Linguistic Validation Innovators
Patient Reported Outcomes (PRO) instruments are increasingly vital to the success of conducting global clinical research. At Corporate Translations, we understand the complex nature of the regulations surrounding the translation and linguistic validation of PRO instruments, and have developed efficient and effective procedures as a result. Approximately half of our business is in the arena of linguistic validation, and we have produced validated translations of more than 500 PRO instruments in over 170 languages and dialects. We provide linguistic validation services to such clients as Pfizer, Novartis, Eli Lilly, Amgen, and Schering-Plough.
Our Linguistic Validation Process Focuses on Quality, Speed, and Scientific Rigor:
- Our rigorous linguistic validation methodology meets or exceeds all guidelines provided by the FDA and ISPOR.
- Corporate Translations is the only known company to have achieved ISO 9001:2008 certification specifically for the linguistic validation of PROs.
- Our methodology includes additional translation reviews performed by instrument developers, internal survey research experts, and client subsidiaries.
- Our speed is unparalleled in the industry, and our efficient process allows us to offer turnaround times which are weeks shorter than those of our competitors.
Each Quotation or Project We Undertake Begins with Research and Preparation:
- We eliminate redundancies by thoroughly researching each instrument’s translation history before initiating any new project.
- Our comprehensive research team is pleased to connect our clients with existing translations and ease the process of working with instrument developers and obtaining permissions for use.
- Our full-time research department performs research on behalf of our clients, publishes manuscripts, and presents posters and abstracts at conferences such as ISPOR and ISOQOL.
- Our president, Mary Gawlicki, is a member of the ISPOR PRO Task Force on Changing Culture or Language of an Application, a team focused on identifying and solving problematic issues surrounding PRO translation.
At the End of Each Linguistic Validation Project We Provide:
- Comprehensive Linguistic Validation report suitable for regulatory submission
- Final translations and back-translations
- Notarized Certifications of Accuracy for each instrument and language
