Our relationships with customers are designed to support positive outcomes, with orchestrated management of project requirements and team expectations along the way. Lionbridge Life Sciences deploys the optimal process to achieve maximum efficiency, cost savings and accuracy.
Gain further insight on how Lionbridge Life Sciences collaborates with customers to support their language goals:
Automated Translation Workflow for High-Volume Support Content Translations
A global medical device manufacturer with a strong track record of maintaining full FDA compliance was faced with a new reporting requirement involving review of all critical global customer support situations where patients may have been at risk.
- Customer support cases were documented and maintained in various systems and in over 20 languages; FDA requires single format and English copy
- The effort entailed the translation of hundreds of thousands of words per week from hospital communications all over the world and across all channels including e-mail threads, call logs, engineering reports and more
- Any (potential) patient safety issues must be reported to the FDA within days or even hours after they have been identified and reported
- Lionbridge implemented a custom translation model and workflow that combined fit-for-purpose quality including advanced use of translation memory technology and machine translation with light post-editing
- A real-time connector was built between the customer support platforms and the Lionbridge Freeway portal to enable a continuous stream of content pushed out to translation
- Current volumes are approx. 500,000 words per week from 21 languages into English, with peaks in the early phase of over 1 million words a week
- Translated support cases for urgent categories are delivered back to the customer within 24 hours, seven days a week. Regular content is translated and delivered within three days
- An SLA that defines very strict KPIs around turnaround time, quality, and CAPAs
- A fully automated process that has ensured a 99.5% score on agreed turnaround times over the past 4 years
- Full FDA reporting compliance
Strong Collaboration a Framework for Quality Translations
The German office of a leading global medical device organization was looking to outsource the entire documentation and translation workflow for its wide range of production documentation according to strict company requirements.
With a continuously growing translation volume in the absence of a dedicated internal project management or translation team to coordinate workflow, the effort had become a daunting task for the Regulatory Affairs team.
The Company was seeking a provider partner who could navigate the decentralized infrastructure of the various business groups and national entities– each with their own legal, regulatory and operating requirements– and deliver a well-conceived process that would support intensive translation activity in this highly specialized medical area.
- Intensive internal requirements spanning quality assurance, product planning, and operating SOPs
- Comprehensive protocols for external requirements addressing regulatory compliance and process audits
- Limited capacity for input and feedback on how best to optimize the process due to RA team’s pressing job demands
- A multitude of company contacts, channeling information regularly, containing complex, scientific graphics and terminology
- Growing list of languages; a variety of documentation content and formats
- A comprehensive planning session to fully audit existing translation process, and internal and external requirements
- Assignment of a dedicated Project Team at the Lionbridge Life Science Amsterdam Center of Excellence possessing deep knowledge of subject matter and regulatory requirements of applicable projects. Work was supported by an extensive, integrated Quality Assurance Program designed to document and comply with all quality specifications
- Consulted on the reduction of booklet source text to accommodate the growing list of languages under the strain of a greatly accelerated timeline. Project Team worked swiftly yet competently to redesign booklet into a “skinny manual” to meet existing box size and regulatory packaging restrictions, all within legal compliance parameters
- Centralizing specific know-how into one Lionbridge Life Sciences Center of Excellence facility and adopting a workflow to transfer all requests through a qualifying channel streamlined all communications. The outcome: an efficient process, quality translations, and real-time monitoring capability
- Market approvals from in-country regulating authorities were successfully obtained
- Investment in building a true relationship through open lines of communication, personal attention, and proactive recommendations allowed the Lionbridge Project Management team to further expand its successful partnership across Swiss and French Company boarders. Access to other areas including demanding marketing divisions were readily achieved due to internal word-of-mouth testimonials
- Our “think global act local” approach resulted in continued expansion of our translation services, all while seamlessly ramping up and down resources as needs arose, leading to targeted translation investments for optimized budgeting
Getting Patient Enrollment Goals Back on Track
One of the leading full-service providers for patient recruitment and patient retention was seeking a Localization service partner to provide high-quality translations within aggressive timelines to support patient recruitment campaigns for their global studies.
- The provider was tasked with bringing patient enrollment for four clinical studies—all of which had fallen behind on recruitment goals—back on track
- Studies were run globally in more than 10 countries requiring 15+ different language variants
- Recruitment packages with up to 19 different recruitment documents required translations and approval from Ethics Committee under very tight timeline.
- Close collaboration with the patient recruitment provider through regular planning and status meetings
- Swift adjustments to shifting schedules and language priorities to support customer requirements
- Ad-hoc solutions for challenges that arose throughout the project; in particular, managing the implementation of Ethic Committee revisions which were often less than optimally communicated
- Successful, on-time completion of translations for all locales
- Patient recruitment provider was able to get enrollment goals back on track and delivered the number of patients required for the protocols, reporting an 8 month saving in time
- Lionbridge Life Sciences has been designated as the primary translation provider, with translation services being extended to recruitment campaigns for additional global studies
Going External for Internal Communications Support
This leading pharmaceutical company with commercial operations in more than 150 countries was continuing its steady growth path through organic growth and strategic acquisitions.
Paramount to success was its ability to disseminate a variety of communications to its growing global employee base quickly, carrying forward the established brand tone and localized content to ensure meaning and accuracy.
- A variety of communications materials, with differing levels of educational, technical and standard content
- Existing turnaround time to localize was not in alignment with global business demands
- Growing list of languages
- Internal corporate communications team did not have the capacity nor training to administrate and implement the effort
- A comprehensive planning session to evaluate communications mix, current workflow, operational hurdles, and timing requirements
- Solution integrated three different adaptations of the localization process—standard, rush and critical— each with varying turnarounds times for client to select on a project-by-project basis
- Quality thresholds were developed and aligned to each communication, then matched to the appropriate localization process
- Custom, flexible localization process has resulted in expectations being well-managed and successfully met, making for a positive partnership
- Corporate Communications team now freed up to focus on their respective job responsibilities leading to a more productive, frustration-free group
- Translation and localization services currently being extended to other areas within corporate communications