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.