Translation & Linguistic Validation Services
PATIENT FOCUSED, QUALITY DRIVEN
As pioneers in the field of translation and linguistic validation of health outcome measures, we uphold our reputation for high quality work, attention to detail, and excellent customer service on every project.
We offer a wide range of services for your studies:
COA Development Consultation: Translatability Assessment
COA measures are most-often developed in English, and certain concepts may not translate easily or prove to have limited or no conceptual equivalence in other cultures. Translatability Assessment refers to the proactive process of identifying such issues as early in the instrument development process as possible. Concept definition, also referred to as concept elaboration, goes hand in hand with this process and serves to define terminology and intended meaning of items providing acceptable translation alternatives, unacceptable translation alternatives, and offering solutions for specific translation issues within linguistic families. Engagement with instrument developers is crucial at these key stages to ensure the intended meaning of each item is conveyed to produce translated items that say what they mean and mean what they say.
COA Translation & Linguistic Validation
Patients live with their disease, treatment or conditions. As such, patients themselves provide the most informative, useful perspective on a questionnaire's (COA’s) content. FACITtrans’ full COA translation methodology specifically requires interviewing patients with the translated questionnaire and asking them questions about the items in order to fully capture the target-language patient’s voice and experience. This process, called “cognitive interviewing”, helps ensure the final translated versions are as conceptually and culturally equivalent as possible. These steps seek to affirm the linguistic validity of the translated measure and ultimately strengthen our clients’ ability to understand the multinational patient perspective and obtain a label claim from internationally-collected clinical trial data.
At FACITtrans, we believe capturing the patient voice is imperative. As highlighted on our History page, our team was part of the original publication of these now widely-accepted translation approaches. For over 20 years our mission has been Providing A Voice for Patients Worldwide. We deliver on this promise to patients and our clients every day.
Translation of Consent Forms and Protocols
As longtime members of an academic research community we are well versed in the administrative and legal requirements of clinical trial research.
We offer tailored translation approaches to handle the standardized documentation such as diaries, event logs, or legal/administrative documentation like consent forms or protocols require simpler translation methods but with rigorous quality and semantic monitoring.
In-trial Interviews
High-quality qualitative research depends on experienced interviewers who can engage with participants professionally while maintaining study integrity. Through our In-trial Interviews – Interviewer Services, FACITtrans coordinates trained interviewers to support structured interviews as part of clinical and outcomes research.
All interviewers are carefully vetted by FACITtrans for professionalism, ethical awareness, confidentiality and sound judgment. Clients provide study-specific training to ensure alignment with research protocols, while FACITtrans manages scheduling and coordination with participants. Interview recordings are securely transferred to the client’s designated platform, and training for clinical sites can also be supported when needed.
Interview Transcription and Translation
Conducting interviews in other countries, and need transcripts of the interview in English?
We have years of experience transcribing interviews and translating the interviews into English for you. Quality checks are scheduled at each step of the process.
eCOA Adaptation and Migration
Electronic Clinical Outcome Assessment (eCOA) captures data electronically in clinical trials. COA measures that were developed for pen and paper administration must be adapted for electronic delivery, and often some adjustments to the measure's instructions or layout are needed.
FACITtrans’ eCOA expertise includes:
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Adapted over 90% of FACIT scales into as many as 70 languages
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Adapted over 15 non-FACIT instruments into as many as 30 languages
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Currently supporting >15 pharma clients & eCOA vendors
FACITtrans eCOA services:
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Instruction adaptation for clear patient comprehension
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Adapt language to fit context of device
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Multilingual migration to XML, JSON and CSV formats
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Screenshot proofing across variety of electronic platforms
We look forward to serving your study needs. Learn more and Contact us to get started!
Frequently Asked Questions
FACITtrans is ISO 9001:2015 and ISO 17100:2015 certified.
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