RISG Consulting was formed in 2017 by Will Crocombe, IS Director at the University of Leeds' Clinical Trials Unit for over 15 years. Will was instrumental in developing the Leeds CTU into a leading national unit with well respected information systems support. Will set up the original national NCRN CTU IS working group in 2001 and chaired it successfully for over a decade as it became incorporated into UKCRN, NIHR and now UKCRC. Will has worked on several high-profile national clinical trial projects with NIHR including a national EDC system review and authorship of the DIMS report (now part of the European ECRINS standards), worked closely with CRUK, NHS Digital, provided expert IS input into UKCRC CTU registration assessments and was a member of the registration panel. Will has provided consultancy to various CTUs on EDC system review and procurement, system validation, regulatory and audit support and strategic management. Will is a member of ISPE, an enthusiastic advocate of pragmatic validation methods and has presented on system validation topics, most recently for Applied Clinical Trials. Will is based in Leeds and when not working enjoys life in the great outdoors, particularly mountain biking - occasionally through rivers.