Summary

This course provides in-depth knowledge of quality assurance for digital systems used in clinical trials. Participants will have the opportunity to discuss digitalisation-related opportunities and challenges with peers, representatives from the Danish Medicines Agency, and experienced pharma professionals with hands-on expertise.

The increasing use of digital tools enables innovative approaches to data management and clinical trial design. Throughout the course, you will gain practical insights into managing data securely and reliably in compliance with current regulatory requirements and guidelines, including ICH GCP E6 (R3) and EMA guidelines.

As many sponsors rely on outsourced or vendor-provided digital solutions, the course will also address relevant requirements and sponsor responsibilities for system validation and oversight.

You will strengthen your understanding of quality requirements, data integrity, and secure data management in a digital clinical trial environment.

Before the course, you are invited to submit specific questions or cases for discussion. The programme is case-based and highly interactive, and we encourage active participation to ensure relevant and valuable discussions.

Keywords

Digital tools in clinical trials
Quality assurance
ICH E6 (R3)
Validation
DCT

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Course leader & lecturers

Alan Yeomans
Course leader
Consultant
Atrium
Lisbeth Bregnhøj
Lecturer
GCP Inspector
Danish Medicines Agency
Berit Gorsøe Kjeldsen
Lecturer
Senior Project Manager
Klifo A/S

See all

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Is this course for you?

This course is for you if you work as a sponsor, a clinical research associate, CRA, an on-site monitor, a clinical trial manager, a clinical project manager, a site selection, or an oversight staff associate.

It will also be relevant if you are a site staff professional, a principal investigator, a study coordinator, or a GCP compliance officer.

Others who will benefit include professionals working with quality assurance or project management in clinical drug trials, e.g., Trial Nation and IT professionals responsible for digital systems in regions, CROs, or at suppliers of digital systems

What you will learn

An understanding of investigator and sponsor responsibilities related to the management, quality assurance, and validation of digital systems in clinical research
Insight into applicable regulatory requirements and how to interpret and implement them in practice
An understanding of the Danish Medicines Agency’s expectations regarding the use of digital systems in clinical research
Knowledge of the required documentation and the level of oversight expected from sponsors when system validation is performed by vendors

What your company will get

An employee who understands investigator and sponsor responsibilities for quality assurance of digital systems in clinical research
An employee with knowledge of applicable regulations and the ability to apply them in practice
An employee who understands the Danish Medicines Agency’s expectations regarding the use of digital systems in clinical research
An employee with a solid understanding of validation, including the documentation and oversight required from the sponsor when validation is performed by a vendor

Course calendar

26 Nov 2026 9:00-16:00

Day 1

Digitalisation of clinical trials and quality
Regulatory Requirements: ICH GCP and EMA guidelines
Requirements for digital systems and tools
Quality Assurance: What does it mean in practice?
Oversight and documentation
Archiving
Inspection and lessons learned

Practical information

Registration

Registration deadline
19 Nov 2026

Atrium
Lersø Parkallé 101
2100 København Ø

Attend on location (7,000 DKK)

Attend online (0 DKK)

Register

26 Nov

Please note: The programme structure may be subject to minor adjustments

Course information

Literature

Prior to the course, you will be given access to mandatory readings via your personal Atrium log-in, including the following:

Interpretation and Application of ICH E6(R3): Good Clinical Practice Guideline

Module 1: Introduction and Foundational Concepts, published in October 2025

Module 2: Responsibilities and Oversight (coming soon)

Module 3: Data Governance (coming soon)

Module 4: Informed Consent, published in January 2026

Module 5: Essential Records (coming soon) ICH E6(R3) Module 1.1

Examination

There is no examination for this course.

Want to know more or need help?

Contact Client Manager Louise V. Petersen at +45 40 44 99 43

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Management and Oversight of Digital Tools in Clinical Research