Date to be announced
Contact us for more infoTRAINING TIMES
Get a practical overview from Study Protocol to Study Report
Functions and importance of data management and biostatistics in clinical trials.
Gain insights into ICH E6 and E3 guidelines, GDPR, and the EU Clinical Trials Regulation applied to clinical studies.
Understand the creation and purpose of TLFs and the structure and statistical basis of the clinical study report.
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.
Learn about the functions of data management, statistical programming, and biostatistics in clinical trials.
Gain insights into ICH E6 and E3, GDPR, and the EU Clinical Trials Regulation, GAMP5 and their applications.
Understand the end-to-end process from study protocol development to the clinical study report.
Understand what data is collected, stored and the role of CDISC standards (CDASH, SDTM, ADaM).
Understand the creation and purpose of TLFs and the structure and statistical basis of the clinical study report.
Apply real-world examples and group discussions to strengthen understanding of biometrics processes.
Designed for professionals who want to enhance their expertise and advance their careers
Biometrics Specialist, Ahrens-Mende Associates
Simone Ahrens-Mende holds a Diploma in Mathematics and a Master’s degree in Clinical Trial Management. She is a highly experienced leader in clinical research, with over 25 years of expertise in Data Management, Statistical Programming, and Biostatistics. Throughout her career, she has held senior positions in international CROs, where she has successfully led cross-functional teams, optimized clinical processes, and ensured compliance with global regulatory standards. Simone is known for her strategic leadership, process innovation, and dedication to quality, having contributed to the success of numerous clinical trials across various therapeutic areas. She brings a unique combination of technical expertise and a strong commitment to mentoring and developing professionals in biometrics and clinical research. We are live on webchat!
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