Clinical Research & CSV CRO Services

1. Computer System Validation (CSV) & Digital Compliance

• Validation of GxP Systems: Comprehensive support for PV, EDC, CTMS, and LIMS validation.
• CSV Lifecycle Management: Expert execution of URS, Risk Assessment, IQ/OQ/PQ, and Validation Summaries.
• Regulatory Frameworks: Strict adherence to 21 CFR Part 11 and EU Annex 11.
• Data Integrity (ALCOA+): Identification and remediation of risks in clinical data flows.

2. CRO Set-up, Expansion & Inspection Readiness

We facilitate global CRO expansion across Clinical and BA/BE domains with a focus on sustainable quality infrastructure.

• QMS Design: Developing SOPs, training systems, and document control architectures.
• Technical Workflow: Facility readiness and rigorous vendor qualification audits.
• Gap Analysis: Detailed regulatory assessments and mock inspections.