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
