Dave Iberson-Hurst founded Assero in 2003 to provide consultancy services to industry and develop products and solutions to bring global standards adoption closer to reality. Over the past 15 years, Dave has been instrumental in the development of industry standards for CDISC and has been regularly required to advise both the industry and its regulators on some of the challenges faced when implementing standards.
Dave a thought leader on the management of metadata within pharmaceutical companies and has a vision of how a company’s metadata can bring about improvements in the flow of clinical data saving time, while maintaining data integrity during the trial process. He has successfully implemented this vision within several companies and has led the CDISC SHARE project team, to deliver one source of industry metadata that can be used for multiple purposes.
Dave has worked with the CDISC standards for 15 years and has been a volunteer within the standards community for the same period of time. During that time he has worked within, and lead, several CDISC teams, presented in many forums in Europe, the US and elsewhere across the globe and has worked closely with the FDA, HL7, ISO, IHE and other organizations that promote better electronic processes for medical research.
Dave specializes in working with CDISC ODM, define.xml, CDASH, SDTM and the CDISC terminology and is comfortable with both the CDISC content and the associated technology. Be it managing content with excel, using XML, the semantic web or some other technology a solution can be found to make effective use of standards in your environment working within the constraints you face.
Currently Dave is actively involved within the CDISC XML Technology and define.xml teams, the CIDSC Technical Leadership Committee and the PhUSE FDA Computational Science Symposium Semantic Technology working group and the Emerging Trends and Technologies working group.