Ivette Piloto is a highly accomplished Clinical Research Professional with more than 25 years of experience managing Phase I-IV clinical trials across a wide range of therapeutic areas, including cardiovascular, nephrology, endocrinology, infectious disease, pulmonology, gastroenterology, neurology, psychiatry, vaccines, dermatology, obesity, and rare diseases. She currently serves as Lead Clinical Research Coordinator at NewGen Health Group, where she oversees study operations, patient enrollment, regulatory compliance, and sponsor interactions. 

Throughout her distinguished career, Ms. Piloto has held leadership positions including Site Manager, Study Manager, Site Director, Senior Clinical Research Coordinator, Quality Assurance Specialist, Regulatory Specialist, and Data Specialist. Her extensive operational expertise spans study startup, decentralized clinical trials, patient recruitment, regulatory management, laboratory operations, PBMC processing, quality control, budgets and contracts, and site management. 

Having successfully supported hundreds of clinical trials sponsored by leading pharmaceutical companies including AstraZeneca, Pfizer, Eli Lilly, Bristol Myers Squibb, Merck, GSK, Novartis, Takeda, Amgen, AbbVie, Vertex, Boehringer Ingelheim, and many others, Ms. Piloto brings exceptional knowledge of sponsor expectations, protocol execution, and regulatory compliance. Her ability to drive enrollment, maintain data quality, and ensure successful study delivery has made her a trusted partner for sponsors and CROs alike. 

Ms. Piloto’s extensive experience in both traditional and decentralized clinical trials, combined with her expertise in patient recruitment and retention strategies, enables NewGen Health Group to consistently deliver high-quality data, operational excellence, and strong enrollment performance across diverse therapeutic areas. 

• 25+ years of clinical research experience.
• Extensive Phase I-IV and decentralized clinical trial expertise.
• Proven success managing complex, multi-specialty research programs.
• Experienced in study startup, regulatory affairs, budgets, and contracts.
• Strong patient recruitment, retention, and enrollment performance.
• Expertise in PBMC processing, laboratory operations, and biospecimen management.
• Quality-focused approach with extensive QA/QC experience.
• Deep sponsor and CRO collaboration experience.
• Skilled in managing high-volume studies while maintaining protocol compliance.
• Experience across cardiovascular, nephrology, endocrinology, pulmonology, psychiatry, neurology, obesity, vaccines, infectious disease, dermatology, and gastroenterology trials.