Biography

Eli Alcantar Aguilar is an accomplished clinical research leader and Regulatory Affairs and governance strategist with more than 10 years of experience supporting the development, oversight, and execution of clinical trials across academic health systems, contract research organizations (CROs), and global pharmaceutical sponsors. She holds a background Biochemistry from Arizona State University’s School of Molecular Sciences and Spanish Linguistics from Arizona State University’s School of Liberal Arts and Sciences. Throughout her career, Eli has served in progressively advanced roles including Global Clinical Trial Manager, Regulatory Affairs Manager, Clinical Research Consultant, Clinical Trial Manager II, and Industry Sponsor Transfer of Regulatory Obligations Delegate. She has led complex multi-center and multinational oncology and rare disease studies, managed large-scale clinical operations involving hundreds of sites and research personnel, and supported regulatory submissions to the FDA, IRBs, and global health authorities. Her expertise spans regulatory affairs, project management, risk-based quality management, CRA and vendor sourcing, compliance oversight, study activation, protocol lifecycle management, and operational excellence. Recognized as an Exceptional Performer, Eli is dedicated to protecting research participants, ensuring regulatory compliance, advancing equitable access to clinical research, and accelerating the delivery of innovative therapies to patients. She also maintains advanced project management expertise, including Project Management Professional (PMP®) and PMI-aligned project management methodologies, bringing strategic governance, resource optimization, and risk mitigation practices to research operations and regulatory pathways.

Eli has supported clinical research programs across a broad range of therapeutic areas, including:

  • Gynecologic Cancers
  • Ovarian Cancer
  • Endometrial Cancer
  • Cervical Cancer
  • Solid Tumor Oncology
  • Hematologic Malignancies
  • Rare Diseases
  • Investigational Oncology Therapies
  • Early-Phase Clinical Research (First-in-Human Studies)
  • Bioequivalence and Bioavailability Research
  • Cardiovascular Safety Studies (TQT)
  • Precision Medicine and Translational Research
  • Industry-Sponsored and Investigator-Initiated Research Programs

Eli’s research and regulatory strategy is centered on strengthening clinical research operations while improving patient access to innovative therapies through compliant, efficient, and data-driven approaches. Through this work, Eli aims to support HonorHealth Research Institute further strengthen its reputation as a national leader in clinical research while ensuring patients have safe, equitable, and timely access to groundbreaking therapies and clinical trial opportunities.

 

 

Research Interests & Focus

Eli’s professional interests focus on advancing clinical research infrastructure and regulatory strategies that improve patient access, study quality, and operational efficiency. Her areas of interest include:

  • Gynecologic Oncology clinical research
  • Oncology drug development and translational medicine
  • Biologics and Biotechnology research
  • Regulatory science and compliance innovation
  • FDA regulatory pathways and expanded access (compassionate use) programs
  • Risk-based monitoring and risk-based quality management
  • Clinical trial governance and oversight
  • Sponsor oversight and transfer of regulatory obligations
  • Decentralized and hybrid clinical trial models
  • Clinical operations optimization and project management
  • Health equity and reduction of disparities in clinical research participation
  • Research informatics, automation, and clinical trial systems integration
  • Global regulatory strategy and submission management
  • Quality systems development and continuous process improvement

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