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Independent Third Party Audit

Ensuring Regulatory Compliance with Independent Audits

01Third Party Audit Service

Ensuring Regulatory Compliance with Independent Audits

We offer comprehensive Third Party Audit Services to ensure that your clinical trials, bioanalytical processes, and documentation meet the highest standards of quality, compliance, and regulatory requirements (FDA, EMA, ICH).

Our unbiased, expert auditors provide the critical assessment needed to identify gaps, mitigate risks, and ensure submission readiness, acting as a trusted external review partner.

02Key Areas

Key Areas of Our Third Party Audit Services

GxP Audits (GCP, GLP, GMP)

Independent assessments to ensure full compliance with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP) standards across all phases of your research.

Clinical Data Audits

Verification of the accuracy, completeness, and integrity of clinical trial data. This includes reviewing source documents, Case Report Forms (CRFs), and Clinical Data Management Systems (CDMS).

Regulatory Compliance Audits

Thorough review of trial documentation, protocols, and regulatory submissions to ensure adherence to global regulations, including FDA, EMA, and ICH guidelines. Essential for pre-inspection readiness.

Process Audits & QA System Review

Evaluation of operational workflows, including site management, patient recruitment, and SOPs. Identifying inefficiencies and areas for improvement in your Quality Assurance system.

Unbiased, expert auditors acting as a trusted external review partner

Audits that leave you inspection ready

Features

  1. GxP Coverage
  2. Audit Scope
  3. Global Regulators
  • Good Clinical PracticeClinical
  • Site managementProcess
  • Patient recruitmentProcess

GxP audits across every phase

Independent assessments of compliance with GCP, GLP and GMP standards across all phases of your research.

What we review
  • SDSource documentsClinical data audit
  • CRFCase Report FormsClinical data audit
  • DBClinical Data Management SystemsClinical data audit
  • PRProtocolsRegulatory compliance
  • SUBRegulatory submissionsPre-inspection readiness
  • SOPSOPs & workflowsProcess & QA review

Data, documents and process

Verification of the accuracy, completeness and integrity of trial data, a thorough review of documentation and submissions, and evaluation of operational workflows.

Guidelines
  • FDA
  • EMA
  • ICH
  • GCP
  • GLP
  • GMP

Actionable findings

Clear recommendations to correct findings, so your studies withstand the scrutiny of regulatory bodies worldwide.

As experienced 3rd party audit companies, MTRL provides objective insights critical for risk mitigation. Our reports offer clear, actionable recommendations to correct findings, ensuring your studies can withstand the scrutiny of regulatory bodies worldwide.

Partner with us for your third party audits to protect your investment and accelerate your path to regulatory approval.

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Clinical Data Management

Accurate and Reliable Clinical Data Management

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