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GCP COMPLIANT · INDEPENDENT · SYSTEMATI
Independent, systematic clinical trial audit services supporting sponsors, CROs, and research organisations in maintaining the highest standards of quality and data integrity.
FULLY COMPLIANT
GUIDELINE ALIGNED
INSPECTION READY
STANDARDS ALIGNED
ABOUT OUR INDEPENDENT AUDIT
At IQVAMED, our Clinical Trial Audit Services support sponsors, CROs, and research organisations in maintaining high standards of quality, regulatory compliance, and data integrity across all clinical research activities.
Our independent and systematic audits evaluate trial processes, documentation, systems, and operational practices to ensure alignment with Good Clinical Practice (GCP), regulatory guidelines, and study protocols. We help organisations identify risks early, strengthen quality systems, and ensure readiness for regulatory inspections.
Unbiased, objective audits free from operational influence or conflicts of interest.
All audits are conducted in strict accordance with ICH-GCP E6(R2), EMA, FDA and local regulations.
Focused, prioritised audits using risk-based methodologies to maximise impact and efficiency.
From investigator site evaluations to CAPA assessments, our full portfolio of clinical study audit services is designed to protect data integrity and ensure regulatory readiness at every stage of your trial.
On-site and remote audits of investigator sites to evaluate adherence to the approved protocol, GCP requirements, and applicable regulatory guidelines. We assess informed consent procedures, source data verification, trial documentation, and site staff qualifications. Our audits identify protocol deviations, data integrity concerns, and areas requiring corrective action, providing sponsors with a comprehensive picture of site performance and compliance status.
Enquire NowStructured qualification audits of third-party vendors supplying critical services or products to clinical trials — including central laboratories, imaging CROs, eClinical technology vendors, and specialty service providers. We assess vendor quality management systems, SOPs, validation status, data handling procedures, and regulatory compliance. Our vendor qualification process helps sponsors make informed decisions about vendor selection and ongoing oversight, reducing third-party risk across the supply chain.
Enquire NowComprehensive qualification audits of Contract Research Organisations prior to or during engagement, evaluating their infrastructure, processes, systems, and quality culture. We examine CRO capabilities across clinical operations, data management, pharmacovigilance, regulatory affairs, and biostatistics. Our audits verify that the CRO's quality management system meets sponsor requirements and regulatory standards, ensuring that delegated responsibilities are handled with appropriate oversight, expertise, and accountability.
Enquire NowEnd-to-end audits of clinical study conduct, encompassing all key operational areas including clinical operations, data management, safety reporting, and regulatory submissions. We evaluate the overall study management framework — examining sponsor oversight, monitoring effectiveness, protocol adherence, and the quality of clinical data throughout the trial lifecycle. Our audits provide sponsors and sponsors' representatives with assurance that the clinical study is being conducted in accordance with GCP and applicable regulations.
Enquire NowRemote, data-driven audits conducted from a centralised location, enabling efficient oversight across multiple sites and geographies simultaneously. Centralised audits leverage statistical analysis, risk signals, and electronic data review techniques to identify trends, anomalies, and compliance concerns without the need for on-site visits. This approach supports sponsors and CROs in implementing robust centralised monitoring programmes and is particularly effective in hybrid or decentralised trial models where traditional site visits are limited.
Enquire NowSpecialised audits of bioanalytical laboratories and study conduct, assessing compliance with EMA and FDA bioanalytical method validation guidelines. We evaluate method validation data, sample management, analytical run procedures, data integrity controls, and documentation practices. Our bioanalytical audits ensure that pharmacokinetic and pharmacodynamic data generated in support of clinical programmes meet the highest standards of scientific rigour and regulatory acceptability, minimising risk of data challenges during regulatory review.
Enquire NowExpert audit services for In-Vitro Permeation Test (IVPT) studies, evaluating compliance with FDA guidance on topical drug products including dermatological formulations. We assess the conduct of IVPT studies including membrane preparation, donor compartment composition, receptor fluid composition, sampling procedures, and analytical methods. Our auditors bring specialist knowledge of human skin permeation studies and dermal pharmacokinetics, supporting sponsors in ensuring the regulatory acceptability of in vitro comparative data used in NDA and ANDA submissions.
Enquire NowComprehensive quality review of Clinical Study Reports prior to regulatory submission, ensuring completeness, accuracy, internal consistency, and compliance with ICH E3 guidelines. We evaluate the alignment between the CSR narrative, statistical analysis, data listings, and patient profiles. Our reviewers assess the scientific integrity and regulatory acceptability of the report, identifying errors, inconsistencies, or gaps that could attract questions from regulatory agencies, supporting high-quality submissions and efficient review cycles.
