Our Services

HolistiNova provides comprehensive, premium Quality Assurance audits and consulting services for clinical trials.

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Clinical Site Audits

Pre-study, interim, and closeout audits to assess GCP compliance, site readiness, and protocol adherence. Tailored for sponsors and academic investigators alike.

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Trial Master File (TMF) Audits

In-depth TMF reviews to ensure document completeness, accuracy, and inspection readiness per ICH-GCP and FDA guidelines.

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Mock FDA Inspection Readiness

Simulated inspections to prepare research teams and sites for regulatory audits. Includes document review, staff training, and corrective action planning.

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SOP Development & Review

Creation and revision of standard operating procedures to align with regulatory expectations and your internal workflows.

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Quality Consulting (Retainer & Project-Based)

Ongoing or project-based QA support tailored to your specific trials or program. Advisory on process improvement, risk mitigation, and compliance strategy.

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Quality Management Plan (QMP) Development

Strategic development of sponsor-level or study-specific QMPs, including risk-based approaches, oversight mechanisms, and performance metrics.