Section 3

Best Practices for Implementation

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

Section 4: Research Milestones

Member Research