Gary Cunningham, company founder/president and consultant, possesses a unique and diverse set of skills that will help your organization soundly meet its clinical data transformation, analysis, reporting, and regulatory submission requirements.
Gary has over 25 years of clinical pharmaceutical SAS® programming experience, including 5 years primarily focused on biostatistical analytical support; first-hand knowledge of the CDISC SDTM, ADaM, and define.xml submission data standards; and 10+ years of CDISC SDTM and ADaM data mapping and transformation experience.
Gary has been a member of the CDISC SDS Team since early 2003, is a contributor to the CDISC SDTM and Implementation Guide publications, is a co-leader of the CDISC SDS Questionnaires, Ratings, and Scales Sub-team, is a co-founder of the Delaware Valley CDISC Users Network, and was a recipient of an FDA Leveraging and Collaboration Award in 2005 for work on the development of the SDTM standard.
Gary also holds a Master of Science degree in Statistics from Temple University.
CDISC = Clinical Data Interchange Standards Consortium
SDTM = Study Data Tabulation Model
SDS = Submission Data Standards
ADaM = Analysis Data Model