- 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.
- Guidance and training on principles of system validation and pragmatic implementation.
- Regulatory compliant system documentation and quality assurance processes.
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 IG Toolkit.
- Standard processes and quality assurance in information systems.