Clinical Monitoring Change Management

Key Challenges

  • Translate regulatory guidances without a consistent industry standard
  • Global alignment within a risk-averse organizational culture requiring significant change management
  • Lack of understanding of the tool because the process is new

Treximo Solution

We supported the implementation of a customized solution at a top 25 global pharmaceutical organization. Here is an example process:

  • Draft Study Protocol
  • Conduct Risk Assessment and Categorization
  • Identify and Allocate Study’s Critical Data
  • Build key risk indicators (KRI) and advanced analytics dashboards
  • Capture data and document observations from the dashboards
  • Review KRI/analytics outputs and flag issues
  • Capture data and document observations from the dashboards
  • Review KRI/analytics outputs and flag issues

Outcome

  • Successful design and implementation of operating models.
  • Consistent global processes, procedures, and validated tools.
  • Aligned with regulatory requirements and industry.