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.