UAT/Validation

Constraints on Deployment of Software Upgrades

Sponsor companies face the ongoing business challenge of getting new products to market safely. Given the complexity of multi-site, global clinical trials, it's not surprising they often postpone upgrading software applications, such as reporting tools. At the same time, however, they know that the additional functionality and performance improvements help expedite reporting and data analysis across functional areas. Compounding this quandary is the shortage of specialized in-house personnel who embody three disciplines necessary to the timely execution of software upgrades: technology expertise, domain expertise to understand the needs of all end-users and knowledge of current FDA guidelines.

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