A Personal Service from Experienced Professionals

User Testing

User Testing/Readability Testing

Cambridge Regulatory Services is one of the leading providers of readability testing in Europe

Work with us for:

Fast turnaround

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

A name well known and trusted by Health Authorities

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 

Competitive Pricing

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.

What is User Testing (for medicinal products)

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

Is it mandatory?

User Testing of Patient Information Leaflets has been mandatory in the EU since 2005.

Benefits of CambReg’s User Testing Services

Our experience

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:

  • Novel preparations submitted via the Centralised Procedure
  • Generic products submitted via the Mutual Recognition and Decentralised Procedures
  • Herbal preparations
  • ‘Switch’ applications (legal status change)

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

What we offer

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.

Our ‘no frills’ Service – ideal for clients with generic products - includes

  • Initial client consultation
  • Independent review of the leaflet
  • Minor rewrite of leaflet (up to 4 hours)
  • Preparation of protocol
  • Preparation of questionnaire
  • Pilot Test/Round 1/Round 2 Final Report (eeach copy)
  • Client liaison /HA liaison (up to 2 hours each)

Additional Services

Large portfolios of products

  • Strategic advice
  • Grouping/Justification for not testing
  • Focused testing

Harmonisation before testing

  • Across a product range
  • Across a set of countries
  • SPC/Leaflet comparison

Leaflet Text Amendment

  • Writing/rewriting of leaflet
  • Reformatting to Quality Review of Documents (QRD) template

Leaflet mock-up Design

  • Production
  • Amendment

Recruitment of specialist panel (for unusual  or orphan diseases

  • Audio recording of interviews

Rapid Response to HA requests

  • Reformatting to Quality Review of Documents

 

Does User Testing make any difference to the readability of leaflets?

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.

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Testimonials:

Bausch & Lomb Germany

“Thank you very much; it was a pleasure working with you. Everything went so smoothly and quick.  So we will gladly recommend you.”

Johanna Maass

Regulatory Affairs Manager

Generics UK Limited (now Mylan)

“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.”

Kevin Airey

Senior Registration Manager

Grifols UK

 “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”

Clive North

Technical Director

 LPC Pharma Group

“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

References

1. Council Directive 2001 83 EC: Guidance concerning consultations with target patient groups for the package leaflet

2. Questions and Answers to support the MHRA Guidance on User Testing (June 05)

3. EU Guidance concerning consultations with target patient groups for the package leaflet (May 06)

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)

6. Further guidance on designing Patient Information Leaflets and how to achieve success in User Testing (Mar 07)