• 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.
  • Contributed to the 2018 ECRINS Standards review.
  • Led a national review of CTU EDC use for the NIHR Digital Programme.
  • Supported a University research institute through a successful ISO27001 audit.
  • Providing ongoing strategic IS support to a CTU.
  • Strategic consultancy to a CTU on EDC systems and UKCRC Registration. 
  • Provided system validation training to a CTU programming team including recommended processes and document templates.
  • Supported a CTU with the procurement of a new EDC system, including market review, systematic evaluation and recommendation.
  • Supported development of a new University-based CTU including staffing structures and roles, computer systems and information governance.
  • Provided strategic advice to a UKCRC Registered CTU on staffing, cost-models and systems.
  • Provided strategic support to a developing CTU on system choice and integration, roles and organisational structure.
  • Assisted two CTUs in achieving provisional UKCRC Registration in 2017. 
  • 'Soft' regulatory-style audit of a UKCRC Registered CTU.
  • Supported a CTU with development of job descriptions and provided expert advice on interview panel.
  • Worked with a CTU to develop database documentation process and templates compliant with regulatory system validation expectations. 
  • Provided advice and guidance to a UKCRC Registered CTU on system validation strategies and practice.
  • Provided advice on national EDC strategy to a major research charity.