March 17, 2004 | The value of electronic data capture (EDC) technology has too often been stated in terms of reduced costs of query resolution, or less travel, or shortened time to data-lock. Many EDC vendors have even claimed "$1-million-per-day" savings in recovered revenues. These vendors, desperate to reach critical market share, overpromised on the possibilities of EDC.
Furthermore, many attempts to quantify return on investment have neglected to measure a baseline of costs, partly because this information is so difficult to obtain from clinical operations. Not surprisingly, biopharma companies considering EDC adoption then question whether the purported savings are achievable — and as a result they delay adoption accordingly.
While some of these savings may indeed be achievable, biopharmas should not overlook what is arguably EDC's most significant value: data access. Data entered into an EDC system become real-time data, and may then be reviewed and assessed on a daily basis, rather than months later. Faster, more accurate assessments of patient data can lead to earlier course corrections and rescue a trial from the path to failure.
In addition, the metadata (i.e., who entered the data, when, and in response to what) can yield valuable information about the process of clinical trial data collection and management, providing insights into improving the process and benchmarking for quality and best-practice development. Companies adopting EDC with best practices are building systems to leverage these data that can be obtained only with EDC systems.
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