Keira Ledger
HKeira Ledger is the Head of Regulatory Operations and Technology Innovation at Syneos Health. Keira is also an Equity, Diversity, Inclusion and Belonging (EDI&B) Committee Member, and a member of TOPRA's Regulatory Operations (Reg Ops) Special Interest Network SPIN
JournalThe strategic role of Regulatory Operations in digital transformation success
This article discusses how Regulatory Operations is evolving from document-centric gatekeeper to data-driven strategic partner, and uses a case study from Syneos Health to show how its RegOps team led an initiative to deploy GenAI tools for patient narratives, CMC extraction and plain language summaries