Clinical Research & CSV CRO Services

1. Computer System Validation (CSV) & Digital Compliance

• Validation of GxP Systems: Comprehensive support for PV, EDC, CTMS, and LIMS.
• 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.
• Inspection-Ready Documentation: Providing full traceability and robust validation reports.

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.
• Defense Strategy: Expert support for sponsor and global regulator interactions.

3. GCP / GLP / GVP Audits & Inspection Defense

Our zero-critical-observation focused approach prepares your organization for the world's most stringent health authorities.

• Risk-Based Auditing: Internal, Vendor, and System audits for GCP, GLP, and GVP.
• Agency Preparation: Dedicated readiness programs for USFDA, EMA, MHRA, DCGI, and WHO.
• Real-time Audit Support: Expert query management and back-room support during inspections.
• CAPA Strategy: Efficient response drafting and verification of corrective actions.