Effective linguistic validation services are essential to ensuring the quality and validity of translated clinical outcome assessments (COAs), as well as multilingual international clinical trials. Accurate medical translations are a mandatory regulatory compliance requirement for international clinical research and development.
Linguistic validation is a complicated undertaking involving medical terminology management, forward translation, linguistic harmonization, back translation, and language reconciliation by professional life science linguists and subject matter experts (SMEs) such as doctors and clinicians.
CSOFT’s medical linguists and subject matter experts like doctors, clinicians, and healthcare professionals are dedicated to delivering linguistic validation services for the best possible ROI.
Proven Linguistic Validation Expertise
CSOFT brings years of experience to our medical translation services across the life science industries, from pharmaceutical, clinical research, and biotech to medical device manufacturing. We employ professional in-country linguists and life science subject matter experts to deliver linguistically accurate and technically precise clinical translations with an emphasis on medical localization performance. As an ISO 9001:2015 and ISO 13485:2016 certified company, CSOFT has the tools, knowledge, and experience to deliver the top-notch linguistic validation services our clients depend on for global success.
Linguistic Validation for Clinical Trials
Clinical trials are increasingly conducted internationally, with patients, investigators, trial organizers, and even doctors and clinicians who all speak different languages. As a result, many of the clinical studies, research reports, trial sponsor materials, and patient documents such as ICFs (informed consent forms), PROs (patient reported outcomes), and patient questionnaires must be accurately translated and validated.
Multilingual clinical trials serve several purposes: better patient sampling to cover different ethnic groups; spending reductions with lower labor cost in overseas markets; and enhanced international market entry once the drugs are approved by regulatory authorities such as the FDA, NMPA, and EMA.
Linguistic Validation for COAs
Clinical outcome assessments (COAs) are a fundamental component of the clinical trial lifecycle. COAs document the benefits and risks of a treatment reported by the patient, clinicians, or trial observers within a given clinical trial.
For multilingual clinical trials, COAs conducted in other languages must be accurately translated and validated through a rigorous linguistic validation process. CSOFT’s global network of translators offers the linguistic and in-field experience to help the world’s leading pharmaceutical and CRO companies confidently conduct COA linguistic validation.
Translating Patient-Reported Outcomes (PRO)
Within the life science industry, patient-centered clinical solutions and treatment systems are rapidly gaining momentum. There is a growing trend in modern clinical trials to give importance to patient opinions, comments, and complaints– namely, patient-reported outcomes (PROs), as opposed to reports from clinicians, caregivers, and trial observers.
This trend makes it even more important to accurately translate and linguistically validate PROs in order to effectively obtain drug approvals from regulatory authorities in international markets. CSOFT’s linguistic subject matter experts and localization best practices ensure both efficient and high-quality linguistic validation for all your patient reported outcomes, in over 250 languages.
Linguistic Validation for Clinician-Reported Outcomes (ClinRo)
A clinician-reported outcome (ClinRO) assessment is designed to measure the status of patients’ health and define end-point treatments and the benefits of medical interventions for patients such as their physical feel, function, or survival in clinical trials. These assessments must be accurately translated through qualified linguistic validation processes to ensure regulatory compliance and the eventual approval of the related drugs or drug therapy.
When pharmaceutical companies and CROs invest millions of dollars to conduct clinical studies, top-quality translation is crucial to delivering these clinician-reported outcome assessment documents. CSOFT is a language industry leader in professional linguistic validation for a variety of COA assessments including Clinician-Reported Outcomes (ClinRO), Observer-Reported Outcomes (ObsRo), and Performance-Outcomes (PerfO).
Cognitive debriefing is an important step in the linguistic validation process, where a research tool or patient questionnaire, like a patient reported outcome (PRO), is tested on a small group of members of the target patient population to ensure that on a conceptual level, the respondents understand the translated questionnaire content as the same as the original. This step is crucial to the linguistic validation process as any misunderstanding or confusion in the interpretation of the questions could result in regulatory rejection or worse, endanger patients’ lives as they lack the fundamental understanding of their treatment.
Linguistic Validation with Medical Experts
Quality linguistic validation services must be performed by professional linguists working together with medical subject matter experts such as physicians, clinicians, and pharmaceutical specialists to produce optimal output that meets regulatory compliance requirements.
Our linguistic validation team experience in the following areas and many others:
Over the past 16 years, CSOFT has built our global network of medical professionals and research associations which provides our team with in-depth expertise. This expertise is then leveraged for each COA project we deliver to our clients.
CSOFT’s linguistic validation process is compliant with both the U.S. Food and Drug Administration PRO guidance documentation, and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Good Practice recommendations.
Key Steps of Linguistic Validation Project Cycle:
- 1, Preparation
- 2, Forward Translation
- 3, Reconciliation
- 4, Back Translation
- 5, Back Translation Review
- 6, Harmonization
- 7, Clinician & Sponsor Review
- 8, Cognitive Debriefing
- 9, Review of Cognitive Debriefing
- 10, Proofreading
- 11, Final Report