Strategic consultancy

  • Information systems and governance
  • TRE/SDE policy, design and governance 
  • Clinical trial EDC systems, procurement and implementation
  • Staffing structures, management and leadership

System validation

  • Guidance and training on system validation principles and pragmatic implementation
  • Regulatory-compliant system documentation and quality assurance processes
  • Support with system validation, planning and risk-based approaches

Regulation and audit

  • Advice on regulatory audit expectations (e.g. MHRA, NHS)
  • Audit preparation and dealing with fallout
  • Soft audits and recommendations

Data protection and governance

  • NHS DSPT compliance and submission support
  • Data protection advice
  • Legal and ethical framework for data sharing
  • Advice on data anonymisation and risk
  • Standard processes and quality assurance in information systems.