Biometrics in Clinical Trials
6 – 8 October 2025
1850 €
TRAINING TIMES
14:00 - 18:00 Vienna
13:00 - 17:00 London
08:00 - 12:00 New York
05:00 - 09:00 Los Angeles
WHY SHOULD YOU ATTEND?
Get a structured overview of Biometrics in Clinical Trials
Get a practical overview from Study Protocol to Study Report
Data management, statistical programming and eClinical systems
Functions and importance of data management and biostatistics in clinical trials.
Navigate Key Regulatory Frameworks
Gain insights into ICH E6 and E3 guidelines, GDPR, and the EU Clinical Trials Regulation applied to clinical studies.
Discover Statistical Outputs and Reporting
Understand the creation and purpose of TLFs and the structure and statistical basis of the clinical study report.
OUR ONLINE TRAINING EXERIENCE INCLUDE
Two days of expert-led Zoom sessions packed with discussions, Q&As, and real-world scenarios.
All slides, tools, and supporting materials available in our CLIENT ZONE before, during, and after the course.
Receive a digital certificate (also Linkedin-ready) that verifies your skills in strategic trial planning.
LEARNING OBJECTIVES
Understand the Role of Biometrics
Learn about the functions of data management, statistical programming, and biostatistics in clinical trials.
Navigate Key Regulatory Frameworks
Gain insights into ICH E6 and E3, GDPR, and the EU Clinical Trials Regulation, GAMP5 and their applications.
Explore the Study Lifecycle
Understand the end-to-end process from study protocol development to the clinical study report.
Learn Data Collection and Standards
Understand what data is collected, stored and the role of CDISC standards (CDASH, SDTM, ADaM).
Discover Statistical Outputs and Reporting
Understand the creation and purpose of TLFs and the structure and statistical basis of the clinical study report.
Build Practical Understanding
Apply real-world examples and group discussions to strengthen understanding of biometrics processes.
WHO IS THIS TRAINING FOR?
Clinical Trial Managers
Data Managers
Statistical Programmers
Biostatisticians
Project Managers
Regulatory Affairs Specialists
Clinical Data Managers
Biometric systems specialists
KEY TOPICS
Biometrics History and Regulatory Foundations
Clinical Study Report (CSR) Structure
ICH E6 and Data Integrity
CDISC Standards in Biometrics
Biostatistics and Statistical Programming
Clinical Data Management Processes
Types of data and Best Practices in Reporting
Overview of eClinical Systems
FDA and EMA Guidelines
Early phase: Pharmacokinetics (PK)
TRAINER
PAST PARTICIPANTS
Biometrics in Clinical Trials: A Practical Overview from Study Protocol to Study Report
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
