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Clinical Auditing Services
All clinical research companies need to implement an effective audit programme. j3i can provide expertise in the audit arena and work with existing staff, CROs and contractors to ensure that the audits are conducted efficiently and provide results that evaluate compliance status as well as opportunities for process improvement.
Investigator Site Audits
- Routine, for-cause and
pre-inspection
- UK/International
- All therapeutic areas
- Your SOPs/templates or j3i\'s
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CRO Audits
- Pre-contract assessments and during study audits
- All types of CROs:
- Clinical / Data management
- IVRS
- Medication packaging & distribution
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System/Process Audits
- Process-based and systems audits across all areas,including
- Pharmacovigilance/Drug Safety
- Investigational Medicinal Product (IMP)
- Data Management
- Monitoring activities
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Data and Report Audits
- Database audits, including
Electronic Data Capture systems
- Data Management processes
- Clinical Study Reports and other outputs
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