Don't Settle for Less. Redefining the Core and Scope of Study Startup
Beyond site activation...How purpose-built technology is expanding the definition of study startup
There are more than 281,000 clinical trials currently underway across the globe, all having tackled the daunting task of study startup. It is surprising that this critical part of clinical trials lacks an industry-wide definition, especially since it is key to optimizing operational efficiencies and compressing timelines.
Study startup, as described by Lamberti et al, includes country selection, pre-study visits, site selection and initiation, regulatory document submission, contract and budget execution, and enrolling the first patient. Each of these steps has multiple components, all of which must be tracked to reduce the likelihood of bottlenecks.
This white paper focuses on defining and expanding the definition of study startup, an element of clinical trials that is gaining attention because it offers the greatest opportunity to improve quality while compressing clinical trial timelines. The importance of well-managed study startup is seen in data from various research initiatives. For example, a survey by the Tufts Center for the Study of Drug Development (CSDD) found that issues related to the budgeting and contracting portion of study startup are the major reason for site activation failure. This was true for 50.5% of sponsors and 54.3% of contract research organizations (CROs). Fortunately, with the advent of purpose-built technology offering broad functionality, real changes are happening.
Download our white paper "Don't Settle for Less. Redefining the Core and Scope of Study Startup" to learn how by technology designed to improve study startup is at the forefront of expanding this niche through initiatives that drill down to the granular level, which helps identify potential bottlenecks and other factors that could derail studies.
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