By Craig Morgan, Head of Marketing, goBalto
If you fail to plan, you are planning to fail. These words ring true when it comes to study startup, a notorious bottleneck in clinical trials. With research showing a continually stagnating timeframe for conducting clinical trials and a trend toward overhauling study performance, quality improvement is moving to center stage. With the availability of workflow-based study startup tools (Figure 1), proactive planning, process optimization and quality improvements—as measured by audit-readiness and the likelihood of passing regulatory audits—are within reach.
Proactive planning requires sponsors and contract research organizations (CROs) to identify what is needed up front to reduce risk – prior to study activation. Subsequent failure to do so resulting in problems not being identified until much later, after completed documents, artifacts and metadata have already been released to the trial master file (TMF), the repository of completed study documents. A better strategy is to employ processes that take an upfront approach to preventing or mitigating problems associated with document completion.