Linguistic Validation

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Effective linguistic validation services are essential to ensuring the quality and validity of translated clinical outcome assessments, as well as multilingual international clinical trials. Accurate language 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 hominization, back translation, and language reconciliation by professional life science linguists and subject matter experts 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 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 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) and PROs (patient reported outcomes) 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 therapeutic 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 opinions, comments, and complaints of patients themselves – 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 any set of 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 treatment benefits of medical interventions on the 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 treatment.
When pharmaceutical companies and CROs invest millions of dollars to conduct clinical trials, 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).

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:

  • Oncology
  • Hematology
  • Cardiovascular
  • Respiratory
  • Central Nervous System (CNS)
  • Gastroenterology
  • Inflammation
  • Immunology
  • Infectious diseases
  • Metabolic diseases
  • Rare diseases
  • Vaccines

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.

devices
Cuestionarios PRO
Cuestionarios ClinRO
cro
eCOA/ePRO
biotech
Diarios del paciente

Our Methodology

CSOFT’s linguistic validation process is in compliance 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.

Pasos clave de un proyecto de validación lingüística:
  • Face Validity Assessment
  • Dual Forward Translation
  • Back Translation
  • Harmonization Process
  • Patient Recruitment
  • Cognitive Debriefing
  • Back Translation
  • Validation Reports