STRATEGIC ENABLEMENT SERVICES

Clinical Trial Auditing & Monitoring Services

Advarra’s Clinical Trial Auditing & Monitoring services deliver comprehensive support across the research lifecycle through auditing, monitoring, and inspection readiness services — ensuring compliance and reducing audit risk.

Advarra’s experts assess Good Clinical Practice (GCP) compliance and quality and operational practices through targeted assessments and impactful recommendations to promote trial integrity and strengthen compliance.

Why Choose Advarra’s Clinical Trial Auditing & Monitoring Solution?

Seasoned Team

25+

Years of experience developing, implementing, managing, and monitoring clinical research programs

International Presence

75+

Countries of global research presence

Languages spoken by auditors

Regulatory Expertise

10+

years of experience and expertise across international and local regulatory requirements, including the FDA, EMA, and other global agencies

Clinical Trial Auditing & Monitoring Services

Inspection readiness

Inspection readiness provides realistic mock inspections and expert guidance to help research sites respond and perform with confidence during any regulatory review.

ICH HCP E6(R3) training & readiness

ICH HCP E6(R3) training & readiness helps sites and institutions bridge regulatory gaps, refine SOPs, and align operations with the latest ICH guidance, backed by comprehensive training, implementation support, and ongoing compliance oversight.

Quality assurance & compliance support

Quality assurance & compliance support strengthens institutional compliance by identifying gaps, reducing risk, and embedding quality across the research lifecycle. Through tailored evaluations, SOP development, risk-based QA plans, audits, KPIs, and CAPA guidance, this service augments your QA function with expert support that drives consistent, sustainable quality.

GCP audits

GCP Audits provide independent evaluations of clinical trial conduct across sites and vendors to identify compliance risks and operational gaps. Delivering clear, actionable findings and CAPA guidance, this service strengthens quality, ensures adherence to GCP standards, and enhances overall inspection readiness.

Mergers & acquisitions due diligence audits

Mergers & acquisitions due diligence audits help research sites uncover hidden risks, confirm compliance, and strengthen positioning for mergers, acquisitions, and strategic partnerships.

Good Manufacturing Practices (GMP), Good Laboratory Practice (GLP), and Computerized systems validation (CSV) audits

GMP, GLP, and CSV audits helps research sites uncover gaps, validate systems, and ensure operations meet the highest regulatory expectations.

Post-approval monitoring for investigator-initiated trials

Post-approval monitoring for investigator-initiated trials helps institutions protect participants, ensure compliance, and strengthen the integrity of investigator-initiated trials through expert monitoring, regulatory reviews, CAPA management, and hands-on investigator training.