Enquire NowTargeted pre-inspection audits designed to prepare organisations for regulatory authority inspections by the FDA, EMA, MHRA, and other global health authorities. We conduct a thorough mock inspection of clinical study conduct, documentation, quality systems, and sponsor oversight activities, using the same lens and expectations as regulatory inspectors. Our findings enable organisations to proactively identify and remediate deficiencies before inspection, significantly reducing the risk of critical findings and improving overall inspection outcomes.
Enquire NowSystematic evaluation of clinical research activities against GCP standards, including ICH E6(R2) and applicable national regulations. Our GCP compliance audits assess the full spectrum of trial conduct — from protocol development and site initiation through to study close-out — examining sponsor procedures, monitoring activities, site performance, data management, and safety reporting. We provide detailed audit reports with actionable observations, enabling organisations to strengthen their GCP compliance framework and foster a culture of quality across clinical operations.
Enquire NowDetailed audits of the Trial Master File — both paper and electronic (eTMF) — assessing completeness, accuracy, timeliness, and accessibility against the DIA TMF Reference Model and applicable regulatory requirements. We evaluate the TMF management process, filing workflows, completeness metrics, and the quality of individual artefacts, identifying gaps and deficiencies that could compromise the reconstructability of trial conduct. Our TMF audit reports enable sponsors and CROs to maintain inspection-ready documentation at all times throughout the trial lifecycle.
Enquire NowExpert review and assessment of Corrective and Preventive Action (CAPA) plans arising from audits, inspections, or internal quality reviews. We evaluate the root cause analysis, the adequacy of proposed corrective actions, preventive measures, timelines, and effectiveness checks. Our CAPA reviewers draw on regulatory inspection experience to assess whether the organisation's response is likely to satisfy regulatory authority expectations, and provide guidance on strengthening CAPA quality to prevent recurrence and demonstrate a robust quality management system.
Enquire NowWe work closely with your team to define the audit scope, objectives, and criteria. A detailed audit plan is prepared and agreed, outlining timelines, personnel, and documentation requirements.
Our qualified auditors conduct a rigorous, systematic evaluation — on-site or remote — reviewing documentation, interviewing personnel, and observing processes against established GCP standards.
All observations are documented with clear risk classifications. A comprehensive audit report is delivered, providing transparent, actionable findings and recommendations for remediation.
We support the development and review of CAPA plans, providing expert guidance to ensure corrective actions are adequate, timely, and effective in preventing recurrence.
Our auditors are not generalists — they are senior clinical quality professionals who have spent careers inside the industry, conducting audits, navigating regulatory inspections, and building quality systems for leading global sponsors and CROs. When you engage IQVAMED, you get depth of experience that shows in every audit report.
Our team has performed over 125 investigator site audits across multi-national clinical trials, spanning Phase I through Phase IV studies in therapeutic areas including oncology, CNS, cardiovascular, infectious disease, and rare conditions.
With more than 25 vendor and CRO qualification audits to their name, our auditors bring structured, evidence-based assessment skills to evaluate third-party organisations against GCP requirements and sponsor expectations.
Each IQVAMED auditor brings between 15 and 35+ years of hands-on clinical research experience — spanning sponsor, CRO, and regulatory environments — providing unparalleled insight into what constitutes true GCP compliance.
Our auditors have direct experience on both sides of regulatory inspections — having prepared organisations for FDA, EMA, and MHRA authority inspections and worked within quality systems that have faced real regulatory scrutiny.
Our auditors hold expertise across diverse therapeutic areas and trial phases — from early-phase bioanalytical studies to large-scale Phase III multi-centre trials — ensuring audit insights are always contextually relevant and scientifically grounded.
Beyond conducting audits, our team has designed, implemented, and led quality management systems at the organisational level — giving them the broader perspective to assess not just individual findings but systemic quality culture.
Our auditors remain actively engaged with evolving regulatory guidance, industry working groups, and professional bodies — ensuring that every IQVAMED audit reflects the most current interpretation of GCP expectations and regulatory trends.
All audits conducted to the latest GCP standards
FDA, EMA, MHRA, and multi-regional submissions
Strict data governance and confidentiality protocols
Efficient delivery without compromising quality or depth
As a fully independent audit organisation, our findings are objective and free from any operational bias. Our independence is our credibility — and yours.
Our auditors have direct regulatory inspection experience and deep knowledge of FDA, EMA, and MHRA expectations, giving our clients unparalleled insight into what regulators look for.
From site audits to bioanalytical and IVPT assessments, our comprehensive service range means you have a single, trusted partner for all your quality assurance needs.
We deliver reports that are precise, well-reasoned, and practically useful — giving your team the clarity and direction needed to remediate efficiently and confidently.
Whether you are planning a new audit programme, preparing for a regulatory inspection, or seeking an independent quality partner, our team is ready to help. Reach out to discuss your needs.
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