Clinical Quality Services
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Services Offered by j3i
j3i provide a range of clinical quality assurance services for CROs and pharmaceutical companies in the UK, Europe and USA.
Services are mainly provided on a consultancy basis, though we are willing to work on an on-going retainer basis for companies requiring regular quality assurance support.
Audit Services
- Investigator site audits
- CRO/vendor audits
- Data audits
- Systems and Process audits
- See the Auditing section for further details
All audits offered as routine, for-cause or pre-inspection
Quality Systems - development and maintenance
j3i provide development and revision of your Quality System documentation to meet your needs.
- Quality System development or enhancement of an existing system
- Documentation development/revision including Quality Manuals and SOPs
- Corrective and Preventative Action Systems implemented or enhanced
- Work instructions, forms & manuals for everyday on-the-job guidance
- Training materials to complement Quality System documentation
- Audit results metrics to make the best use of your audit results
Training
- Good Clinical Practice (GCP) Training basic, refresher and update training
- Clinical Trial Directive 2001/20/EC, GCP Directive 2005/28/EC and GMP Directive 2003/94/EC
- Data Protection and HIPAA privacy rules
Consultancy
Expert consultancy and pragmatic advice offered for a wide range of topics including the following:
- Inspection readiness
- Quality systems
- Gap analysis to identify areas for improvement
- Process improvement
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