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Trust & Quality

Certifications & Quality Standards

Independent assessments of Amavita Research's cardiovascular clinical trial operations.

Amavita Research operates under independent quality certifications validated through external assessment. Our certifications are renewed on a defined cadence — most recently with the 2026 IAOCR GCSA recertification awarded on 13 May 2026. Below are the active certifications, the issuing bodies, scope of assessment, and validity periods.

IAOCR GCSA certification shield

2026 IAOCR GCSA Recertification

Awarded 13 May 2026 · Valid through 28 February 2027

Award
GCSA Certification (recertification)
Issuing body
IAOCR — International Accrediting Organization for Clinical Research (iaocr.com)
Award date
13 May 2026
Assessment period
17 February 2026 to 13 May 2026
Standard version
GCSA V5 2024
Lead assessor
Emily Hodgson, IAOCR Certification & Quality Standards Lead
Site location reviewed
Amavita Research Services, LLC, 100 NW 170 Street, Suite 305, North Miami Beach, FL 33169, United States
Renewal date
28 February 2027

Scope — 7 of 7 modules met

  • Governance and Leadership
  • Growth and Strategy
  • Workforce Quality
  • Participant Engagement
  • Feasibility
  • Study Start-Up and Initiation
  • Study Management Operations and Close Down

Areas exceeding standards (2026 assessment)

Quoted directly from the IAOCR assessor's 2026 report.

"A strong commitment to positive participant experiences is evident across the organisation, with staff demonstrating a clear understanding of how this is supported through site procedures and workplace culture."
"A clear and well-defined focus on business development for 2026 is evident. Notable progress has been achieved through the appointment of a new Principal Investigator with expertise in a new therapeutic area (electrophysiology) and access to a new patient population, strengthening the organisation's clinical capabilities and expanding its research offering. In addition, the appointment of a new Head of Growth and Strategy further reinforces the organisation's capacity to deliver its development objectives."

WPQC Gold Certification

Amavita Research also holds the IAOCR Workforce Professional Quality Credential (WPQC) Gold certification, also renewed on the 28 February 2027 cadence. WPQC Gold validates that clinical research workforce roles, training, and competencies meet IAOCR's professional quality standards.

ICH-GCP E6(R3) Compliance

Amavita Research SOPs and operations are compliant with the International Council for Harmonisation Good Clinical Practice guideline E6(R3) — the global standard for the design, conduct, and reporting of clinical trials.

SCRS Membership

Amavita Research is a member of the Society for Clinical Research Sites (SCRS) — the global trade association representing clinical trial sites and advocating for industry quality standards.

Inspection History

Zero FDA Form 483 findings to date. Amavita Research maintains audit-ready SOPs, internal QA review, and structured CAPA processes documented in SOP SITE-103 and SITE-107.

About IAOCR GCSA

The Global Clinical Site Assessment (GCSA) is the global quality standard for clinical research sites, developed by IAOCR in consultation with sponsors, CROs, public health trial sites, and government organizations. GCSA certification assures sponsors and CROs of a site's capability, validated through independent assessment against sponsor-defined global quality standards across 7 critical business operational areas.