Lucent Clinical Consulting provides human clinical research expertise to medical device and in-vitro diagnostic companies to accelerate commercial launch of new products, ensure compliance to changing regulatory standards and protect core markets through a winning clinical strategy. STRATEGIC CLINICAL CONSULTANT SERVICES: • Define Clinical Program Strategy and Design Clinical Protocols for Medical devices (Class II, Class III, de novo, combination products, humanitarian device exemption) • Design Global Organizations and Grow High-Performing Clinical Teams • Perform Corporate Due Diligence for Clinical-Stage Medical Products • Define Commercialization Pathways for New Technology • Plan Clinical Evidence for New Products (market offense) & Core Products (market defense) • Execute Clinical Risk Management Methodology with Leading Indicators • Evaluate Clinical Quality System Compliance (architecture, audit, SOPs, templates, work instructions, training) CONTACT: • kimberly.oleson.consulting@gmail.com