The new EU Clinical Trials Regulation No. 536/2014 requires all clinical trial sponsors to provide lay summaries of the results of their clinical trials within one year of the trial ending.

We know that clinical trials are complex and that meeting regulatory requirements is vital. Turning your clinical study report into something a lay person can understand, in a non-promotional way, is a challenge that requires time and resource.

The European Union’s guidance on writing ‘Summaries of clinical trial results for laypersons’ has now been published.  Theo Raynor examines the guidance document and suggests ways to create clinical trial summaries that the public can understand.

How we can help

Our team has extensive experience of information design, lay writing and knowledge of clinical trials. We have already worked with a number of top pharmaceutical companies to develop lay summary materials – we can help you too!

  • Meet regulatory requirements
  • Reduce demand on internal resource
  • Submit high quality, truly ‘lay’ summaries

What we offer

You may just be setting up your approach to writing lay summaries or already have drafts in the pipeline.  We can help whatever stage you may be at and create a project that is bespoke to you. Your dedicated Project Manager will work with you every step of the way.  Our services include:

Development

  • Writing a lay summary from a clinical study report synopsis
  • Enhancing an existing lay summary
  • Creating a lay summary template
  • Graphic design and layout
  • Proof reading
  • Translation into other languagesClinical Trial Lay Summaries

User engagement

  • Lay person input and review
  • User Testing to inform summary design and content

Bespoke training

  • Training your team in writing for lay readers

We can help you communicate effectively with your patients and the public.

Get in touch