Clinical, Research and Clinical ComplianceJan Dugas, BA, CQA is a Clinical Research and Clinical Compliance Consultant for DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. Jan has extensive expertise managing multi-center national & international clinical studies including all components of clinical research from protocol development through commercial regulatory approval. Jan has over 30 years of experience working in FDA and international regulated industries.
Ms. Dugas began her clinical research career working as a clinical site coordinator to her most recent roles as interim VP of Clinical, Regulatory and Quality. Her experience spans from small start-ups to large international corporations for Medical Device such as; Medtronic, Cardiovascular System, EnteroMedics, Terumo CardioVascular, Coloplast, Neuros Medical, Respithera. Pharmaceutical companies such as: Alexion Pharmaceuticals, Lexicon, Axovant, Mallinckrodt, Algorithme. She has delivered successful clinical trials and obtained national and global clinical trial approvals (FDA, EU, MHLW, TGA) for programs such as; DBS for Advanced Parkinson’s Disease, Essential Tremor, Spinal Cord Stimulation, Vagal Nerve Blocking Systems, Atherectomy Systems and more.
In addition, she has developed clinical compliance and clinical operations organizations for medical device and pharmaceutical companies and implemented global regulatory policies and procedures, auditing and monitoring programs.
Jan cultivates relationships with various stakeholders including FDA division and branch managers, business leaders, board members, physicians, and international regulatory agents by being respectful, approachable, and genuine. Her experience includes products in many disciplines including but not limited to: Cardiology, Diabetes, Gastroenterology, Nephrology, Neurology, Obesity, Pain, Pulmonary/ Respiratory, Transplant and Urology with Adult/Pediatrics/Geriatrics clinical trial experience.
She brings calm to chaos in high pressure, high urgency, high stakes situations and is known as a change agent who is comfortable with the ambiguity of a start-up, as well as the complexity of an international corporation. Valued as a loyal team member and dedicated to successful results. Most of all, Jan is passionate about improving people’s quality of life.
Jan graduated from Bethesda Nursing School and Bethel University for business management, with honors in both programs.