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AI & ML in Clinical Trials: Fundamentals, Applications, and Regulatory Aspects Training Course

AI and Machine Learning are revolutionising clinical trial data management by enhancing efficiency, streamlining processes, and minimising human error. This course will be of use in both the pharmaceutical and medical device industry.

30 June 2025
+ 6 November 2025 »

from £649

Need help?  Enrol/reserve

Course overview

Artificial Intelligence (AI) and Machine Learning (ML) are rapidly reshaping the clinical trials landscape, driving innovation in how research is designed, conducted and evaluated. While these technologies hold immense promise to enhance efficiency, reduce costs, and improve outcomes, their adoption is paired with ethical concerns, prompting the development of robust regulatory frameworks to guide their responsible use. For professionals in the field, understanding the fundamentals of AI and ML and their implications is becoming increasingly essential.

This comprehensive one-day training course provides an overview of AI and ML, focusing on their applications in clinical trials and the regulatory and ethical considerations that accompany their use. Participants will explore how AI and ML are being used to optimize trial efficiency, predict patient outcomes, and support adaptive trial designs. The course will also examine the regulatory frameworks, including the EU AI Act and related regulatory initiatives, to ensure compliance and ethical use of these technologies in a highly regulated environment.

Through engaging lectures, real-world case studies, and interactive assessments, attendees will gain valuable insights into the transformative potential of AI and ML in clinical trials while understanding the challenges and responsibilities associated with their implementation. Join us to enhance your knowledge of these cutting-edge technologies and their role in advancing clinical research.

This course is part of our range of Medical Devices training courses - now also including Medical Devices Cyber Security training to help improve your data security.

Benefits of attending

  • Explore the fundamental concepts of AI and ML
  • Learn how to address common challenges with cutting-edge solutions
  • Explore real-world use cases of AI-powered tools for clinical trial optimization
  • Understand the ethical and regulatory requirements essential to adopting AI in clinical settings
  • Reflect on change management in people, process, and tools for implementing an AI based tools
  • Prepare for the future of clinical trials and stay ahead of industry advancements

Who should attend?

This course is aimed at anyone working in clinical research, clinical operations, data management, regulatory and compliance, and associated functions seeking to leverage AI and ML in clinical trials. Whether you're new to AI/ML or looking to deepen your understanding, this course provides valuable insights into how these technologies are reshaping the clinical research landscape.

Enrol/reserve

This course will cover:

Introduction to AI and ML

  • Key concepts and terminologies
  • Types of machine learning
  • Applications in healthcare, trends and innovations

Applications of AI and ML in clinical trials

  • Opportunities and challenges
  • Real-world data analysis
  • Trial design and simulation
  • Patient recruitment and retention optimization
  • Predictive modelling for outcomes

Applications of AI and ML in clinical trials cont'd

Patient monitoring and safety surveillance
Clinical data management and analysis
Workflow optimization

Regulatory landscape for AI in clinical trials

  • Overview of FDA, EMA, and other relevant agencies’ positions on AI and ML
  • Validation and approval processes for AI-based tools
  • Requirements for data handling and reporting

Ethical aspects

  • Transparency, fairness, and accountability
  • Mitigating bias in AI models
  • Balancing innovation with patient safety

Integration and future directions

  • Steps to incorporate AI into clinical trial workflows
  • Overcoming common obstacles in AI/ML adoption
  • Future directions

Enrol/reserve

Zuzanna Kwade
Dedalus Healthcare

Zuzanna Kwade is Software Clinical Evaluation Lead at Dedalus Healthcare. Zuzanna holds a PhD in Biochemistry and has 15 years of experience in clinical and medical research. She is the co-author of several white papers on regulatory aspects of clinical research and clinical evaluation.

Since 2016, she has been actively involved in Clinical Evaluations according to MEDDEV 2.7.1 (Rev.4) for multiple devices, including high risk hardware devices and medical software. She also represented COCIR in the European Union Task Force on clinical evaluation of software and co-authored MDCG2020-1 guidance on clinical evaluation of MDSW.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

30 June 2025

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 15483

  • GBP 649 749
  • EUR 909 1,049
  • USD 1,043 1,199

Until 26 May

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Not ready to book yet?

for 7 days, no obligation

6 November 2025

Live online

09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 15484

  • GBP 649 749
  • EUR 909 1,049
  • USD 1,043 1,199

Until 02 Oct

View basket 

 
Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.

Run AI & ML in Clinical Trials: Fundamentals, Applications, and Regulatory Aspects Live online for your team

1 day

Typical duration

Pricing from:

  • GBP 500
  • Per attendee, based on 10 attendees
  • Course tailored to your requirements
  • At your choice of location, or online

 

We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy