Spotlight on Quality in Study Startup

Spotlight on Quality in Study Startup
Emphasis on quality is everywhere, but in particular, the study startup portion of clinical trials is a particular hotspot, as it is pivotal to improving study conduct overall. Specifically, as a complex multi-step process, it is renowned for bottlenecks that cause a seemingly intractable eight month timeframe for moving from pre-visit through site initiation. Improving this bleak performance is important because study startup generates 40% of the artifacts that eventually flow into the trial master file (TMF).

With unrelenting pressures to rein in budgets and cycle times, stakeholders are turning to quality as a solution, starting with building it into study startup and bringing change to the entrenched silos that stall clinical trial operations. Fortunately, workflow-based study startup tools are available which facilitate a proactive planning process for stakeholders seeking to improve quality by determining which documents are needed and in which format. This forward-thinking approach supports audit-readiness and greater likelihood of passing regulatory audits.

Download our white paper to learn about how automated workflows encourage upfront planning and downstream improvements in the eTMF.

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