Find
Can the patient find the relevant information?
PHARMBICON
We make readability simple.
Patient Information Leaflet readability testing
Readability testing, bridging, a PIL audit or PIL development? We identify the right pathway, then manage the project through to documentation ready for use in the regulatory process.
Trusted by Polish and international pharmaceutical companies, including global pharma companies.
About us
Readability is our specialism
Since 2007, PHARMBICON has focused exclusively on Patient
Information Leaflet readability.
This specialism gives us in-depth readability expertise while
allowing us to see it in the broader Regulatory Affairs context. We
understand the regulatory process, product information requirements
and the decisions Regulatory Affairs teams need to make at each
stage of a project.
That is why we do more than simply deliver the service requested. We
help identify the right pathway – from readability testing and
bridging to PIL audits and end-to-end PIL development.
Our team of Regulatory Affairs experts combines regulatory knowledge
with hands-on experience in readability testing and patient
information development.
Established in 2005.
Readability testing since 2007.
2000+ completed projects.
0 rejected readability projects.
Methodology
PHARMBICON
3z Method
The method defines three conditions for effective patient
information: patients need to FIND the information, UNDERSTAND it
and know how to ACT on it.
We conduct readability studies using a qualitative
methodology based on the Australian model of user testing for
patient information.
3z stands for the three steps in Polish: ZNALAZŁ → ZROZUMIAŁ → ZASTOSUJE.
Understand
Do they correctly understand what it means?
Act
Do they know how to act on the information?
Finding information is only the beginning.
Information fulfils its purpose only when the patient knows how to act
on it.
Services
One specialism. Complete support around the PIL
We tailor the scope of work to what the project actually needs –
from readability testing and bridging to PIL audits, end-to-end PIL
development and translations.
We recommend a new readability test only when it is genuinely
justified.
PIL Readability Testing
We manage the entire readability testing process – from expert review of the PIL and testing with participants to the final report ready for use in the regulatory submission.
Learn more →Readability Bridging & Portfolio Analysis
We assess whether existing readability studies can be used to support additional PILs – including across an entire product portfolio.
As part of the bridging assessment, we compare the bridging PIL with the reference PIL and prepare a bridging report ready for use in the regulatory submission.
The goal: a new readability test only when it is genuinely needed.
Learn more →PIL Audit & Optimisation
A PIL audit helps identify issues before readability testing begins or before the next stage of the regulatory process.
We assess the PIL against the SmPC and the current QRD template, as well as for readability and comprehensibility. We do not simply identify problems – we recommend specific solutions.
Learn more →From SmPC to Final PIL
Using the current SmPC and QRD template, we develop the content
and structure of the PIL
from the ground up.
We also develop the leaflet’s graphic design,
taking into account the requirements for clear and readable
patient information.
Product Information Translation
We provide specialist translations of PILs, SmPCs and readability testing documentation, preserving medical and regulatory meaning as well as consistency of patient information.
Learn more →Knowledge hub
Readability without the headache
Bite-sized insights for Regulatory Affairs. No unnecessary theory.
Practical insights into readability testing, PILs, bridging and the challenges Regulatory Affairs faces in day-to-day work.
Regulatory Affairs checklist
Before you start a readability project
10 questions. A few minutes. Fewer surprises later.
Latest articles
QRD-compliant. But is it readable?
Compliance with the QRD template does not necessarily mean that patients will be able to find and understand the information they need. We explain where regulatory compliance ends and real-world readability begins.
Read more →Positive test outcome? That’s not the whole story
Readability testing is not an exam that a leaflet needs to “pass”. We explain why a positive outcome matters, but what matters most is whether the information actually works for the patient.
Read more →PIL graphic design: just decoration? Anything but
Patients do not use a Word document. They use the finished leaflet. We explain why PIL graphic design is part of readability, not simply the final stage of document layout.
Read more →Contact PHARMBICON
Let's discuss
your project
Please briefly describe your project or the support you need. We will contact you to discuss a possible solution and the next steps.
PIL@pharmbicon.com
+48 502 67 19 64
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