Clinical Trial & Vendor Audits

ClinAura offers a complete suite of independent clinical trial and vendor audits to help organizations ensure regulatory compliance, data integrity, and inspection readiness. Our audits are conducted in alignment with Global Regulatory expectations.

Our audits evaluate systems, processes, and documentation to ensure regulatory compliance, operational accuracy, and readiness for global inspections. Through proactive risk identification and evidence-based recommendations, we help sponsors and CROs strengthen their overall quality framework.

Project Level audits

Investigator Site Audits

These audits assess the conduct of clinical trials at investigator sites to ensure adherence to the approved protocol, GCP principles, and regulatory requirements. We review site documentation, informed consent processes, subject safety measures, data accuracy, and investigational product accountability. The outcome helps ensure that clinical data is credible, traceable, and verifiable.

Independent Internal Project-Specific Audits (Sponsor / CRO)

We offer independent internal audits for sponsors and CROs to evaluate project-specific activities objectively. These audits assess study documentation, monitoring practices, data management, and trial oversight. Our independent approach ensures unbiased evaluation of compliance and effectiveness at both project and system levels.

Periodic Audits / Routine Quality Reviews

To maintain ongoing compliance, we perform scheduled periodic audits of ongoing studies, systems, and processes. These proactive reviews help identify gaps early, monitor performance trends, and reinforce continuous quality improvement within your clinical operations.

System-Level Audits

Pharmacovigilance (PV) Audits

Review safety reporting processes, case management, signal detection, and safety database integrity to ensure adherence to global PV regulations.

Computer System Validation (CSV) Audits

Assess validation practices for computerized systems to verify compliance with 21 CFR Part 11 and data integrity principles.

Trial Master File (TMF) Audits

Evaluate completeness, accuracy, and accessibility of TMF content to ensure traceability, inspection readiness, and GCP compliance.

Data Integrity Audits

Examine data lifecycle controls across systems and processes to confirm that information remains ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate, and more).

Vendor Qualification Audits

ClinAura conducts qualification and requalification audits of vendors such as CROs, laboratories, data management centers, and eClinical platform providers. These audits evaluate vendor capabilities, compliance history, quality systems, and risk controls—ensuring that external partners meet your organization’s quality and regulatory expectations before or during engagement.

Process and System Audits

ClinAura performs end-to-end process and system audits to assess organizational quality frameworks—covering functions like clinical operations, pharmacovigilance, data integrity, training, and document control. These audits verify the adequacy of SOPs, electronic systems, and controls that support consistent compliance and operational efficiency.