Case Study 1
CASE STUDY 1 :
Small Size US-based eClinical Company
Problem Statement
- Multiple audit findings by a top 10 global pharma company due to QMS weaknesses.
- Needed a functional, globally compliant QMS within three months for an upcoming audit.
Our Approach
- Rapid Engagement: Started collaboration within 3 days of contract signing.
- Comprehensive Plan: Developed and implemented: QMS, Vendor Assessment, SDLC, CSV, Training Management, Risk Management, DRP, BCP.
- Deployment of Experts: Assigned experienced team members for quick execution.
- Phased Implementation: Completed critical QMS elements in Phase 1 within 3 months.
Success Story
- Passed the next client audit successfully.
- 7 successful client audits over the next 10 months.
- Clients succeeding to secured multiple project awards.
- Initial 4-month contract extended; now entering the 2nd year with expanded services.