Clinical Trial Monitoring & Quality Oversight
This service ensures paediatric clinical studies comply with ICH-GCP, ISO 9001, ISO 13485, and all relevant regulatory standards, integrating Quality Management Systems (QMS) and risk-based oversight throughout the study lifecycle. It covers the setup of trial quality systems (SOPs, manuals, quality policies), GCP auditing, management of deviations and serious breaches with CAPA, and trial-specific risk assessments. The service also provides comprehensive clinical trial monitoring, including monitoring plans, Site Qualification (SQV), Initiation (SIV), Monitoring (MOV), Close-out Visits (COV), and centralised/remote monitoring with query resolution. Outputs include validated monitoring reports, risk management plans, CAPA documentation, and fully auditable QMS records, ensuring sustainable compliance and quality in paediatric trials.
