Building Risk Assessment and Mitigation Into Study Startup

The growing emphasis on risk-based management, beginning with study startup, is being fueled largely by regulatory  agencies, and by an intense desire of the industry to improve study execution. In keeping with the regulatory trend toward identifying and mitigating risk, forward thinking industry leaders have been trading in their Excel spreadsheets in favor of custom-built study startup applications that can automatically trigger workflows as a clinical trial  unfolds and provide data analytics. This transition away from Excel and toward technology offers a better risk profile through reporting of real-time data, and better communication with stakeholders.

This white paper describes why risk management and assessment are most effective when integrated into clinical trials from the beginning - from the study startup phase - rather than an afterthought addressed once a new product hits the market.