Industry
Contract Research Organisations
Independent GCP audit and quality system assessments for CROs, supporting sponsor oversight obligations, TMF readiness, investigator site qualification and inspection preparation.
The CRO Compliance Environment
Contract Research Organisations occupy a critical position in the clinical development ecosystem. Pharmaceutical and biotechnology sponsors delegate substantial clinical trial activities to CROs, monitoring, data management, regulatory submission support, site management and pharmacovigilance activities. The regulatory accountability for the quality of those activities remains with the sponsor, but the operational responsibility rests with the CRO.
GCP inspections increasingly focus on the sponsor-CRO relationship and the mechanisms by which sponsors maintain effective oversight of delegated activities. When sponsors cannot demonstrate active oversight, or when CRO quality systems are inadequate, both parties face regulatory consequences. Independent GCP audit of CRO quality systems provides sponsors with the objective evidence they need to demonstrate oversight to inspectors.
Sthira Assure GCP audits for CROs cover the full scope of clinical quality management, from SOP systems and training frameworks through operational monitoring quality, data management controls, TMF management and investigator site oversight. We provide structured, evidence-based findings that give sponsors confidence in the quality systems of their CRO partners.
Key Frameworks
- ICH E6(R2)
- EU CTR 536/2014
- FDA 21 CFR Part 312
- EMA GCP Guidelines
- MHRA GCP Guidance
- DIA TMF Reference Model
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Get in TouchTypical Risk Areas
Sponsor Oversight Demonstration
CROs must be able to demonstrate to both sponsors and regulatory inspectors that they have robust quality systems governing clinical trial conduct. Sponsors are required to maintain active oversight of CRO activities, and when they cannot demonstrate that oversight, both the CRO and the sponsor face regulatory consequences. Independent GCP audit of CRO quality systems provides sponsors with the evidence base for their oversight activities.
Data Management and Integrity
Clinical trial data management is a high-risk activity subject to detailed regulatory scrutiny. Inspectors assess whether data handling procedures ensure traceability from source data to clinical database, whether electronic data capture systems are validated and whether data cleaning and query resolution processes are adequately controlled. Data integrity failures in clinical data can invalidate entire datasets and result in marketing authorisation rejection.
Protocol Compliance Monitoring
Clinical monitoring, the process of verifying that a clinical trial is conducted according to the protocol, SOPs and GCP, is a core CRO function. Inspectors assess whether monitoring activities are conducted at appropriate frequency based on risk, whether monitoring visit reports document protocol deviations completely and whether sponsor oversight of monitoring quality is demonstrated.
Subcontractor Oversight
CROs frequently engage specialist subcontractors for specific trial activities, central laboratory services, IMP management, ePRO providers and specialist site support services. The CRO remains responsible for ensuring that these subcontracted activities meet GCP requirements, and must demonstrate active oversight of subcontractor performance through qualification and periodic assessment.
Speak with a GCP Audit Specialist
Contact our team to discuss CRO qualification, oversight audit or GCP inspection readiness requirements.