Market Research Report: Risk-Based Monitoring: Improving The Clinical Trial Site Experience

Source: ISR Reports

Market Research Report: Risk-Based Monitoring: Improving The Clinical Trial Site Experience

Advances in technology have allowed risk-based monitoring to become more frequently implemented in clinical trials. This market research report explores the impact technology has had on the implementation of RBM on clinical trial operations as experienced by site personnel.

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Both sponsors and CROs can use this report to get high-level perspectives on the clinical trial experience through the eyes of the site staff running the operation. This not only provides insight into what drives their performance, but also what challenges they encounter on a daily basis that could potentially be addressed with the implementation of new risk-based monitoring technologies. The report also provides insight into how sites view the role of the CRA, issues they encounter in their CRA interactions, and what their typical working relationship with CRAs entails. Those surveyed also provided information on the following:

  • How a risk-based approach to monitoring can affect daily operations at clinical sites.
  • Site personnel’s baseline level of knowledge and reactions to RBM to help sponsors/CROs plan useful conversations with trial staff regarding RBM implementation.
  • Best practices for RBM use as relayed by site staff, including best practices for communication and training. Advice to sites and sponsors/CROs that are implementing a risk-based approach to monitoring.

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