A Cohesive Solution to Manage Protocol Deviations in Clinical Trials During COVID-19

A Cohesive Solution to Manage Protocol Deviations in Clinical Trials During COVID-19

An American provider of biopharmaceutical services was struggling with COVID-19 related amendments and protocol deviations in clinical trials. A protocol deviation occurs when, without significant consequences, the activities on a study diverge from the Institutional Review Board-approved protocol. Such protocol deviations in clinical research are quite common. According to FDA, protocol-mandated visits, laboratory/diagnostic testing, and use of the investigational product are the key types of clinical trial protocol deviations and violations anticipated from COVID-19.

Hexaware helped the client with a holistic solution for managing and reporting protocol deviations in clinical trials related to COVID-19 and amendments happening during the pandemic, along with a centralized hub for clinical trial monitoring. Some of the highlights of the solution include a unified study view, prebuilt workflows aligning to study protocols, in-built reminders and approval process flows, a dashboard with meaningful metrics, and the ability to drill down on information from multiple systems for a given project and a lot more.

The solution led to excellence in clinical trial optimization, effort reduction, and performance improvement, delivering the following benefits:

  • Cohesive solution aids in more efficient operation across multiple enterprise levels
  • Significant effort reduction in managing protocol deviations
  • Minimized manual errors
  • Improved employee performance and efficiency

Fed up of COVID-19 related protocol deviations in clinical trials? Manage deviations and monitor trials on the go. Read more.

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