Ashley Prasse
Consultant
Ashley joined Halloran Consulting Group in 2011 and focuses on Halloran's Clinical and Regulatory Consulting. Ashley assists clients with clinical and preclinical program management and monitoring. She has worked with pharmaceutical and medical device companies on organizational and program gap analyses, regulatory and clinical documentation and filing, and the development of Quality System documents and training materials.
Ashley is part of an internal collaboration that provides regulatory, clinical, and quality updates quarterly. Prior to joining Halloran, Ashley was a Human Research Coordinator II in the Office for Human Research Studies at the Dana-Faber Cancer Institute where she supported the SRC and IRB processes for all relevant research conducted under Dana-Farber/Harvard Cancer Center. During her time at Dana-Farber, Ashley focused on submissions, reviews, and maintenance of clinical trials, and received training on GCP, GLP, GMP, ICH guidelines and Collaborative Institutional Training Initiative (CITI).
Prior to Dana-Farber, Ashley was a Research Associate II at Pulmatrix where she obtained respiratory, virology, bacteriology, QA, QC, assay development, SOP, and intellectual property experience. At Pulmatrix, she also monitored all preclinical pharmacology, toxicology, and proof of concept studies conducted at various CRO's in both the U.S. and Canada.
Ashley holds a B.S. in Toxicology from The Pennsylvania State University and is pursuing CRA certification and an M.S. in Regulatory Affairs for Drugs, Biologics, and Medical Devices at Northeastern University.