Areas of Expertise:
Stacie Wehling, MSCR, RAC-US
Stacie provides regulatory, clinical, and quality support to pharmaceutical clients. 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 in both pediatric and healthy and patient adult populations. She has authored and reviewed various clinical and regulatory documents and managed lifecycle development and regulatory affairs of numerous INDs and orphan drug designation requests. Stacie has experience performing quality assurance functions and has completed client audits to qualify clinical sites, contract research organizations, and other clinical vendors. She has also prepared clinical sites for FDA audits and prepared and maintained standard operating procedures 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).