GxP Audit Services

As an independent consulting company, Montrium can audit your projects managed by your vendors and CROs with a new unbiased eye. Montrium can help elaborate successful internal audit programs with our experienced GxP audit team.

Multilingual GxP Auditors also carry out audits based on projects, studies, processes and systems in accordance with industry standards and regulatory requirements. We conducted more than 1,000 GxP audits worldwide (North America, Europe, Latin America, Middle East, Asia and Australasia) in various types of Investigational Medicinal Products (drugs, biologics, vaccines, medical devices) and various therapeutic areas.

GxP Audits are conducted in accordance with Montrium or Client SOPs with a standard workflow (audit program development, planning, conduct, reporting, evaluation of auditee corrective action plans, follow-up activities, full traceability of audit records, metric development). GxP Audit types include:

  • Sponsor and Process Improvement Audits:
    Evaluation of the clinical development workflow and recommendation of solutions for implementing standard processes in order to improve efficiency and quality.

  • Due Diligence Audits:
    Independent assessment of a clinical development program to assist Client in the licensing or acquisition process of a new Investigational Medicinal Product.

  • CRO Qualification Audits:
    Assessment of all the activities and deliverables undertaken by the CRO on behalf of the Sponsor.

  • Trial Master File Audits:
    Review of essential documents according to ICH GCP, regulatory requirements and SOPs.

  • Investigational Site Audits:
    Assessment of clinical center and compliance monitoring with applicable regulations and identification of GCP deficiencies.

  • Phase I, Bioequivalence/Bioavailability Audits:
    Assessment of facilities, equipment, procedures, PK laboratory processes, study data and personnel.

  • Clinical Trial Rescue Audits:
    Comprehensive review of missing elements or bottlenecks in a specific clinical trial with comprehensive data monitoring.

  • Pharmacovigilance Audits:
    Assessment of pharmacovigilance processes including SAE triage and management, completeness of causality assessment, appropriate use of technology in processing events.
  • Ethics Committee Audits:
    Evaluation of Central Ethics Committee processes including EC member qualifications and training, study review records, meeting minutes and review/approval processes.

  • Clinical Database and Data Management/Biostatistics Audits:
    Assessment and comparison of clinical data in datasets against CRF data.

  • Clinical Study Report Audits:
    Assessment of the CSR to ensure that the report is in compliance with ICH guidelines, Statistical Analysis Plan and Protocol; and correctly reports and summarizes the clinical data.

  • GCP inspection readiness Audits:
    Conduct of Mock Pre-approval Inspection Audits and assisting Sponsor Team to prepare for Pre-approval Inspections by regulatory authorities

  • Non-Clinical GLP Study audits:
    Review of non-clinical toxicology studies and study data.

  • Laboratory Audits:
    Assessment of R&D, clinical, analytical, Central Reading Facilities (e.g ECG, radiology) and reference laboratories participating in clinical trials, including subject data records.

  • GMP Audits:
    Assessment of GMP compliance of clinical trial supplies service provider and manufacturing sites.

  • Computer Systems Audits:
    Assessment of System Development Life Cycle, validation packages for Clinical Data Management Systems, LIMS or other data collection systems like IVRS and EDC.

  • Record and Sample Management Audits:
    Assessment of facilities and processes for long-term record management and clinical trial specimen management.

Please contact us to learn more about the specific auditing services you are interested in.

“Montrium can help elaborate successful internal audit programs with our experienced GxP audit team. ”