Dave has over 35 years of industry experience with nearly 20 years in the pharmaceutical industry during which time he has been using and helping develop the CDISC standards. During that time, Dave led CDISC Technical work for 2.5 years, been the ODM and SHARE team leads and has co-led HL7’s Regulated Clinical Research Working Group. He has worked closely with the FDA, CDISC, HL7, ISO, IHE and other organisations that promote better electronic processes for medical research. He was the lead author for the CDISC white paper of electronic source data that was used as the basis for EMA’s guidance document.
He currently volunteers with the CDISC XML Technology and define.xml teams and participates in the PhUSE FDA Computational Science Symposium working groups. He is now exclusively focused on the effective management and use of metadata within pharmaceutical companies to improve process and data quality. Dave presents regularly at industry conferences including CDISC, PhUSE and DIA.