Stacie Wehling, MSCR, RAC-US

Stacie provides regulatory, clinical, quality, and scientific consulting services to the pharmaceutical industry.  She is a clinical research professional with a strong understanding of the role of clinical testing to support marketing approval.  She has experience in all phases of clinical research, Phase 1 through Phase 4, and start-up to close-out.  She has managed global studies, both pediatric and adult.  Stacie has worked in various therapeutic areas including brain injury, cystic fibrosis, diabetes, ophthalmology, cardiovascular, oncology, respiratory, infectious, and autoimmune diseases.  She has led or provided strategic medical writing contributions for the preparation of numerous pre-meeting packages, Investigational New Drug (IND) Applications, New Drug Applications (NDA), and Biologics License Applications (BLA).  She has experience performing clinical quality assurance functions and has completed client audits of contract research organizations (CROs), Phase 1 units, clinical investigational sites, and trial master files.  She has prepared and maintained standard operating procedures (SOPs) and guidelines pertinent to the industry, client, and therapeutic area.  Stacie has an M.S. in Clinical Research from Campbell University and a B.S. in BioMedical Science with a minor in Chemistry from Averett University.  She maintains Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society (RAPS).