Translation and Linguistic Validation
of Clinical Outcome Assessments (COAs)
eLicensing and Copyright Support
COA Library & Document Management
Study Binder Formatting
Face Validity Assessment
TransPerfect’s Linguistic Validation group specializes in translating and adapting Clinical Outcome Assessments (COAs) across a variety of therapeutic areas. As the industry’s foremost experts in linguistic validation, our process is designed to ensure conceptual equivalence and cultural appropriateness in any language, minimizing time-to-market, mitigating risk, and ensuring regulatory compliance in global studies.
The complex and regulated process of adapting COA instruments for use in global research studies demands that we keep abreast of the latest guidance on linguistic validation methodology (FDA PRO Guidance, EMA guidelines, and ISPOR Good Practice recommendations). Our comprehensive COA solutions include:
Throughout the years, TransPerfect Life Sciences has identified a gap in the migration process from paper to electronic. Today, we are the leader in innovation in eCOA migration with our breakthrough technology, GlobalLink XCompare.
XCompare is our proprietary risk-mitigating technology used during the migration of validated paper COAs to electronic platforms. It reduces migration errors by 97% and speeds up review rounds by 50%. Learn more and request a free QC check of your translations here.
The future of eCOA migration is a fully complete integration that removes the need for passing technical files back and forth and rounds of review.
Applanga is a proprietary technology that connects directly to the ePRO/eCOA app itself via an API. This allows for TransPerfect to take on the full testing process and remove the ePRO vendor from that back and forth, resulting in a 2.5 times faster turnaround time and reduced project management.
TransPerfect Life Sciences enjoys strong and long-standing relationships with leading eCOA technology firms, and our close cooperation and integration capabilities mean that we have industry-leading solutions to support multilingual electronic clinical outcome assessments.
Whether your scales start as pen-paper or eCOA content, TransPerfect Life Sciences’ eCOA integration solutions can fit into your workflows.
Pen-paper and eCOA delivery each have their place, and each medium presents unique challenges and languages that must be adapted. Our automated process is the industry’s simplest to ensure that final, linguistically validated scales are properly uploaded in industry-standard formats and software specific for each eCOA vendor. Once the eCOA vendor has generated the screenshots, TransPerfect conducts an intensive testing and proofreading process to ensure no issues were introduced to the language during programming and that language expansion did not result in broken strings, formatting issues or missing text.
TransPerfect offers a systematic and industry-level standard approach to evaluate the use of electronic Clinical Outcomes Assessments (eCOAs). In compliance with industry-level standards, TransPerfect conducts face-to-face interviews with individuals who meet your inclusion criteria to assess the usability of your device and software. Our approach includes an evaluation of intuition, ease of use, visibility, readability, as well as a report on proposed improvements and recommendations. We strive to create a user-focused experience by evaluating patient feedback to improve progress tracking and patient device interaction.
Over the last 15 years, TransPerfect has built long-standing relationships with copyright holders, authors, and developers. Our COA Division has a team of experts dedicated to ensuring a smooth permissions process. Our group offers a holistic approach comprised of leveraging developer relationships and a comprehensive understanding of developer processes and procedures while keeping a clinical study’s crucial timeline milestones in mind. Transparency is paramount and systematic measures are in place to ensure our clients are in the loop and ahead of any rate-limiting factors.
After existing translated versions are obtained, our XCompare technology is applied to ensure 100% compliance and integrity of the existing measures in eCOA form.
TransPerfect Linguistic Validation provides a comprehensive suite of solutions to support rater training efforts. We offer translation and adaptation of all training materials, including those delivered by video and through interactive e-learning courses. TransPerfect has over 1,200 clinician reviewers in our network to review any ClinRO work, from neuropsychologists to urologists and almost anything in between.
Our studio services include professional subtitling as well as voiceover and dubbing using our unparalleled selection of professional voice talent and fully equipped in-house recording studios. Our experienced studio supervisors oversee each recording session and ensure that the highest standards are maintained.
In addition, for e-learning courses, TransPerfect works directly with course authors to adapt training courses with measurable goals and objectives in mind. Far from a standard word-for-word translation, TransPerfect’s global training consultants work to understand the unique goals of your course and work with carefully selected linguists to ensure that the final product is linguistically accurate, culturally appropriate, and technically sound.
TransPerfect’s 21 CFR Part 11 compliant Trial Interactive online document repository allows for web-based archiving of COAs for easy access and retrieval. It stores all clinical outcome assessments (PRO, ClinRO, ObsRO, PerfO), as well as documentation from the development of the assessments, licensing / copyright information, final (linguistic validation) reports, certifications, all relevant eCOA documentation and screenshots, final PRO Batteries, and any additional documentation in the cloud.
Files in Trial Interactive are fully indexed and searchable, and it also serves as a workflow management tool to track and manage all ongoing activities surrounding formatting projects, eCOA projects, translation projects, and the management of COA content. Available in over 20 languages, Trial Interactive is the only tool of its kind that allows users from all over the world to navigate the program in their native languages.
TransPerfect’s professional formatting teams regularly assist our clients in formatting their study binders for the administration of COAs. TransPerfect’s expert team compiles the required files in all languages, implements the required margins, headers, visit and study numbers, and footers, and formats all the required documents together to meet your study needs and ensure your binders are ready for immediate printing.
Some expressions, concepts, and terms found in COAs present challenges far greater than standard translation or copy adaptation. TransPerfect’s translatability evaluation process helps clients proactively avoid problems that may arise later in the process.
Without assessing translatability and source language in advance, problems may arise after a COA has been finalized and linguistic validation has begun, resulting in costly backtracking and repeated work.
When potentially problematic items are identified in the development stage, they can be revised, removed, replaced, or sidestepped to create a source language instrument better positioned for translation with fewer conceptual equivalence difficulties. This new approach results in a more internationally appropriate instrument as well as cost and time savings in linguistic validation.
TransPerfect conducts face validity assessments by reviewing the questions and response sets, as well as having untrained individuals complete the measure, then obtaining feedback by debriefing. This aids in the identification of problematic wording, non-pertinent information, confusing instructions, as well as conceptual ambiguity.
During this assessment, TransPerfect works closely with the developer(s) to define and clarify concepts. The evaluation also covers cohesiveness of questions to responses, and gradation differences between item response options.