Data Protection and Privacy
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 (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.