QUALITY & SECURITY COMMITMENT
Quality Management System (QMS)
- SOP-driven framework covering Clinical, Regulatory, Safety, Data, and Biostats
- Risk-based processes aligned with ICH-GCP, WHO, GAMP 5, and global standards
- Full QMS lifecycle support: SOP governance, CAPA handling, audit readiness, and document control
Data Quality Assurance
- Rigorous data checks from eCRF to database lock
- Metadata validation, audit trails, and access controls
- CDISC/CDASH compliance and 21 CFR Part 11 adherence
- Joint data reviews with Clinical and Biostats teams
Independent Quality Oversight
- QA-led compliance checks and internal audits
- Real-time dashboards and KPIs for early risk detection
- Ongoing training to embed a quality-first culture
- Full inspection readiness, including mock audits and regulatory support
Certifications
- QMS & ISMS aligned with ISO 9001:2015 and ISO 27001:2013 (certifications in progress)