For clinical trial sponsors worldwide, selecting and overseeing providers in Australia, New Zealand and the wider Asia-Pacific region requires clear insight into how delegated activities are managed. Quality systems, personnel, sample handling and data processes all warrant careful assessment.
SeerPharma’s Good Clinical Practice (GCP) audit services help sponsors evaluate Clinical Research Organisations (CROs), clinical trial units and vendor audits such as clinical trial logistics operations and testing laboratories. Our audits seek objective evidence of effective processes and identify potential compliance and data integrity gaps, supporting informed provider selection and ongoing sponsor oversight for protection of clinical trial participants.
GCP Audits Supporting Sponsor Oversight
Delegating trial activities requires confidence in an outsourced suppliers' resources, procedures and management arrangements. SeerPharma assesses the systems supporting those activities, including how responsibilities are assigned, work is monitored and issues are communicated. Our GCP audits can examine:
- Personnel and trial management: Staff qualifications, training and competency, resourcing and delegation of duties, project management, study coordination and continuity arrangements.
- Site management and monitoring: Processes for site selection and qualification, site initiation, monitoring and closeout, including oversight of site performance and follow-up of identified issues.
- Quality assurance and Quality Control: Quality management systems, quality assurance and quality control activities, deviation and non-compliance management, vendor oversight and risk management and overall communication within the CRO and with the sponsor.
- Trial documentation and safety processes: Management of Trial Master Files, and Essential Records and adverse event reporting and clinical trial safety reporting procedures.
- Records and computer systems: Document review, management, storage, retention and archiving arrangements, including computerised systems, system validation, access controls, audit trails and data integrity.
These assessments help sponsors understand how a CRO manages its delegated activities and where further clarification, corrective action or oversight may be needed. They support, rather than replace, the sponsor’s own oversight responsibilities.
Clinical Trial Logistics and Testing Audits
The handling of clinical trial samples and the reliability of laboratory data are closely connected. SeerPharma audits operations receiving samples for processing, analysis and storage, examining the processes that connect sample receipt with testing and reporting. Our audits can cover:
- Sample handling and traceability: Receipt, identification, inventory, storage, chain of custody, cold chain controls temperature monitoring, excursion management and shipment to third-party laboratories.
- Laboratory quality systems: Document and record management, personnel responsibilities, trainingand competency, quality assurance and quality control activities, equipment management, supplier and subcontractor oversight, investigation of deviations and non-conformances, and corrective and preventive actions (CAPA)
- Analytical methods and testing controls: Analytical method transfer, verification and validation, documented execution of test methods, incurred sample reanalysis (ISR), measurement traceability, equipment management and management of reference standards, reagents and analytical solutions.
- Data integrity and reporting: Data capture, processing, transfer, analysis and reporting; laboratory information management system (LIMS) configuration and controls for study specific activities; and controls over report review, approval, amendment and reissuance.
For sponsors assessing a new provider or overseeing an existing relationship, these areas provide a basis for examining whether laboratory and logistics processes support the study’s requirements. Particular attention can be given to the interfaces between organisations, where samples, data and responsibilities pass from one provider to another.
Audit Criteria Relevant to Your Study
Audit criteria depend on the activities under review, the study and applicable regulatory requirements. Relevant references may include International Council for Harmonisation (ICH) E6 GCP R3, ICH M10 for bioanalytical method validation and study sample analysis, and the ISO/IEC 17025 laboratory competence standard.
United States electronic records and electronic signatures requirements under 21 CFR Part 11 may also be relevant where applicable. Study protocols, quality agreements, method validation protocols, project plans, data transfer agreements and laboratory manuals can provide additional criteria.
Not every reference applies to every provider or jurisdiction. The audit scope should reflect the services delegated and the requirements relevant to the study.
Discuss Your GCP Audit Requirements
Selecting a provider or reviewing an existing arrangement in Australia, New Zealand or the wider Asia-Pacific region?
Contact us to learn to discuss your study, the activities you need assessed and your audit priorities.
