Gretchen Neumann

Gretchen Neumann works in the medical industry managing clinical trials. Over her 20-year career, she has managed all aspects of multicenter clinical trials and has managed numerous clinical projects, through development of protocols, informed consent documents, Investigational Review Board (IRB) and Ethics Committee applications, and subsequent interactions with FDA. Ms. Neumann has conducted clinical start-up training, investigator training, clinical report writing, drafted original IDE applications, IDE supplements, and IDE annual reports. She also has extensive experience conducting clinical audits in conformance with Good Clinical Practice and monitoring of clinical trials for Class III significant risk devices to verify conformance with 21 CFR Parts 50, 54, 56, 812 and GCP.