Case Study

MDR/IVDR: Multilingual labeling compliance at scale

Learn how we revised inefficient content processes for a global pharmaceutical company 




The Client

Our client is a Fortune 100 life sciences company, whose medical device divisions have been manufacturing devices for over 50 years. Acolad has been translating technical documentation consisting of Instructions for Use, user’s manuals, software, and packaging for over 12 years.

The Challenge

As a manufacturer of pharmaceutical products, including drugs that many of us are familiar with, our client shoulders a great deal of responsibility in keeping consumers safe.

As part of post-marketing safety surveillance programs for drug and therapeutic biologic products, they must record adverse events into a proprietary system in order to ascertain patient safety, risk management and product improvement. These events are observed by clinicians in Canada and reported in French.

However, the reports require translation into English within two hours to remain compliant with the health authorities. This proved to be a demanding task for the client’s small internal team, who needed the freedom to maintain focus on drug safety.

They therefore decided to outsource the translation step of the overall reporting process. 

The Solution

The Acolad response took advantage of economies of scale as well as technology to deliver a cost and time-efficient solution. This consists of:

  • A combined translation memory (TM) plus machine translation (MT) strategy to reduce the volume of new translations

The content is processed with the legacy TM first, for reuse of legacy-approved translations. MT is then applied to the remaining new content to further reduce volume. Finally, qualified medical device linguists post-edit all output to ensure consistent quality.

  • Automation deployed with the customer portal as the entry point

Requests flow directly through to our production automated workflow. This would allow the client to feed requests to us through the customer portal which automatically flowed to our TM+MT processing. In addition, our workflow allows for setup of the program teams so that once ready for linguists, files could automatically flow to those individuals assigned to the program. Many of the tasks handled by the project manager were fully automated.

  • Acolad ownership of the review/validation process

Rather than using client reviewers which can delay delivery and result in missed deadlines, we moved to our own validation step using our linguistic resources for this review. This also allowed us to take advantage of our automated workflows.

  • Economies of scale advantages

Our client provided a detailed forecast of the workload, which enabled us to provide customized pricing. 

Because Acolad works as an extension of the client’s team, we are able to craft solutions to better meet their needs, saving them time and resources. This integration helps us understand their processes and challenges, allowing us to deliver large numbers of files in record time. We look forward to an ongoing partnership where we can continue to support the client’s translation needs.

Nynne DeNiro, Director of Account Management, Acolad


The Result

While still ongoing, the client has already seen the following results:

  • 1-2 week savings in turnaround time for each piece of content    
  • 30% savings through TM and MT deployment, streamlined processes, workflow automation and volume pricing
  • A scalable solution that can be applied to any major regulatory changes that may require a mass update of content. 

We are already discussing next steps for even more efficiency, namely through the implementation of structured content authoring and content management technologies – always fully integrated in our translation systems for an end-to-end solution and greater efficiencies long term.