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  • Pharma
  • Training Courses | ClassroomTraining

Digital Quality in Clinical Trials

  • 22 – 23 April 2026
  • Vienna, Austria
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Digital Quality in Clinical Trials

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Training features

Interactive discussions and Q&A sessions
Individual discussion & consultancy with the trainer

Case studies from the trainer's experience
Certificate of completion issued by the trainer
Comprehensive course documentation

Course description

With the increasing complexity of today’s clinical trials, as well as the speed of technological innovation and AI tools utilization, unique issues remain especially around clinical trials and the use of electronic systems.

Understanding regulations – particularly the principles and intent of those regulations – and being able to apply them to new technology and processes in clinical trials, is critical to a company’s success. With the update to ICH E6(R3) there is an even greater emphasis on electronic data capture and the use of computerized systems in clinical trials; Data governance has been given a whole section to itself.

This unique course provides a practical & in-depth understanding of electronic systems and technologies used in clinical trials, and brings clarifications on global regulation, requirements, compliance & quality concerns.

Join us in Vienna & learn how a company can actively enable digital innovation in clinical trials & ensure the highest regulatory compliance at the same time.

meet the training leaders
Rebecca Stanbrook | Speaker | Fleming
Linkedin
Rebecca Stanbrook
GCP Expert
Switzerland
View trainer bio
Willie Muehlhausen | Fleming
Linkedin
Willie Muehlhausen
Partner, Digital Innovator
SAFIRA Clinical Research, Ireland
View trainer bio
training

Brochure

Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!

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Digital Quality in Clinical Trials training organized by Fleming_Agenda Cover
Digital Quality in Clinical Trials training organized by Fleming_Agenda Cover
Digital Quality in Clinical Trials training organized by Fleming_Agenda Cover

Who Should Attend

The Digital Quality in Clinical Trials training is designed for professionals involved in clinical quality, data management, compliance, and digital systems across pharma, biotech, and CRO organizations.

It is ideal for:

  • Clinical QA and GCP Compliance Professionals
  • Clinical Auditors and Quality Managers
  • Clinical Operations and Project Managers
  • Clinical Data Managers and Data Scientists
  • eClinical, eTMF, and Digital Trials Specialists
  • Clinical Quality Oversight and CAPA Managers
  • Medical Quality and R&D Quality Professionals
  • Clinical Process and Vendor Managers
  • Professionals working with ePRO, eConsent, EDC, or IRT systems
 

This course is especially valuable for teams responsible for GCP inspection readiness, digital system validation, data integrity, and compliance with ICH E6 (R3).

key training

Topics

Digital revolution in clinical trials & GCP compliance

Global regulations for electronic systems in clinical trials & the use of decentralised elements in clinical trials

ICH E6(R3) – key updates & their impact

Data integrity requirements

eConsent strategy

Audit targets & inspection observations from digital trials (hybrid, decentralized or remote)

Main electronic systems – requirements & best practices

Providers of systems – issues to be aware of

Audit trails of systems

Benefits of attending

  • Get critical insights into electronic systems used in clinical trials
  • Understand the interpretation of FDA & EMA guidelines related to electronic systems in clinical trials
  • Explore pros and cons of the use of DCT (Decentralized Clinical Trials) elements and the usage of Artificial Intelligence and Machine Learning in Clinical Trials
  • Gain clarification on requirements & audit targets related to eCOA systems
  • Explore data integrity requirements & best practices to handle data integrity issues
  • Learn about the essential documents, technology & other requirements for eTMF
  • Deep dive into the main electronic systems compliance challenges
  • Explore requirements on data ownership, metadata & structured data in electronic systems
  • Work on electronic data issues
  • Understand how to handle eConsent requirements & issues
  • Gain key considerations for audit trail of systems and analysis
  • Learn how to overcome the main issues with the providers of systems
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Training ticket

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Contact us

Andrea Weber | Marketing Manager | Fleming
Linkedin
Andrea Weber
Sr. Manager for Pharma
Phone: +421 257 272 100
Email: event.inquiries@fleming.events

FAQs – Digital Quality in Clinical Trials

ICH E6 (R3) is the latest update of the International Council for Harmonisation’s global standard for Good Clinical Practice (GCP) in clinical trials. It focuses on risk-based approaches, quality by design, and the use of technology to promote flexibility and innovation. The training helps sponsors and CROs understand what regulators such as EMA, MHRA, and FDA expect under this new version.

Digital systems such as eConsent, ePRO, IRT, EMS, and eTMF are now part of almost every trial. Ensuring digital quality helps keep data accurate, secure, and compliant with GCP. This training explains how to manage and validate these systems effectively.

Regulatory inspections often identify issues such as poor system validation, missing audit trails, and weak data integrity controls. The training shares real inspection examples from EMA, MHRA, and FDA and explains how to avoid these findings.

The course is ideal for professionals in GCP, QA, Clinical Operations, Data Management, and Digital Systems. It is especially useful for auditors, quality managers, clinical project managers, and digital transformation teams in pharma, biotech, and CROs.

Previous editions of this course were attended by teams from Sanofi, Chiesi, BioNTech, Novo Nordisk, UCB, Polpharma, Galapagos, Boehringer Ingelheim, Octapharma, and many others.

You will learn how to meet ICH E6 (R3) requirements, prepare for GCP inspections, and ensure data integrity in digital and decentralized trials. The sessions are led by a former MHRA Group Manager and a Digital Clinical Trials Innovator.

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