Trusted Audits. Reliable Insights

Third-party Audit Services
aqnix Medical Team

AQSure provides independent, high‑quality audits that safeguard compliance, strengthen quality assurance, and maintain inspection readiness across the clinical research landscape

AQSure delivers independent audits that ensure compliance, reinforce quality assurance, and maintain inspection readiness across the full spectrum of clinical research. With a risk‑based, technology‑enabled approach, AQSure empowers sponsors, CROs, and vendors to strengthen operational processes, safeguard data integrity, and achieve global regulatory confidence.

Core Activities:

>Clinical Site Audits: Evaluating site operations, documentation, and adherence to protocols.
>Sponsor & CRO Audits: Independent assessment of sponsor and CRO processes for compliance and efficiency.
>Vendor, CRO, & BA/BE Audits: Qualification and oversight of vendors, CROs, and bioequivalence studies.
>Regulatory Inspection Preparation & Mock Audits: Simulated inspections to identify gaps and strengthen readiness.
>Compliance Audits Across Therapeutic Areas: Ensuring adherence to GCP and international standards.
>Trial Master File (TMF) Audits: Verification of completeness, accuracy, and inspection readiness.
>Risk-Based Audit Planning & Execution: Tailored strategies aligned with study complexity and risk profile.
>Data Integrity & Documentation Review: Detailed evaluation of essential records for accuracy and compliance.
>Corrective & Preventive Action (CAPA) Recommendations: Actionable guidance to resolve deficiencies.
>Technology-Enabled Reporting: Transparent, real-time insights for sponsors and CROs.
>Continuous Compliance Monitoring: Sustained oversight to minimize risks and reinforce quality systems.
>Training & Advisory Support: Preparing teams for inspections and regulatory readiness.

Key Benefits:

>Regulatory Confidence: Minimized inspection risks and strengthened sponsor assurance.
>Quality Assurance Excellence: Proactive identification of gaps with clear, actionable findings.
>Operational Integrity: Comprehensive evaluation of processes, documentation, and compliance systems.
>Risk‑Based Oversight: Tailored audits aligned with study complexity and global standards.
>Trusted Partnership: Reinforced credibility and long‑term confidence between sponsors, CROs, and regulators.

Outcome

Enhanced regulatory confidence, minimized inspection risks, and reinforced research integrity—ensuring trials are conducted to the highest global standards.

REQUEST PROPOSAL