Risk-Based Monitoring Market Assessment (2015)

Report Overview

The 2015 edition of ISR’s Risk-based Monitoring Market Assessment captures a view of those in the market who have or who plan to adopt RBM in addition to or as an alternative to the traditional 100% Source Data Verification (SDV) monitoring model.  Within this report, the reader will learn if and how the benefits of RBM have out-weighted its risks, how RBM has changed staffing models, the experience of firms that have adopted RBM, and the expectations of firms planning to adopt the approach.

What you will learn:

• The benefits of adopting RBM compared to the risks
• How RBM changes staffing models and operating procedures
• The overall experience of firms that have adopted RBM
• Which phases and therapeutic areas are currently or planning to use RBM in clinical trials
• The expectations of firms planning to adopt the approach
• Which companies are recognized as leaders in RBM adoption and use
• Main barriers that prevent companies from adopting risk-based monitoring

How you can use this report:

• Plan for RBM adoption based on lessons learned from firms that have already adopted RBM
• Make strategic decisions based on study site and drug supply chain impact
• Plan for potential cost impact with RBM adoption
• Compare in-house vs. outsourced tools for RBM trials