The New Health landscape requires bio pharmaceutical 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.
This article, appearing in the Drug Information Journal, examines the extraordinary opportunity for the bio pharmaceutical industry in using real-time data to drive better decisions faster. In the article, Paula Brown Stafford and Andrew Garrett identify the tremendous advantages afforded by access to real-time data during the course of a clinical trial, while recommending guidelines for mitigating associated risks. Topics discussed include:
- Technologies that have made access to real-time clinical trial data widely available
- Regulatory implications of reviewing real-time data throughout the life of clinical trials
- Clinical trial roles and the rationale for granting real-time data access
- Guidelines and controls for the use of real-time data throughout the course of clinical trials
- The role real-time data play in enhancing patient safety, strengthening quality and accelerating clinical trial timelines
- The tools that power real-time data capture and review