Study Startup: The Last Major Frontier in Automating Clinical Operations
Crossing the chasm and completing the eClinical stack
Sponsors and contract research organizations (CROs) face intense pressure to speed clinical trials while boosting operational efficiency, but complex protocols, globalization, and paper-based methods have long stymied these efforts. The industry has stepped up with various cloud-based solutions such as clinical trial management systems (CTMS), electronic data capture (EDC), and the electronic trial master file (eTMF)—all quantum leaps—yet lengthy cycle times, lasting nearly seven years, are still commonplace. A key reason is that they do not address the one part of a study's lifecycle that strongly impacts the overall timeline of clinical trial conduct—study startup (SSU).
As more stakeholders acknowledge that better SSU processes are essential for shorter clinical trial timelines, SSU has become the last major frontier in clinical trial automation, the final holdout where spreadsheet methodology still looms large, and where innovation is making a resounding difference.
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