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Laurie Mitchell
President at Criterion Edge
Laurie Mitchell is a highly experienced Master's-prepared Clinical Nurse Specialist with over 20 years of expertise in pharmaceutical and medical device research. Specializing in Medical Writing, Laurie has a proven track record in producing various clinical regulatory documents for both US and OUS regulatory bodies. This includes creating Clinical Evaluation reports (CERs), annual reports, Clinical Study Reports (CSRs), Investigator brochures (IB), Instructions for Use (IFU), Informed Consent Forms (ICF), protocols, and other essential documents. Laurie is well-versed in Common Technical Document (eCTD) and summary submission documents, IND/NDA submissions, and regulatory response documents.