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
GCP Expert
Switzerland
Willie Muehlhausen
Partner, Digital Innovator
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 & 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

Registration

Training ticket

Delegate Fee
FROM
2396

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