data review tools enable drug developers to review data shortly after it is captured, creating opportunities for improving the process and outcomes of clinical trials, and proactively managing quality, patient safety, and risk. We examine the extraordinary opportunity for the biopharmaceutical industry to use real-time data to drive better decisions faster. We identify the advantages of access to real-time data during a clinical trial, while recommending guidelines for mitigating associated risks. Topics discussed include the following:
Technologies that make access to real-time clinical trial data widely available Regulatory implications of reviewing real-time data throughout clinical trials Clinical trial roles and the rationale for granting real-time data access Guidelines and controls for use of real-time data during clinical trials How real-time data enhance patient safety, strengthen quality, and accelerate timelines
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