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.
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 Propio, 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
The Solution
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 Propio’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 Propio’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 Propio’s deep and broad medical linguistic resources, combined with its ability to provide dedicated project management resources and smart technology solutions.
Proven Results
Propio’s efficient approach of combining translation proficiency with a customized delivery platform resulted in completion of the SBC documents and regulation compliance in advance of the enrollment deadline.
Propio’s unique translation methodology, proprietary technology and utilization of translation memory saved the health insurance company over 40 percent versus traditional translation services.
Over the course of the three-month project, Propio efficiently translated more than 30,000 pages related to the SBC mandate into all requested languages.
The new information delivery platform created by MCS was able to provide robust tracking information for document status and completely auditable delivery reports.
Propio’s dual expertise in the healthcare market—in both managing the entire information delivery chain and in translations specifically for the healthcare market—makes it a one-stop shop for technology-enabled communications, production, delivery as well as compliant, integrated translation services.
Propio routinely works with extremely high volume, highly confidential data and is able to quickly scale to meet the needs of translating such content, while also providing healthcare companies with the technology infrastructure they need to meet every compliance and audit requirement under the ACA.
