Final

Services

Services

Regulatory Services

Competent Autorities Submission
Ethics Committee Submission
As per current regulations and guidelines

Our Services

Clinical Operations and Monitoring Services
- Site identification (KOL network)
- Feasibility
- Site qualification and initiation
- Regulatory document preparation and collection in line with international and local requirements
- Budget and contract negotiation

Clinical Operations and Monitoring Services
- Site recruitment strategy
- Site personnel training
- Interim site monitoring
- Accountability investigational material(s)
- Study closure

Quality Assurance / Quality Control
- SOP writing
- Accompanied Visits: Monitor and Site
- Audit / Inspection readiness
- Audit / Inspection support

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