Kristin Kelly is a Principal Consultant at Pinnacle 21 in the Clinical Data Standards group. Kristin has over 10 years of experience working in the pharmaceutical industry primarily focused on clinical data standards. Prior to joining Pinnacle, Kristin was an Associate Director at Merck in the Global Clinical Data Standards (GCDS) group. She was also worked a consultant in Data Standards Consulting (DSC) for Accenture (formerly Octagon Research Solutions). She provides guidance on CDASH and SDTM standards to both internal project teams and external clients. Kristin is also involved with the CDISC SDS team, TAUG teams, SEND Core Team, as well as several PHUSE CSS Working Groups. Kristin has led several SDTM conversion projects for submission to both CDER and CBER that have resulted in FDA approvals. Kristin holds a B.S. in Biology from Saint Joseph’s University.