Services

• Quality assurance advisory service
  
  • GCP, GCPV, Drug Safety - Pharmacovigilance
    
    
• Training on GCP and related aspects of clinical development
  
  • Customised in-house training
  • Clinical research staff and auditors
    
    
• Coaching of clinical research staff and auditors
  
  • In groups or one-on-one
    
    
• Quality management and system evaluation and design
  
  
• Process evaluation and improvement
  
  
• Risk assessment workshops
  
  
• Preparation and training for regulatory inspections
  
  
• 'For cause' GCP audits
  
  
• Available to work world-wide

Previous experience

• Over 20 years experience in the Pharmaceutical Industry, in the areas of product development, clinical trial material production, clinical research and quality assurance
  
  
• Set up and developed a European Clinical Research department for a large multi-national covering all aspects of clinical development, including, quality system management, trial planning, conduct and reporting, training, data management, and adverse event reporting for all phases of trial
  
  
• In the clinical quality assurance function I conducted process, sponsor, laboratory, third party and site assessments and audits world-wide
  
  
• Provided advice, coaching and consultancy on quality assurance in GCP and GCPV
  
  
• Regulatory agency inspections - education and preparation of sponsor and site staff and hosting of inspections
  
  
• Co-author of the ENGAGE guideline for Good Clinical Practice Compliance and Quality Systems Auditing

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