Experience

Over twenty years supporting Sponsors, CROs, Sites, and IRBs.

Career Overview

Serving as Commercial Central IRB Chair of Univo IRB, an AAHRPP-accredited commercial central IRB, and as a Fellow of the Harvard Medical School Center for Bioethics. Glenwood Ethical Research Advisory was founded to make senior-level IRB and regulatory counsel available to sponsors, CROs, sites, and investigators who need more than a compliance checklist.  In 2024, Cyrus transitioned into executive IRB leadership as Commercial Central IRB Chair at Univo IRB, an AAHRPP-accredited commercial central IRB. He leads board operations, reviewer governance, regulatory review, and service delivery across drug, biologic, and medical device programs, while supporting policy development, reviewer infrastructure, resource planning, and cross-functional coordination. He also represents the organization during FDA inspections, AAHRPP site visits, sponsor audits, and other high-stakes regulatory and quality engagements.

His advisory perspective is grounded in more than 20 years of clinical research experience, nearly a decade in IRB review and leadership, and a fellowship in bioethics through the Harvard Medical School Center for Bioethics. This combination of sponsor, CRO, monitoring, vendor-governance, and commercial IRB experience supports a practical and defensible approach to research oversight, regulatory strategy, and clinical operations.  He has spent more than 20 years across sponsor, CRO, site, monitoring, and IRB executive functions, including six years as a non-affiliated scientific board member at Advarra IRB. His credentials include an MS in Clinical Research, an MBA, and ACRP certifications as a Certified Project Manager, Certified Medical Device Professional, and Certified Clinical Research Associate. He is also a registered nurse with a background in neonatal critical care and emergency medicine, grounding human subject protection review in direct clinical experience. 

Core Areas of Expertise

Domains of active practice.

  • Full-board, expedited, exempt & chair IRB review
  • IRB stipulation & deferral response strategy
  • AAHRPP accreditation & compliance alignment
  • FDA BIMO inspection readiness & 483 response
  • IND / IDE / BLA / NDA / 510(k) / De Novo / HDE / PMA pathways
  • CRO qualification, bid defense & TORO
  • Vendor oversight & quality agreements
  • Informed Consent architecture (21 CFR Part 50)
  • Vulnerable populations (21 CFR Part 50 Subpart D)
  • Belmont Report, Common Rule, HIPAA, GDPR & TCPS2
  • Unanticipated problems, PREs & 21 CFR 312.32 reporting
  • Reviewer recruitment, credentialing & scalability
Education, Certifications & Professional Affiliations

Education

  • Fellowship in Bioethics - Harvard Medical School Center for Bioethics
  • MBA - University of North Carolina Wilmington
  • MS Clinical Research Organization & Management - Drexel University College of Medicine
  • BSN - Western Carolina University
  • Registered Nurse - Multi-Compact State Privileges

Certifications & Professional Memberships

  • Member, Association of Clinical Research Professionals (ACRP) - since 2009
  • Member, PRIM&R - since 2023
  • ACRP Certified Project Manager (CPM)
  • ACRP Certified Medical Device Professional (CMDP)
  • ACRP Certified Clinical Research Associate (CCRA)

Training

  • FDA Regulations
  • HHS (Common Rule)
  • ICH E6 (R3)
  • Health Canada / TCPS2 & PIPEDA
  • Human Research Protection

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