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Global pharmacovigilance for Covid-19 vaccine

Safety program for COVID-19 vaccine: a blueprint for global safety agility 

Linguamatics pioneers in global safety translation program for COVID-19 vaccine global safety monitoring

The problem   Highest and fastest scale ever recorded

Our customer, a leading pharma company commercializing Covid19 vaccine, and its pharmacovigilance provider for safety monitoring were partnering with Linguamatics for the translation of adverse events.

As the pandemic hit record number on the global stage, the entire solution had to scale to absorb high volumes while delivering outstanding quality from all language sources, allowing safety protocols to be fully applied despite the crisis.

Our customer and its pharmacovigilance partner were faced with many challenges:

  • Very complex management due to pandemic conditions: global scale, tight deadlines, very high volumes
  • High overlook from regulators and authorities due to the world attention on vaccines developments
  • One of the highest and fastest scale ever recorded: from <100 cases/day up to 1000+/day in less than 2 months
  • 55 language combinations

The solution   End-to-end global safety monitoring program

Linguamatics levered its integrated language solutions capabilities and layered them on top of the pharmacovigilance safety platform:

  • Linguistic AI Technology: Linguamatics translate has the only Machine Translation engines specifically trained for clinical purpose, allowing to obtain faster results
  • Expert translations professionals looped in on demand for certification
  • Dedicated workflows and ongoing KPI monitoring
  • Linguamatics hub platform allowing accelerated project management with “follow the sun” model (27/7 coverage)

Thanks to its unique understanding of healthcare processes, Linguamatics can offer deep integration with any pharmacovigilance provider and fast track the scalability of capabilities across languages, while saving time and money in the process.

Results   Successful program despite extraordinary conditions

Linguamatics' partnership and integration into the pharmacovigilance platform allowed an end-to-end safety model which delivered the program successfully despite the extraordinary conditions:

  • Fast implementation with integrated “plug and play” model avoiding 3rd parties
  • On time delivery recorded on compliance and far above expectations given the context, outperforming all other language providers