Ms. Drobnes has over 25 years of experience in clinical research and compound development ranging from phase I studies through to successful filing of NDAs. Before serving as an independent consultant to the industry, Claude was the Director of Medical Affairs and Medical Writing at ClinTrials Research, Inc. (Research Triangle, NC), President of CSR Consultants, Inc. (Chapel Hill, NC), Director of Drug Safety Surveillance and Drug Information at Triangle Pharmaceuticals, Inc. (Durham, NC), and Director of Clinical Operations and Drug Safety Surveillance at Trimeris, Inc. (Durham, NC). Historically, She has been leading or providing support to multiple, multinational drug development study teams, including multinational clinical programs, 5 marketed compounds, and numerous Phase I-IIIb studies. Claude has experience with regulatory submissions and interactions with the regulatory agencies both domestic and foreign. She has expertise in medical management for all clinical and safety components of product development. She has expertise in scientific and medical writing supporting clinical trial documentation needs, patient safety narratives, clinical components of NDA, REMS, periodic safety reports, etc. Claude has experience across a broad range of indications, including infectious diseases (HIV/AIDS, hepatitis), cardiovascular (CHF, MI), endocrine and metabolic (hyponatremia, diabetes, obesity, hypercholesterolemia), contraceptive agents, Immunology (rheumatoid arthritis), respiratory (asthma), and renal (ADPKD).