Quality Assurance: Inspection-Ready Trials
We offer comprehensive quality assurance services to ensure that clinical trials meet the highest standards of regulatory compliance, data integrity, and operational excellence. Our independent audits and oversight assessments help ensure that your trial is inspection-ready and aligned with best practices.
- Performing independent site audits
We conduct independent site audits to assess compliance with Good Clinical Practice (GCP), regulatory requirements, and study protocols. These audits help identify potential issues early and ensure sites are operating to the highest standards.
- Inspection readiness activities
Our inspection readiness services prepare sites and sponsors for regulatory inspections, ensuring that all documentation, processes, and systems are in place. We conduct mock inspections and provide guidance on addressing potential gaps to ensure full preparedness.
- Independent quality oversite assessment
We provide independent quality oversight assessments to review and evaluate the overall quality management of clinical trials. Our objective evaluations ensure that trials are being conducted in compliance with all regulatory and ethical standards, safeguarding data integrity and patient safety.