Pharmaceutical quality management services from j3i Value Added CQA Services Contact j3i on +44 118 977 1736 for international clinical quality management services
 
 

Clinical Quality Services

Clinical quality services from j3i for pharma companies and CROs

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