Summary
This 3-day training provides a structured overview of Biometrics in Clinical Trials, focusing on data management, statistical programming, and the use of eClinical systems within the EU framework. Participants will gain insights into key regulatory guidelines, including ICH E6, ICH E3, GDPR, and EU Clinical Trials Regulation, and understand their application in clinical research. The course explores the process from study protocol to study report, with an emphasis on CDISC standards, data collection processes, and the validation of eClinical systems. Through interactive discussions and practical examples, attendees will develop a solid understanding of the biometrics lifecycle and its critical role in clinical trials.
Learning Objectives
- Understand the Role of Biometrics
- Navigate through Key Regulatory Frameworks
- Explore the Study Lifecycle
- Learn about Data Collection and Standards
- Discover Statistical Outputs and Reporting
- Build Practical Understanding
Key Topics
- Biometrics History and Regulatory Foundations
- ICH E6 and Data Integrity
- Clinical Study Report (CSR) Structure
- Types of Data and Best Practices in Reporting
- Overview of eClinical Systems
- CDISC Standards in Biometrics
- Clinical Data Management Processes
- Biostatistics and Statistical Programming
- Types of Statistical Tests in Clinical Trials
- Early phase: Pharmacokinetics (PK)
- FDA and EMA Guidelines
Who should attend?
This training is designed for professionals involved in clinical research, including:
- Clinical Trial Managers
- Project Managers
- Data Managers
- Statistical Programmers
- Biostatisticians
- Regulatory Affairs Specialists
Our online training experience includes
- Our client zone – a single source for all training materials as well as pre and post-training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Digital and LinkedIn certificates
Trainers
Biometrics in Clinical Trials
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
