Trusted Audits. Reliable Insights

AQSure delivers end-to-end audit support—including CRO, BA/BE, vendor, and regulatory audits with a focus on uncovering gaps, mitigating risks, and enhancing operational efficiency. Our experienced auditors provide actionable insights that strengthen compliance and process quality..

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AQSure- Third party Audit Services

With over 10 years of hands-on experience in clinical and quality audits, AQSure stands out as a trusted provider of high-quality, reliable third-party audit services across multiple therapeutic areas and clinical programs. Our team has conducted more than 300+ audits in recent years, spanning vendor audits, CRO audits, BA/BE Audits, Pre-regulatory inspections, and compliance assessments, enabling sponsors and CROs to strengthen operational processes, ensure data integrity, and maintain regulatory readiness. Specializing in audit planning, risk assessment, gap analysis, and actionable reporting, AQSure delivers insights that help organizations optimize efficiency and sustain compliance across all sites and systems. Backed by an experienced audit team and technology-enabled workflows, we provide objective, practical recommendations that drive continuous improvement and quality excellence throughout every stage of clinical research.

Core activities include:

Vendor, CRO, & BA/BE Audits

Conduct independent audits to assess operational practices, compliance, and quality across all stakeholders, including Bioavailability/Bioequivalence (BA/BE) studies, ensuring adherence to regulatory standards and protocol requirements.

Compliance Audits Across Therapeutic Areas

Provide audits tailored to study-specific regulatory requirements, therapeutic area standards, and trial complexity, supporting sponsors across diverse clinical programs.

Risk-Based Audit Planning & Execution

Focus audit efforts on high-risk processes, sites, or vendors to optimize resources, mitigate potential risks, and maximize audit effectiveness.

Data Integrity & Documentation Review

Ensure completeness, accuracy, and reliability of trial data, source documentation, and electronic systems, maintaining audit-ready records.

Corrective & Preventive Action (CAPA) Recommendations

Provide practical, actionable steps to address deficiencies and prevent recurrence, improving overall compliance and operational quality.

Technology-Enabled Reporting & Dashboards

Offer sponsors centralized digital access to audit findings, compliance metrics, and follow-up status for transparency and timely decision-making.

Continuous Compliance Monitoring

Provide ongoing oversight to maintain adherence to local and global regulatory standards throughout the clinical trial lifecycle.

Training & Advisory Support for Regulatory Readiness

Support staff and management with guidance, workshops, and consultation to enhance compliance culture, SOP adherence, and inspection preparedness.

Solution:

>Complex Regulatory Requirements: AQSure provides expert guidance and regulatory intelligence, keeping sponsors and CROs updated on local and global regulatory changes, including FDA, EMA, and ICH guidelines. Our auditors ensure that all sites, vendors, and systems implement regulatory updates correctly, maintaining consistent compliance across the entire clinical program.
>Vendor & Site Oversight: Through comprehensive third-party audits, AQSure evaluates both investigative sites and external vendors, identifying process gaps, standardizing practices, and monitoring adherence to protocols. Our structured oversight ensures consistent quality, minimized risks, and streamlined operations across all study partners.
>Data Integrity Risks: AQSure emphasizes robust data verification and audit trails, reviewing source documentation, case report forms, and electronic systems for accuracy and completeness. Our audits detect potential discrepancies early, helping sponsors maintain reliable, high-integrity data that meets regulatory expectations.
>Operational Inefficiencies: By implementing standardized audit methodologies and technology-enabled workflows, AQSure streamlines audit processes, clarifies responsibilities, and enables proactive issue resolution. This results in faster decision-making, reduced delays, and improved overall efficiency in clinical trial operations.
>Limited Expert Resources: AQSure's team comprises experienced auditors with both clinical knowledge and quality system expertise, providing sponsors and CROs access to the specialized skills required for thorough audits, regulatory readiness, and compliance assurance.
>Timely Issue Identification: AQSure employs proactive monitoring and risk-based audit approaches, identifying gaps or non-compliance early. Our actionable reporting and follow-up mechanisms ensure prompt corrective and preventive actions, safeguarding patient safety, data integrity, and overall trial success.

Benefits Of AQSure:

>Regulatory Confidence: Ensure full compliance with local and global regulations, reducing the risk of findings during inspections and maintaining audit readiness at all times.
>Enhanced Data Integrity: Maintain complete, accurate, and reliable trial data through rigorous audit processes, ensuring study validity and regulatory acceptability.
>Operational Efficiency: Streamline workflows, accelerate issue resolution, and standardize audit practices across sites and vendors, resulting in faster decision-making and reduced trial delays.
>Risk Mitigation: Proactively identify gaps and non-compliance early, minimizing potential impacts on patient safety, study outcomes, and regulatory timelines.
>Expert Guidance: Access a team of experienced auditors with deep knowledge of clinical trials and quality systems, providing objective insights and actionable recommendations.
>Continuous Improvement: Leverage AQSure's audit findings to enhance processes, strengthen vendor and site performance, and drive long-term quality excellence.
>Strategic Advantage: Optimize clinical program performance and gain a competitive edge by ensuring high-quality, compliant, and efficient operations across all study sites.