In the last 35+ years, Steffan has worked at four Phase I sites, for three companies on two continents. As a student, and later, he took part as a participant in several Phase I trials. In his career he has drawn blood, taken ECGs, worked night shifts, spiked controls in the HPLC and GC-MS labs, taken the minutes at Ethics / IRB Committee meetings, QC'd clinical pathology data transfers, hand-calculated AUCs, hosted FDA inspections and audited every single data point in many CSRs. He has held leadership roles in Quality Assurance, Quality Management, Clinical Operations and Biometrics. More recently he has worked for all the major early phase eSource vendors in roles including oversight of support, customer onboarding, quality management, computer systems validation and solutions consulting. Steffan gained a degree in Zoology and Genetics (1987) at Cardiff University in Wales, back in the days when you had to type your dissertation on a mainframe computer, using a text editor. He is a former board member and honorary fellow (HonFICR) of the Institute of Clinical Research.