Patient recruitment for one of the world’s largest CROs

July 8, 2024 |

Our client is one of the world’s largest Contract Research Organizations (CRO), with whom Conversis has been working for many years.

At the time of this study, they were handling a number of significant clinical trials for a Top 20 global pharmaceutical company.

At the end of 2022, our client approached us with a new project for said company. They were working on a set of clinical trials to test a drug for the treatment of obesity and diabetes. The aim was to run 3 separate trials of the drug in parallel, testing efficacy and safety. In the highly competitive market of obesity treatments, the client needed our help to ensure their patient recruitment materials were meaningful and effective across a very large international target audience, and that these materials met regulatory submission requirements and deadlines in order to be approved.

THE CHALLENGE – SO MUCH CONTENT; SO LITTLE TIME!

This project was going to be one of the biggest of the year for our client (and – by extension – for us)! We were looking at about 140 language combinations across 3 simultaneous projects, with individual pieces of material up to 8,000 words in volume! Submission deadlines were incredibly tight given the scope, and all materials were to be patient-facing and print-ready, so nailing the multilingual artwork would be key. As for all materials of this type, we would need to complete translation, 2 steps of review, QA, DTP, and certification. And given the wide-ranging international remit, we would have to create a number of country-specific sources and submit different formats for those with unique regulations around patient recruitment. Add to this the fact that countries’ approval processes all moved at different paces, and that the client would add new files to the scope as the project progressed, and you’re left with one of the more challenging patient recruitment projects we’ve seen – and, believe us, we’ve seen some things!

To summarize, the challenges of this particular project were:

WHAT WE DID

Given the extremely tight deadlines we knew would be coming down the line in the latter stages of submission, we started translating draft versions of the relevant content early on. This meant that final versions, when they came, would involve updates and amendments, rather than wholesale translation, saving precious time when it really counted. This process was facilitated by our translation memory, which allowed us to isolate only content that had been changed since last translation. Country-specific sources had to be recreated at each “retranslation”, so we implemented strict version control across all countries of reference. We also made use of the many helpful productivity tools our Tech team have created for just this kind of work over the years – enabling shortcuts to footer conventions, filenaming, and other organizational aspects of the job.

At the final stage, all translated and approved content needed to be incorporated into design layouts appropriate to the target audience and country. With significant delays in some countries’ approval process, in certain cases we had just 3-4 days to process all files through retranslation and finalize layouts! This was further complicated by Sponsor updates to the artwork at the last minute, something that can happen when content is finally seen in context at crunch time. So it was many hands on deck in the DTP and QA teams too, as everyone worked collaboratively to get this work over the line.

THE RESULT

And over the line it went, with all materials across all countries and languages fully finalized and submitted in time for approval. Two months later, the first patients were already enrolled in the study, and a month after that, the medication was already being tested. This was a big win for the CRO, and an important milestone for the pharmaceutical company in their long-term strategy.

The feedback from our client was glowing, and working through this tricky project together has further cemented what was already an excellent collaborative relationship.

THANK YOU SO MUCH to all the Conversis team for working tirelessly on this complex, challenging and demanding programme […] I am really pleased that the Conversis team had our back on this and achieved the impossible!

Senior Patient Recruitment Lead

If you’re looking for advice on localizing your patient recruitment and retention materials or would like to discuss how best to tackle a tricky multilingual submission, get in touch. The Conversis team will be happy to offer support and guidance, and help you get your project well on its way.