Spotlight on Quality in Study Startup (SSU)
Automated workflows encourage upfront planning and downstream improvements in the eTMF
There is a dazzling array of quality initiatives within the clinical trials sector all looking to move the needle from paper-based methods or single point solutions to a more integrated, non-siloed approach to study conduct. These efforts, may be rooted, at least somewhat, in work started nearly 20 years when the Institute of Medicine published To Err is Human, a call-to-action to improve safety in our healthcare system by linking it to greater quality. That seminal work was followed by various reports recognizing the urgent need to transform the clinical trials enterprise by focusing more intently on quality, which leads us to today's sharp focus on this subject.
Emphasis on quality is everywhere, but in particular, the study startup (SSU) 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 SSU 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 SSU and bringing change to the entrenched siloes that stall clinical trial operations. The process starts by recognizing that many elements of clinical trial execution are rolled out during SSU, making proactive planning a priority. Without this critical step, study conduct can be delayed, siloed efforts continue, and documents eventually released to the TMF or eTMF may be missing or incomplete. Fortunately, workflow-based SSU 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.
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