Here Is an Example Clinical Monitoring Approach Based on Regulatory Guidances and TransCelerate Recommendations
Every client is unique in how they run their clinical trials. We implemented the following process at a top 20 global pharmaceutical organization.
1. Draft study protocol
2. Conduct Risk Assessment and categorization
3. Identify and allocate study’s critical data
4. Build key risk indicators (KRI) and advanced analytics dashboards
5. Capture data and document observations from the dashboards
6. Review KRI/analytics outputs and flag issues
7. Review with study team potential issues
8. Mitigate issues by functional follow-ups
Our Experts Can Support Your Clinical Monitoring Change Initiatives At Any Stage
You want to improve your clinical monitoring processes. This means aligning processes with industry standards, complying with regulations, and gain cost-saving efficiencies. Our consultants can lead initiatives that will get SOPs, templates, and collateral ready.
Implement Advanced Tools
Advanced monitoring tools are a key component of eliminating manual processes. We have experience managing software vendors so that you can have a timely implementation of a new tool. We ensure a compliant and successful implementation.