プロフィール詳細

プロジェクトを作成

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Gevorg Y.に依頼

Canada

Independent Clinical Research & Evidence Synthesis Consultant | CRA • TMF Oversight • Systematic Reviews

プロフィール概要

I’m an independent Evidence Synthesis and Clinical Research Consultant with over 15 years of combined academic and clinical research experience, including 6 years as a Clinical Research Associate (CRA) supporting global Phase I–III trials. Trained in public health, I bridge clinical operations experience with evidence generation and scientific writing to deliver high-quality, policy-relevant outputs. I specialize in systematic and targeted literature reviews (PRISMA methodology), meta-analyses, and HTA-aligned evidence packages for global market access and reimbursement submissions. My clinical background adds an operational perspective to every project — ensuring that evidence synthesis reflects real-world trial design, execution, and data integrity. Core competencies: • Systematic & targeted literature reviews (SLR/TLR) compliant with PRISMA standards • Meta-analysis and qualitative/quantitative evidence synthesis • HTA-aligned summaries, value dossiers, and reimbursement submissions • Medical and regulatory writing — CSRs, protocols, IBs, and ICFs • TMF/ISF inspection-readiness support and CRA documentation QC • Data extraction and reference management (Covidence, EndNote, Rayyan) I collaborate remotely with sponsors, CROs, and evidence vendors to produce transparent, reproducible, and inspection-ready deliverables that meet HTA and regulatory expectations (NICE, CADTH, EMA, FDA). Whether you need a full systematic review, an HTA evidence package, or documentation support from an experienced CRA perspective — I provide tailored, compliant, and publication-ready results.

専門分野

• ☆ Statistics
• ☆ Meta-Analysis
• ☆ Clinical Trials
• ☆ IRB Applications
• ☆ Clinical Trial Design
• ☆ Clinical Data Management
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Clinical Trials Data Analysis
• ☆ Health Technology Assessment
• ☆ Regulatory Affairs
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Medical Device Literature Reviews
• ☆ Medical Writing
• ☆ SEO Medical Writing
• ☆ Healthcare Communications
• ☆ Patient Education Materials
• ☆ Research Summaries & Abstracts
• ☆ Cochrane Reviews
• ☆ Literature Review
• ☆ Systematic Literature Review

サービス

• Writing
• Research
• Consulting
• Data & AI

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing

Research Meta-Research, Gray Literature Search, Scientific and Technical Research, Systematic Literature Review

Consulting Healthcare Consulting, Scientific and Technical Consulting, Regulatory Consulting

Data & AI Statistical Analysis, Data Visualization, Text Mining & Analytics, Data Cleaning

職務経験

Senior Clinical Research Associate

ClinChoice

1月 2020 - 6月 2023

Clinical Research Associate consultant

ClinChoice

1月 2020 - 6月 2023

Research Coordinator

Cancer Care Ontario Ontario Health

10月 2018 - 12月 2019

Research Analysts

Centre for Addiction and Mental Health (CAMH)

8月 2017 - 8月 2018

Academic Support Research Assistant

Joseph's Healthcare Hamilton

8月 2013 - 4月 2014

学歴

Certified Clinical Research Associate

McMaster University

5月 2013 - 10月 2014

Master of Public Health

American University of Armenia

8月 2007 - 10月 2009

認定資格

• GCP for Clinical Trials with Investigational Drugs and Biologics

  CITI Rid xxxxxxxx

  4月 2025 - 現在