Wendy Schroeder
Principal Strategy Consultant, Clinical
NAMSA
Wendy has been involved with research and clinical trials for more than 25 years, and has a deep understanding of medical devices including in vitro diagnostics (IVDs) and companion diagnostics (CDx). She has served as a key company stakeholder in the implementation of an in-house contract research organization (CRO) infrastructure for a commercial laboratory moving bench IVD science into clinical validation studies and launching a biorepository of blood samples with annotated clinical data. Wendy has provided research operations oversight for commercial laboratories (Caris Life Sciences, Ashion Analytics) and IVD manufacturers (VisionGate, Inc.) as well as at hospital and clinical sites. She has supported medical device product development including device risk classification, pre-clinical testing and design controls and clinical strategy interactions with the FDA.