Cambridge Regulatory Services is one of the leading providers of readability testing in Europe
Our average turnaround time for a standard PIL User Test is about 5 weeks. We can perform tests in under 2 weeks if the conditions are right
CambReg reports are routinely submitted to numerous EU Health Authorities; in the UK alone we are responsible for approximately 20% of all User Testing reports submitted to the MHRA.
On many occasions the leaflets we have tested have featured as the MHRA's "PIL of the Month".
MHRA inspectors were' satisfied' during an unannounced visit to review our processes
Our loyalty and / or multiple test discount packages, means that CambReg has a large portfolio of satisfied clients who return for this service time and time again. We offer value for money and a high quality of service.
Directive 2001/83/EC (as amended by Directive 2004/27/EC) requires that consultation with target patient groups (‘user consultation’) be carried out to demonstrate the readability and usefulness of the package leaflet to patients.
Article 59(3): “The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use.”
Readability Testing (or User Testing) of the leaflet is a commonly accepted way to satisfy these requirements
User Testing of Patient Information Leaflets has been mandatory in the EU since 2005.
Cambridge Regulatory Services has been providing the pharma industry with a superlative User Testing Service since 2004, leading the way, long before testing was mandatory. Now a highly successful core part of our business, CambReg’s experienced User Testing team has completed testing over 800 leaflets (307 full User Tests and over 500 bridging reports /focus tests), working across all sectors of the pharma industry including:
Experience has shown that many companies do not capitalise on the option to bridge / focus test and often perform full testing unnecessarily. CambReg’s dynamic approach to bridging and focus strategies for whole product portfolios has proven to be highly successful and has significantly reduced the overall costs of this process for our clients.
Our approval rates are 100% - leaving aside projects where clients have ignored our initial advice regarding leaflet changes
CambReg employs a User Testing method developed in Australia in the 1990s, which is outlined in current EU and MHRA guidelines (2, 3). The process involves showing the leaflet to ‘the people who are likely to rely on the package leaflet' (4) i.e. volunteers from the potential patient population who then identify the areas where improvements are necessary to ensure that the leaflet is legible, clear and easy to use.
The volunteers, selected from an extensive data base of thousands are invited in for testing no more frequently than 6 months. Our friendly team together with our dedicated User Testing suite provides them with an experience that they are happy to repeat.
Large portfolios of products
Harmonisation before testing
Leaflet Text Amendment
Leaflet mock-up Design
Recruitment of specialist panel (for unusual or orphan diseases
Rapid Response to HA requests
Historically, many leaflets were in general poorly laid out and too lengthy due to the complexity of the Summary of Product Characteristics (SmPC) and / or information being given in scientific language in order to fulfil regulatory requirements. Patients quickly lost interest in the document, failing to read or understand information crucial to the safe use of the medicine. Our accumulated experience of writing and testing leaflets for different therapeutic areas has shown that at the end of the testing process every leaflet is significantly improved. Patients benefit in real terms being able to more easily find and understand key information relevant to the safe and effective use of a product.
“Thank you very much; it was a pleasure working with you. Everything went so smoothly and quick. So we will gladly recommend you.”
Regulatory Affairs Manager
“Generics (UK) has used Cambridge Regulatory Services for 18 months as the Company’s regulatory advisors, assisting us with PIL User Testing. During this period of time, they have shown a good understanding of both our needs and that of the Health Authorities involved. Their advice and experience has proved to be invaluable. We have always found them most approachable and are happy with the work they have undertaken for us.”
Senior Registration Manager
“Their User Testing PM and support team are the ‘best’, they manage to be helpful and extremely quick and always there when you need them”
“I am impressed with CambReg’s project management approach to handling the requirements necessary to collate data for our regulatory submissions”
Anthony Asindi BSC (Hons) Pharm MPQG AMBiol
Head of Regulatory Affairs & Quality Assurance
1. Council Directive 2001 83 EC: Guidance concerning consultations with target patient groups for the package leaflet
4. Guideline on the readability of the label and package leaflet of medicinal products for human use (Revision 1, Jan 2009)
5. Guidance for the Pharmaceutical Industry on the use of Bridging Studies to demonstrate compliance with article 59(3) of Council Directive 2001/83/EC) [Consultation with Target Patient Groups] (Dec 06)