プロフィール詳細

プロジェクトを作成

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Viktoria K.に依頼

Ireland

Idependent Clinical Study Protocol Reviewer and Specialist with 14 years in depth experience in clinical research| Coach

プロフィール概要

I am an independent clinical research professional with 14 years experiences in the sector. My expert area is clinical trial protocol content review and development, as through my career I read and analyzed and work with more than 300 different clinical study protocols in different phases, designs, and indications, so I can see challenges in the document what others might not see. I have worked on platform, umbrella, and basket adaptive trial designs in various oncology indications. I support pharmaceutical companies and clinical study protocol writers to create easy-to-read, easy-to-use, technically improved clinical study protocols. I am so passionate about clinical research by leveraging pharmaceutical, clinical research, healthtech, medtech, regulatory, and engineering knowledge with critical and analytical thinking. As I have an entrepreneur mindset, and I am a visionary and keen to help individual researchers and companies to bring their idea to next level. I am also a coach and mentor, helping individuals to be better with every day.

専門分野

• ☆ Environmental Engineering and Technology
• ☆ Data Collection
• ☆ Environmental Science
• ☆ Environmental Management & Protection
• ☆ Renewable Energy
• ☆ Solar Energy
• ☆ Knowledge Management
• ☆ Information & Knowledge Management
• ☆ Drug Development
• ☆ Small Molecule Drug Development
• ☆ Biologic & Biosimilar Development
• ☆ Preclinical ADME/PK/PD
• ☆ Drug-Drug Interactions
• ☆ Preclinical Research
• ☆ Preclinical Pharmacology
• ☆ Investigational New Drug (IND) Application Consulting
• ☆ Drug Efficacy Testing
• ☆ Bioavailability
• ☆ Vaccine Development
• ☆ Pharmaceutical Manufacturing
• ☆ Bioprocess Development
• ☆ Small Molecule Manufacturing
• ☆ Biologic & Biosimilar Manufacturing
• ☆ Medical Devices
• ☆ Medical Device Development
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ Clinical Trials
• ☆ IRB Applications
• ☆ Clinical Trial Design
• ☆ Patient Recruitment
• ☆ Clinical Data Management
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Clinical Trials Data Analysis
• ☆ Women's Health
• ☆ Breast Cancer
• ☆ Ovarian Cancer
• ☆ Oncology
• ☆ Radiation Therapy
• ☆ Chemotherapy
• ☆ Precision Medicine
• ☆ Gastroenterology & Hepatology
• ☆ Colorectal Cancer
• ☆ Pancreatic Cancer
• ☆ Stomach & Esophageal Cancer
• ☆ Liver Cancer
• ☆ Endocrinology
• ☆ Diabetes
• ☆ Hematology
• ☆ Hematology-Oncology
• ☆ Leukemia & Lymphoma
• ☆ Infectious Disease
• ☆ Viral Diseases
• ☆ COVID-19
• ☆ Cardiovascular Disease
• ☆ Vascular Medicine
• ☆ Immunotherapy
• ☆ Gene Therapy
• ☆ Pharmaceutical Management
• ☆ Pharmaceutical Technology
• ☆ Metabolism & Metabolic Disease

サービス

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Technical Writing

Research Market Research, Feasibility Study, Gap Analysis, Systematic Literature Review

Consulting Scientific and Technical Consulting, Regulatory Consulting

Data & AI Data Insights

Product Development Product Evaluation, Product Validation, Concept Development, Prototyping

職務経験

Founder, Director

KomCoord Ltd

7月 2021 - 現在

Lead CTSME

ICON, Plc

8月 2014 - 6月 2021

Senior CRA

Medpace

2月 2012 - 7月 2014

CRA

Assign Hungary Kft

10月 2010 - 1月 2012

Clinical Research Coordinator

CRC Hungary Kft

3月 2008 - 9月 2010

Associate Research Fellow

Hungarian Academy of Sciences

9月 2000 - 2月 2008

学歴

Environmental Enineering - M.Sc

University of Pannonia - Hungary

9月 1995 - 6月 2000

認定資格

• GCP certificate

  NIDA Clinical Trials Network

  1月 2022 - 現在

• Certified Associate in Project Management

  Project Management Institute

  1月 2016 - 現在