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Introduction to Clinical Trials: Understand the
phases, design, and ethical considerations.
Data Collection & Management: Learn about clinical
databases, data integrity, and standardization.
Statistical Analysis: Apply statistical models and
biostatistics to analyze trial results.
Regulatory & Compliance Reporting: Learn about FDA,
EMA, and ICH guidelines.
Clinical Trial Case Studies: Examine real-world
applications and case reports.
From Learning to Leading.
Clinical Trial Analysis & Reporting: Turning Data into Insights
Gain expertise in analyzing clinical trials, regulatory reporting, and data interpretation for pharmaceutical research.
What you'll learn
Develop a deep understanding of clinical trial processes, statistical analysis, and regulatory compliance in pharmaceutical research.
This course is ideal for clinical researchers, data analysts, and professionals in the pharmaceutical industry.
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Course Content
- Overview of clinical trial phases
- Trial design and methodologies
- Ethical considerations and participant safety
- Statistical methods in clinical trials
- Handling missing data and biases
- Interpreting trial outcomes
- FDA, EMA, and ICH regulatory guidelines
- Clinical trial documentation and reporting
- Ethical and legal considerations
Requirements
- Basic understanding of clinical research
- Familiarity with statistical concepts
- Interest in regulatory and compliance aspects
Description
- Learn clinical trial methodologies
- Master statistical analysis and data interpretation
- Understand regulatory compliance requirements
- Apply case studies for practical knowledge
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