Why struggle through readability testing?
We’ve been taking the time and guesswork out of readability testing for 20 years.
Take the hassle out of readability testing
If you're in pharma or medical devices, you know how critical a readability test is for regulatory compliance. But testing can be a headache. From recruiting the right participants to editing leaflets patients actually understand, it’s a lot to manage. With MediLingua, you can leave the complexity to us.
We do it all
We run readability tests for drug labels, package leaflets and SSCPs. We pull in participants, draw up safety questions, conduct interviews, edit where necessary, and send you a fully traceable test report.
So you don’t have to
Whether you're submitting to regulatory authorities or updating your SSCP, we make sure your materials meet all readability requirements. You save time, reduce stress and get it right first time.
Why trust MediLingua with your readability testing?
We’ve been testing since 2005
We’ve helped pharma and medtech with their readability testing since it became an EU requirement. That’s almost 20 years of testing package leaflets, IFUs and SSCPs.
We’ve tested 100s of texts
With this many tests under our belts, we can sense a problem a mile away. So you only perform the readability test once, which cuts costs and time invested.
We are medical-text people
But we are not medical people. In other words, we can understand any medical document you throw at us. But we still see it from the patient’s perspective. This helps us make the text simple and clear for the lay reader.
We are expert editors
In nearly 3 decades, we’ve seen and fixed every kind of issue in medical texts that you can imagine. If there are issues, we can show you how to fix these errors. Or we can fix them for you.
Translation certificates
MediLingua is certified to ISO 9001 and ISO 17100. These certifications are the two stamps of approval that regulatory authorities look for, making our translations perfect for your regulatory submissions.
Need a readability report for your regulatory submission?
FAQs
The readability test is a small but crucial step in your MAA. You’re right to think carefully before choosing the right provider. Read on for further reassurance. If you’ve got questions, we’d love to hear them.
What’s your process for readability testing?
First, we take your label, package leaflet or SSCP and screen it for problems. We check you’ve followed the QRD template, MedDRA terminology and EDQM terminology. We also look for obvious problems that would cause the text to fail the test. If we find any, we come back to you with suggestions on how to fix them. These pre-test checks save you time and money. Because the last thing you want is to fail the test and have to do it again.
Once your text is test-ready, we draw up a list of questions about the key safety aspects of your product. These are the parts of your patient text that lay readers must understand.
We enrol 20 to 25 lay participants if we’re performing a readability test of a package leaflet for a medicine. For other texts, we enrol around 10 to 15 participants. These participants must:
1. not have medical knowledge
2. include people over the age of 60
3. include men and women
4. have an average level of education
Next, we conduct and record one-to-one interviews with each lay participant. We interview them in a quiet, distraction-free environment. We ask each one the same questions. We closely observe how much time and effort it takes the lay participant to answer the questions. If they answer incorrectly, we ask them what the problem was. If they answer correctly, we ask them what could be made clearer.
Please note: If there is a clear problem with your text after the first 3 interviews, we stop. We suggest ways of making the text easier to read and validate them with you. Then we retest the new version of your text.
We follow EU guidelines on readability tests for labelling and package leaflets.
Once the test is complete, we provide a test report detailing the participants, test phases, and changes made to your text based on the test outcome.
Still unsure about some aspect of readability or usability testing? Get in touch and we’ll answer any questions you have.
Do you offer usability testing as well?
We do usability testing, too. We check that IFUs are easy to follow and allow your end users to safely operate your product. Typically, we perform usability testing for high-end hospital equipment, test kits and home-use medical devices. You can book your usability test here.
There is a difference between a readability test and a usability test. A readability test is performed on a document for patients. It assesses how easily a patient can find and understand critical safety information in the document we’re testing. An example of critical safety information is “Can I take this medicine if I’m pregnant?”
A usability test is performed on the user manual or IFU of medical equipment or a medical device. It assesses how easily a user can operate the device or equipment using the instructions in the manual or IFU.
Are there other ways to do readability testing?
Yes, there are free tests like the Flesch Kincaid and Fry readability tests. These do basic calculations. For example, they count the number of words in each sentence. Then, they apply a formula to the result to give you a readability score. These free tests eliminate simple problems of long sentences and difficult words.
But free tests like these are not accepted by the regulatory authorities. Besides, can a statistical model recreate the real-life experience of a 62-year-old who’s not sure whether the medicine they’ve just been prescribed is safe to use with the anticoagulants they forgot to tell their doctor about? We don’t think so.
What is "bridging analysis"?
If possible, we can also do what is known as a “bridging analysis”. Here, we test your patient text or user manual against a previously validated text. This can save you certain costs compared to a full readability test. Contact us for more information.