Summary
Generative AI is moving into clinical development, and the question is how to use it with confidence. This hands-on course gives clinical professionals the skills to apply GenAI to trial planning, protocol review, budgets and risk management in a regulated environment. You practise prompt engineering and agents on realistic trial examples such as inclusion/exclusion criteria, budgets, risk overviews and protocol checks, learn where the risks and limits lie, and leave with a personal prompt library and a plan for your further development.
Key words
Generative AI
Clinical development
Prompt engineering
Agentic work
Life Sciences
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Course leader & lecturers
- Ingelise Bærentzen MelchiorsenCourse leader
IMPLEMENT Consulting Group
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Is this course for you?
Clinical Trial Manager, Clinical Project Manager, Clinical Operations Lead, Clinical Research Associate and Trial Associate, Clinical Development Lead and Medical Director, Medical Writer, Clinical Data Manager and Biostatisticians, and Trial Planning, Feasibility and Budget Specialist.
Also for anyone exploring GenAI's future in clinical development.
What you will learn
- How GenAI and agentic AI work, and which tools to use when ?
- Prompt engineering with persona, audience, task context and tactics, and your own prompt library
- Hands-on use cases: inclusion/exclusion criteria, trial budgets, risk overviews, statistical approach, endpoints and protocol checks against ICH guidelines
- Working with agents: building a simple reusable assistant with human review built in
- Compliant use: FDA/EMA principles, EU AI Act, and which tools may handle which data
- GxP assurance basics: documenting AI use, human review records, and when AI output enters a controlled record
- Verifying outputs: spotting hallucinations and bias, and checking against sources
What your company will get
- Can translate strategy into AI-supported ways of working across their whole team
- Works faster and with better quality across all tasks incl. protocols, trial planning, budgets and trial documentation
- Is trained in the ethical and regulatory use of GenAI, including acceptable platforms and data handling
- Brings back reusable materials, prompt libraries and exercises to share adopting with colleagues
Course calendar
Day 1 (09:00-16:00, face-to-face)
- Introduction and purpose: why AI now, expectations
- GenAI foundations: how it works, risks, bias and GxP basics
- Function-specific application: prompt engineering, agents, real clinical use cases, hands-on tool work
- Reflection and adoption: applying it to your own work
Day 2 (09:00-11:00, online)
- Present back: your use cases and how you have driven adoption of GenAI
Registration
Registration deadline7 May 2027
Lersø Parkallé 101
2100 København Ø
9,200 DKK
Course information
Literature
Prior to the course you get access to mandatory and/or optional readings via your personal Atrium log-in.
Prerequisites
Examination
There is no examination for this course.
Course leader
IMPLEMENT Consulting Group
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11 May 2027
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Want to know more or need help?
Contact Client Manager Christina Spangsberg at +45 39 15 09 22
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