Supported a UKCRC Registered CTU with validation of REDCap, including validation plan, detailed implementation guidance and regulatory documentation.
Provided EDC validation advice to an NHS research group.
Leading an EDC system validation project for a UKCRC Registered CTU.
Supporting an national research programme with implementation of an EDC system.
Built a REDCap database for an international cardiac trial.
Systems audit of a UKCRC Registered CTU on behalf of an NHS sponsor.
Co-ordinating functional requirements gathering from users of a national hospital-based CTMS.
Contributed to NIHR COVID19 response by leading feasibility assessment of a rapid national EDC solution to support urgent research.
Providing expert input to a cross-agency (NIHR, MHRA, HRA) project to implement data standards.
Provided expert guidance to a national data registry on provision of secure data services.
Strategic review of IT system architecture and infrastructure for a UKCRC Registered CTU.
Providing IG and technical guidance to a university-based national research centre in procuring a secure data storage facility and developing a bespoke online database.
MHRA-style audit of IT infrastructure and databases (focus on system validation) for a UKCRC Registered CTU.
Provided mentoring and guidance to a new CTU IT lead.