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.
You’ve completed your clinical trial. Now what?
Well, according to a new EU ruling - EU Clinical Trials Regulation No. 536/2014 - all clinical trial sponsors must provide a lay summary of their results within one year of completing the trial.
Patient-centricity isn’t just about meeting regulatory requirements though, but going a step further and creating something truly ‘lay friendly’.
We can get you there, no matter what stage of the process you are at.
What is a clinical trial lay summary?
A brief outline of the design and results of clinical studies written using plain English is called a lay summary. These summaries (also called layperson summary, plain language summary, lay language summary, simple language summary, and trial results summary) are intended to make the clinical results of these studies understandable and accessible to patients and caregivers.
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
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.
Our services include:
Writing a lay summary from a clinical study report synopsis
Enhancing an existing lay summary
Creating a lay summary template
Graphic design and layout
Translation into other languages
Lay person input and review
User Testing to inform summary design and content
Training your team in writing for lay readers
Check out our guide to clinical trial lay summaries