GCP Audits

Clinical data only supports an approval if it was generated ethically, accurately and in compliance with the protocol. PharmExpert's Good Clinical Practice audits give sponsors and CROs independent assurance that investigator sites, vendors and trial master files meet ICH E6(R2/R3) and the relevant regional requirements before an inspection — or a submission — puts them under scrutiny. A finding discovered by your auditor is a problem you can fix; the same finding discovered by an inspector can jeopardize the data and the application.

We audit across the clinical ecosystem: investigator and trial sites, sponsor oversight systems, CRO and functional-service-provider processes, central laboratories, IRT/randomization vendors and the Trial Master File. Each audit assesses the things that determine subject safety and data reliability — informed consent and ethics, eligibility and protocol compliance, source-data verification, investigational-product accountability, safety and adverse-event reporting timelines, and the completeness and contemporaneousness of essential documents.

Our approach is risk-based, consistent with the quality-management thinking embedded in ICH E6(R2). Rather than treating every deviation as equal, we help you see the systemic and critical-to-quality issues that drive inspection risk — distinguishing isolated lapses from patterns that signal a weak oversight system. That perspective is as valuable for sponsor and CRO system audits as it is for individual sites.

Beyond routine programs, we conduct for-cause audits when a quality signal — unusual data, a whistle-blower report, monitoring concerns — demands rapid, independent fact-finding. In every case the output is a clear, referenced report with risk-ranked findings and practical CAPA direction, written to stand up to regulatory review and to help the audited party genuinely improve.