Project – Readability Testing, comprising of
Summary of project
There was a requirement in Italy to update leaflets to be considered readable for the national market. We were successful in winning a tender to perform such work for a number of companies.
Following a request from the Italian health agency AIFA, all MAH had to adapt their leaflets to the current QRD which also involved a simplification work, as before that the Italian leaflets were a mere copy of the SmPC. The updated leaflets had to be readability tested.
The deadline was tight for the amount of work to be done. There were uncertainties about whether a simple formatting of the PILs into the new QRD would be enough, or if AIFA would accept Bridging to the English tested products. There was a general level of uncertainty or experience which meant that we had to lead our clients to ensure success.
Solutions we gave
We contacted AIFA and tried to gather as much information as possible. Before having any signed contract, we recruited a project coordinator in Italy who was a psychologist specialising in patient recruitment. With her help we organised and trained a team of interviewers. Together we hired an Italian native based in our Prague office to coordinate with our clients in their language and we worked with a number different Italian medical writers who all had different methods of writing. We had to guide them on a standard procedure and style so there was consistency across the board. At the time we were also supplied with text from medical writers that had to be reviewed many times, but our team had the experience to arrange for the documents to be fully compliant and finally deliver the projects within the deadline.
Health agencies often request that adaptations have to be made to leaflets, meaning our project managers have to be flexible when promising deadlines and delivering the full scope of a project. We managed this successfully.
This project was a challenge due to a number of external factors, most notably the lack of experience in Italy with this process and between companies in the tender who all had their own timelines and ways of working. Without string project management and an understanding of how to coordinate and streamline activities, it could have easily become a very difficult project. Our lengthy knowledge and past experiences in Readability Testing was invaluable in minimising the potential issues and ensuring successful leaflets were generated and tested in the end.