With over 20 years of experience in clinical research program development, project management, and strategy, I am the founder and CEO of Indigo SEA Biotech Solutions LLC, a firm that provides comprehensive and customized solutions for academic institutions, biotech companies, CROs, research sites, and government settings. My mission is to improve the operations and execution of clinical trials with sound strategic planning, analytical approaches, risk mitigation and contingency planning, quality oversight, and process optimization, all in support of the advancement of biotechnology and pharmaceutical development.
As a senior clinical trial research expert, I have led multidisciplinary project teams, worked in various therapeutic areas, including rare disease indications, with vulnerable populations, on trials in all drug development phases, as well as device studies. I have extensive experience in global feasibility, site start-up, regulatory filing, training, writing, budgeting, contracting, vendor management, data safety monitoring, document management/TMF, plan and process development, blinded/unblinded (masked/unmasked) teams, clinical process improvement/change management, and inspection readiness. I leverage my skills and knowledge to provide effective and efficient clinical development strategy, planning, and support for my clients, while ensuring compliance with industry standards and best practices.
Veritux independent consultants are available where you need them – in all major markets and every global region.
