Case study
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 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
The Results
- Successful design and implementation of operating models.
- Consistent global processes, procedures, and validated tools.
- Aligned with regulatory requirements and industry.
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