• Strategic consultancy to a CTU with advice on EDC systems, and expectations of UKCRC Registration
  • 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.
  • Strategic advice to a CTU on staffing, cost-models and systems.
  • 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.
  • Preparation 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.