President/Founder
Clinical Outcome, Llc. Practical, Fact Based Ai Driven Healthcare
March 2013 - currentClinical Outcome, llc.President• Create Effectiveness Studies, part of the FDA Level 3 Efficacy Studies for pharmaceuticals, pharmacogenetics, devices and toxicology. • Develop compliant marketing materials, websites, secure server and credentialing process.• Manages daily activity for data retrieval, logistics, compliance (COI, ICH GCP E6, HIGHTECH Act).• Contracting board-certified physicians to write protocols and gain IRB approvals. • Adeptly compile daily study data through secure (HIPPA Compliant) web-based portals for analysis. • Create workflows, database security protocol, operational infrastructure, uniform reporting procedures and onboarding process for Subjects and Study Coordinators, as approved in study protocols. • Recruiting medical sales reps and medical marketing organizations to refer Study Coordinators.• Recruiting and oversee Chief Medical Officers for each study to bring expertise in defining study topics and market, overseeing all medical aspects of the studies and working with Independent Review Boards.