Audit & Assurance
Good Clinical Practice Audits
Independent GCP audits for clinical trial sponsors, CROs and investigator sites, assessed against ICH E6(R2), EU Clinical Trials Regulation and FDA requirements.
Executive Overview
Clinical trial conduct must meet GCP standards that protect the rights, safety and wellbeing of trial subjects and ensure the integrity of clinical data submitted to regulatory authorities in support of marketing authorisations. Regulatory inspections of clinical trials, conducted by the EMA, MHRA, FDA and national competent authorities, assess whether organisations have actually implemented GCP, not simply whether they have documented procedures that describe it.
Independent GCP audit provides clinical sponsors and CROs with an objective assessment of their clinical quality systems, investigator site conduct and data management practices before regulatory inspectors arrive. Findings identified in audit can be remediated proactively, findings identified during inspection generate significant regulatory consequences.
Sthira Assure GCP audits are conducted by assessors with direct experience of clinical trial operations, regulatory inspection outcomes and the specific documentation requirements of ICH E6, EU CTR 536/2014 and FDA regulations. We provide the structured, evidence-based assessment that clinical development organisations need to maintain inspection readiness across their trial portfolio.
Regulatory Frameworks
- ICH E6(R2)
- EU CTR 536/2014
- FDA 21 CFR Parts 50, 56, 312
- EMA GCP Guidelines
- MHRA GCP Guidance
- ICH E8 Study Design
Common Compliance Risks
Informed Consent Deficiencies
Informed consent remains among the most frequently cited GCP findings globally. Common deficiencies include consent obtained after study procedures, consent forms not version-controlled, consent not documented before screening procedures and no evidence of adequate subject understanding. Each represents both a regulatory and ethical compliance failure.
Protocol Deviation Management
Inadequate identification, documentation and escalation of protocol deviations undermines data integrity and patient safety. Inspectors expect evidence that deviations are assessed for impact on subject safety and data validity, reported to the sponsor within defined timelines and incorporated into the overall study risk picture.
CRO Oversight Failures
Sponsors that delegate significant clinical trial activities to CROs must demonstrate active oversight of those activities. Regulatory inspectors regularly find that sponsor oversight of CRO performance is inadequate, limited to contractual agreements rather than evidence-based assessment of actual CRO performance and compliance.
Trial Master File Completeness
TMF completeness and contemporaneity is assessed in virtually every GCP inspection. Inspectors find missing essential documents, documents filed in incorrect locations, version control failures and evidence that TMF content does not reflect the actual conduct of the study. Electronic TMF systems present additional validation and access control requirements.
Scope of Services
Common Audit Findings
Frequently Asked Questions
What types of organisations benefit from GCP audits?
Clinical trial sponsors, contract research organisations, investigator sites, academic research institutions and clinical operations groups benefit from independent GCP audits. Sponsor companies with significant clinical programmes are expected to maintain a clinical quality assurance function that includes periodic independent assessment.
Can you audit virtual and decentralised trials?
Yes. We assess GCP compliance in decentralised and hybrid trial models, including remote consent processes, electronic patient-reported outcomes, direct-to-patient IMP supply and remote monitoring programmes. We assess the specific compliance requirements that apply to non-traditional trial designs.
Do you conduct pre-inspection TMF audits?
Yes. TMF readiness audits are a distinct service we offer in preparation for regulatory authority inspection or prior to marketing authorisation submission. We assess completeness against the DIA TMF Reference Model, identify missing essential documents and provide a remediation roadmap.
Which GCP guidelines do you audit against?
Our audits are conducted against ICH E6(R2) (with consideration of E6(R3) developments), EU Clinical Trials Regulation 536/2014, EMA GCP guidance, FDA 21 CFR Parts 50, 54, 56 and 312, and applicable national clinical trial regulations.
Request a GCP Audit
Contact our team to discuss your GCP audit requirements, trial portfolio and inspection readiness needs.