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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