Erin Emshwiller

Data Management Consultant

Erin Emshwiller is a clinical data management expert who partners with sponsors to design and implement high-quality, inspection-ready clinical data strategies across pharmaceutical, biotechnology, and medical device programs. With more than 2 decades of experience in clinical research, she has led data management strategy and execution across the full clinical development lifecycle, including database design and validation, data review planning, vendor oversight, and regulatory submission readiness supporting pivotal trials and regulatory filings. Erin has extensive experience across a wide range of therapeutic areas including, oncology, cardiology, ophthalmology, dermatology, rare diseases, pediatrics, and complex medical devices.

Erin is particularly skilled at strengthening sponsor oversight of CRO partners and establishing practical data governance processes that ensure data integrity, transparency, and regulatory compliance. She has deep expertise across multiple EDC platforms including, but not limited to Medidata Rave, Viedoc, Zelta (Merative/formerly IBM CD), iMedNet, Medrio, Veeva, and is experienced in developing data management plans, edit check strategies, cross-vendor data reconciliation processes, and inspection-ready documentation. Erin works closely with sponsors and cross-functional clinical teams to deliver high-quality, submission-ready clinical data while improving operational efficiency throughout the study lifecycle.