Global CRO accelerates language translations and reduces costs

Case Study 08 | Clinical Translation

Introduction

A Clinical Research Organization (CRO) came to us with a large volume of technical medical data and an ineffective translation system. Here’s how we transformed the CRO’s language process to be faster and more cost-effective - all with zero quality errors.

This global CRO offers a full range of research services to support worldwide clinical trial strategies for the pharmaceutical, biotechnology and medical device industries.

With approximately 5,000 employees across six continents and experience in more than 100 countries, the CRO’s safety specialists are responsible for the collection, translation and reporting of large amounts of technical medical data for pharmacovigilance requirements and study reporting purposes.

On any given day, the CRO’s safety specialists receive information from 350 clinical and post marketing studies taking place worldwide. The volume of incoming data is very high, with as many as 60 safety specialists at a time submitting reporting data that requires translation.

Chapter 1

THE CHALLENGE

The process for translating this data was decentralized and managed by multiple Language Service Providers (LSPs) in different locations.

“The translation of safety source documents was subject to numerous errors and delays, which was unacceptable when the case in question is an expedited safety report with medically significant information,” said the CRO’s Director of Safety and Pharmacovigilance.

Additionally, because the process was fragmented, it was extremely difficult for the safety specialists and the CRO management team to gain an overall view of workload requirements, translation costs and ongoing project status in order to drive process improvement.

"In working with ULG, we were delighted to find that they offered a different kind of service tailored to our unique business needs. We didn’t have to alter our processes to fit into a restrictive structure."

- CRO director of Safety and Pharmacovigilance

Chapter 2

THE SOLUTION

The management team saw an opportunity to streamline operations, enhance quality and reduce costs by partnering with an LSP who could provide a centralized technology platform and manage all translation projects worldwide.

After reviewing their options, the CRO chose ULG (ULG) as the solution provider.

ULG’s language services specialists recommended an efficient solution that combined high-quality language translations and an industry-leading technology platform.

“In working with ULG, we were delighted to find that they offered a different kind of service tailored to our unique business needs,” said the Director. “We didn’t have to alter our processes to fit into a restrictive structure.” ULG assigned a dedicated team to partner with the CRO’s safety specialists to create a workflow that met their specific needs. The teams worked together to:

  • Define and set up automated workflows to streamline all data collection, translation and production processes
  • Implement centralized translation memories and glossaries which were set up and maintained on the CRO’s behalf by ULG to improve translations, reduce costs and increase consistency
  • Identify legacy content and convert it into reusable information components stored in a dedicated language repository
  • Create automated style sheets to streamline final reports
  • Launch a secure, Web-based project management portal for quoting, submission and tracking, accessible by all authorized employees
  • Provide training and support for end users of the system
  • Provide daily status reporting and “traffic light” early alert systems to keep projects running smoothly and on time

Chapter 3

PROVEN RESULTS

The CRO experienced significant cost reductions and time savings as a result of its new language solutions program, including:

  • Time savings of 50 percent in translation turnaround times as a result of standardizing and automating the submission of projects
  • Cost savings of 23 percent by taking advantage of ULG’s translation memory and glossary tools and the standardization of Adverse Events (AE) templates
  • Consistent 24-hour turnaround time on translations of the four core elements
  • A proactive communication program to alert the team of any potential issues requiring attention
  • Zero language quality issues, as all work is managed according to ULG’s Lean and Six Sigma processes
  • Improved cost controls as a result of consistent pricing on all submitted projects
  • A new language services technology platform that required no upfront capital investment from the CRO

The foundation of these comprehensive clinical trial translation services is ULG’s deep and broad medical linguistic resources, combined with its ability to provide dedicated project management resources and smart technology solutions.

 

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