Digital Quality in Clinical Trials

This course is not currently scheduled but may be offered at your company site.
Please contact Fleming for more information.

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 widespread of digital technologies as well as with the increasing complexity of today’s clinical trials, the unique issues remain especially around clinical trials and the use of electronic systems, artificial intelligence and other digital technologies.

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. Novel approaches to safeguard data integrity and human subjects need to be considered.

This practical course brings the latest EMA & FDA guidelines on the use of digital technologies in clinical trials, industry cases and best practices to mitigate the common technological pitfalls and quality concerns.

Join us in Vienna & learn how you can harness the benefits of digital technologies & ensure the highest regulatory compliance at the same time.

meet the training leaders
Mark Poulton
Executive Director, Former GCP Inspector at MHRA
Poulton Quality Solutions, UK
Willie Muehlhausen
Digital Innovator, Partner
SAFIRA Clinical Research, Ireland
training

Brochure

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

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
key training

Topics

Digital revolution in clinical trials & GCP compliance

Global regulations for electronic systems in clinical trials & DCT projects

eConsent strategy & key considerations for compliance

ePRO requirements, audit targets & inspection observations

EDC requirements & compliance

IRT managed under GCP regulation

EMR systems best practices

eTMF inspection readiness

Audit trails of systems

Audience’s preferred Topic Deep Dive

Benefits of attending

Registration

Training ticket

This course is not currently scheduled but may be offered at your company site.
Please contact Fleming for more information.

Delegate Fee
FROM
2396

Venue

NH Danube City 

Wagramer Str. 21,
1220 Wien, Austria
Phone: +43 1 260200

NH Danube City

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