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Clinical Monitoring Change Management

The Challenge 

  • 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.

The Results 

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

The Solution 

Planet Pharma staffed talent to support the implementation of a customized solution at a Top 25 Global Pharmaceutical Organization.

Here is an example of their process:

  • Draft study protocol
  • Conduct risk assessment and categorization
  • Identify and allocate 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