Strategic consultancy

  • Infrastructure and system design.
  • Expert advice on EDC systems, procurement and implementation
  • System specification, procurement or bespoke design, implementation and integration.
  • Staffing structures, management and leadership.

System validation

  • Guidance and training on principles of system validation and pragmatic implementation (GAMP CSA advocate).
  • Regulatory-compliant system documentation and quality assurance processes.
  • Support with validation of REDCap, validation plans and risk-based approaches.

Regulation and audit

  • Advice on regulatory audit expectations (e.g. MHRA, NHS Digital).
  • Audit preparation and response to findings.
  • 'Soft audit' and recommendations.

Data protection and governance

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