AI-supported creation of clinical trial synopses - Johner Institute

Seminar on AI-supported synopsis creation as a profound basis for clinical trial documentation

Create legally compliant study synopses faster and more efficiently –
with AI support and regulatory expertise.

The challenge

As a Clinical Affairs Manager, you face enormous challenges: Notified bodies and authorities object to your clinical data. The time pressure is immense, and determining the study design, endpoints and case number planning consume valuable resources. At the same time, there is often a lack of expertise in using modern AI tools efficiently and in compliance with regulations.

The good news: In this seminar, you will overcome your uncertainty and develop enjoyment and confidence in working with AI. Not only will you become more productive, but you will also become a valued driver of innovation in your company.

The consequences of inaction: Without professional support, you risk delayed market approvals, costly rework and, in the worst case, the failure of the entire clinical trial – with all the negative consequences for your company and your personal reputation.

Specific content for successful studies

Highly specific content for medical devices and clinical affairs allows you to learn in your specialist terminology. You can apply what you have learned immediately, avoid costly mistakes and manage your CROs optimally – without the risk of having to repeat the study.

Tried and tested AI prompts for greater time savings

We provide you with tried-and-tested prompts and demonstrate their use live. You don't have to start from scratch, but can adapt proven templates directly to your specific requirements. This saves time and minimises frustrating experiments.

Remote format for integration into everyday working life

The seminar takes place remotely over two half-days. This allows you to integrate this valuable training perfectly into your everyday working life, try out what you have learnt straight away and still manage your day-to-day business.

Comprehensive approach to regulatory certainty

Learn how to use AI in accordance with MDR, ISO 14155 and ISO 13485. We not only teach you about the technology, but also best practices for minimising hallucinations and creating evidence-based study designs of the highest quality.

Target group

This seminar is specifically aimed at specialists and managers at medical device manufacturers:

  • Clinical Affairs Manager
  • Clinical Trial Manager and Clinical Project Manager
  • Medical Writer
  • Regulatory Affairs Manager with reference to clinical trials
  • Employees who prepare study synopses and obtain CRO quotes

Ideal for anyone who has a basic understanding of clinical trials but wants to increase their efficiency with modern AI tools.

The seminar in detail

In this practice-oriented seminar from the Johner Institute, you will learn how to use AI professionally to create study synopses. The two-day remote training course combines in-depth specialist knowledge with practical exercises and immediately applicable solutions.

What you can expect:

  • Fear-free and structured introduction to AI technologies – also suitable for beginners
  • Specific instructions for creating study synopses that comply with the law
  • Live demonstrations and practical exercises
  • Extensive preparation and follow-up materials
  • Direct access to proven prompts and best practices

Your benefits: After the seminar, you will be able to create study synopses more quickly and efficiently, minimise the risk of regulatory complaints and position yourself as an innovative expert in your company. You will become a valued contact for modern, efficient working methods in clinical affairs.

Contact us without obligation

For further information or to register for the seminar, please contact our clinical experts without obligation.

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