プロフィール詳細

プロジェクトを作成

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Dr. Verónica R.に依頼

Argentina

Nephrologist & Clinical Researcher | Statistical Analysis in R | Regulatory Affairs (ANMAT)

プロフィール概要

I am a nephrologist and internal medicine physician with 16 years of clinical experience, specializing in renal transplantation and glomerulopathies. I currently hold a dual role as a Clinical Trial Evaluator at ANMAT (Argentina's national regulatory authority) and as a nephrologist at Fundación Favaloro, Hospital Alemán, and Hospital Ramos Mejía. My work at ANMAT involves formal scientific and GCP review of clinical trial protocols across therapeutic areas, including nephrology, oncology, and immunology — with direct application of ICH E2A, ICH E6, and local Argentine regulatory frameworks. I have extensive experience drafting formal protocol observations and evaluating study designs for methodological soundness, ethical compliance, and statistical validity. On the research and data side, I hold a postgraduate diploma in Statistics for Observational Studies in R (Universidad Favaloro) and have applied this training to an active prospective AKI/AKD registry (n≈400) at Hospital Ramos Mejía, including data architecture, pseudoanonymization, and a planned analytical pipeline using clustering and logistic regression. I also completed pharmacovigilance training at the Uppsala Monitoring Centre (UMC). I offer services in: - Scientific peer review and manuscript critique (nephrology, internal medicine, clinical trials, observational studies) - Statistical analysis and methodology review (study design, Tabla 1, regression, survival analysis) in R - Clinical protocol review and regulatory feasibility assessment - Medical writing and content accuracy review I work in English and Spanish. Available for fixed-fee or hourly freelance projects.

専門分野

• ★ Biostatistics
• ★ R
• ★ Urology & Nephrology
• ☆ Clinical Trials
• ☆ Clinical Trials Data Analysis
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Dialysis
• ☆ Peer Review
• ☆ Regulatory Writing
• ☆ Medical Writing
• ☆ Medical Content Writing
• ☆ Patient Education Materials
• ☆ Research Summaries & Abstracts
• ☆ Investigational New Drug (IND) Application Writing

サービス

• Writing
• Data & AI

Writing Medical Writing, Translation

Data & AI Predictive Modeling, Statistical Analysis, Data Visualization

職務経験

Clinical Trial Evaluator

ANMAT: Administración Nacional de Medicamentos, Alimentos y Tecnología Médica

12月 2024 - 現在

Nephrologist: Renal Transplant Unit

Fundación Favaloro

9月 2024 - 現在

Nephrologist

Hospital Alemán

6月 2023 - 現在

Nephrologist: Clinical Researcher

Hospital Ramos Mejía

6月 2023 - 現在

学歴

Diploma in Artificial Intelligence Applied to Health

FISP : Universidad de Buenos Aires

3月 2026 - 8月 2026

Postgraduate Diploma in Statistics for Observational Studies

Universidad Favaloro

3月 2025 - 12月 2025

Nephrologist

CEMIC

6月 2020 - 6月 2023

Doctor of Medicine (MD)

Universidad Nacional de la Plata

3月 2008 - 3月 2013

認定資格

• Pharmacovigilance Training Program

  Uppsala Monitoring Centre (UMC)

  3月 2026 - 現在

• Good Clinical Practice (GCP) ICH E6

  Global Health Training Centre

  3月 2026 - 現在

出版物

JOURNAL ARTICLE

Veronica Roatta (2023). Access to treatment in chronic kidney disease, dialysis and transplantation. Is there gender equality? . Frontiers.

Veronica Roatta (2023). Prevalencia de Hiperkalemia, factores de riesgo asociados y morbimortalidad en pacientes en Hemodiálisis . Revista de Nefrología, Diálisis y Trasplante.