Adverse Clinical Trial Events: Are you prepared?

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When life science companies launch clinical trials in markets around the world, translation is a key requirement.  Unfortunately, it’s one of the last issues to consider when planning a global clinical trial. Translation is inarguably on the critical path to helping achieve clean data and, ultimately, the trial’s success.

Adverse events can derail a clinical trial—or sales of approved products—when not properly managed. In-market regulatory bodies require timely reporting of all adverse events (AEs) and severe adverse events (SAEs). With that, life science companies need an established translation strategy to communicate such negative episodes in a timely manner – as well as in the proper languages.

The dynamic duo of AE goals: speed and accuracy

Life science companies typically choose one of two methods for adverse event translation: internally through the organization’s safety department, or outsourcing. Companies that translate the reports themselves often experience long delays because they don’t have translators dedicated to the effort; and the employees who do the translating have other job responsibilities. A long translation process postpones the reporting and the release of the adverse event to the regulatory body (typically required within 24 hours for SAEs and 48 hours for AEs).

Companies choosing to outsource to a third-party are usually hoping to avoid burdening their team with translation work, but still need to translate and report the event as quickly and accurately as possible. Unfortunately, not all third party providers are equipped to support the time-sensitive, quality-driven requirements of adverse event translation.

How an expert partner can help

Lionbridge Life Sciences has an established track record of reducing translation turnaround times for clients, often by more than 30%. With a dedicated Adverse Events team and fully-operationalized program in place, Lionbridge can deliver priority services ideally-matched to the unique requirements of time-sensitive, multilingual AE and SAE reporting.

Adverse events program offerings:

  • An exclusive, highly-vetted pool of translators with impressive clinical backgrounds and deep, hands-on experience in content-critical AE and SAE translation across 250+ languages
  • A vast global footprint that can leverage different time zones so that AE and SAE translation work is ongoing and efficient
  • Fully documented, quality standards and web-based technologies to support efficiency and process optimization from AE receipt to completion
  • An on-demand quotation tool for instant project estimating and accurate forecasting
  • An online translation platform linked to the latest global health authority terminology databases ensuring strict adherence to local linguistic standards
  • A centralized program management approach featuring Freeway, our web-based service delivery platform that facilitates streamlined communication, report generation, and collaboration between your organization and our global network for consistent, high-quality deliverables in all languages
  • A highly scalable operation to accommodate the fluctuating numbers of AEs and languages during the trial’s duration

Lionbridge  specializes in all aspects of clinical trial translation, from pre-clinical and clinical to post-approval pharmacovigilance, providing Certificates of Accuracy for the utmost assurance. Wherever you are in the process, Lionbridge has a solution to help your trial succeed globally.

Reporting adverse events quickly and expertly is undoubtedly challenging, given the differing international regulatory standards. A proven partner and process in place can significantly assist your global clinical activity and sales expansion.

To learn more about how Lionbridge can readily deploy an adverse and severe adverse event translation program to meet your needs, contact Lionbridge Life Sciences.

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