Responsibilities Within a RBM Plan
Risk Indicators and Thresholds
Technology Guidance
Data Integrity
Metrics
Pace of Adoption
Pace of Adoption
While this is a year of critical inflection and important evolution for the biopharma companies leading the charge on risk-based monitoring, it will be several more years until RBM is considered “business as usual” for other organizations. If the industry is to see a widespread uptake in Centralized monitoring, the following areas will likely need action and change:
- Advanced tools and technology to catch up with the needs of companies
- Budget to purchase the new tools and technology, as well as to provide for the installation timelines
- Training for internal auditors and agency inspectors