Linguistic Validation 2.0
The life sciences industry relies on effective linguistic validation services to ensure the quality and validity of translated clinical outcome assessments (COAs), such as Patient-Reported Outcomes (PROs), Clinician-Reported Outcomes (ClinRo), Observer-Reported Outcomes (ObsRo), and Performance-Outcomes (PerfO), as well as multilingual international clinical trials. Accurate language translations obtained through sound and robust linguistic validation processes are mandatory regulatory compliance requirements for international clinical research and development. This is why pharmaceutical companies and contract research organizations (CROs) spend millions each year conducting linguistic validation (high quality document translation) for a range of clinical activities. However, effective 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. The conventional process involved to conduct effective linguistic validation is not only costly but also time consuming.
Today’s pharmaceutical companies and CROs desperately need a modern solution to manage linguistic validation to achieve higher language localization quality performance while at the same time better meeting international regulatory compliance, hence, Linguistic Validation 2.0.
Stepes has redefined linguistic validation (LV) services using a modern, cloud-based translation management workflow that’s centralized and streamlined, enabling our medical linguists and subject matter experts to confidently perform translation and linguistic review across all devices. Our linguistic validation solutions leverage the latest AI and harness the power of human and machine capabilities. We empower our professional, highly experienced native life sciences linguists and subject matter experts like doctors, clinicians, and healthcare professionals to most confidently perform linguistic validation for the best ROI. Our modern online, AI-powered translation management technologies enable doctors, clinicians, and other medical professionals to confidently and conveniently review and edit translations across all devices for results that’re better than ever. Stepes helps the world’s leading pharmaceutical and CRO companies obtain the best linguistic validation with improved performance at reduced localization cost.
The Authority in Linguistic Validation
Stepes has years of experience translating for the life science industries, including pharmaceutical, contract research, biotech, and medical device companies. We employ some of the best professional in-country linguists and life sciences subject matter experts to deliver linguistically accurate and technically precise clinical translations with unrivaled localization performance. Stepes’ next-gen AI powered translation technologies are purposely designed to automate many of the unneeded manual human touch points within the clinical translation lifecycle to improve language accuracy while making the entire linguistic validation process more efficient. As an ISO 9001:2015 and ISO 13485:2016 certified company, Stepes has the tools, knowledge, and experience to deliver top notch linguistic validation services our clients depend on for global success. We set the standards for simpler, faster, and better linguistic validation services. Talk to our sales today and learn how Stepes can raise your linguistic validation performance to a whole new level of accomplishment.
Linguistic Validation for Clinical Trials
Clinical trials are increasingly conducted internationally with patients, investigators, trial organizers, and even doctors and clinicians speaking 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: 1) better patient sampling to cover different ethnic groups, 2) spend reductions with lower labor cost in overseas markets, and 3) enhanced international market entry once the drugs are approved by regulatory authorities such as the FDA, NMPA, and EMA. Stepes is the authority for professional linguistic validation for clinical trials. Our cloud-based, lean localization model provides a much-needed alternative to old-fashioned, ad hoc, and costly linguistic validation services. Better yet, Stepes helps pharmaceutical and CRO companies organize and manage multilingual documents using our state of the art online virtual data rooms. To learn more about Stepes expert clinical trial translation services, please click here.
Linguistic Validation for COAs
Clinical Outcome Assessments (COAs) is 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 process called linguistic validation. Stepes has the linguistic expertise and field experience to help the world’s leading pharmaceutical and CRO companies conduct COA linguistic validation with quality and speed. We have the linguistic subject matter experts and best-in-class processes and technologies to ensure the highest language quality results for all your clinical assessment documents.
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 that places more importance on the opinions, comments, and complaints by patients, namely patient-reported outcomes (PROs), compared to those coming from clinicians, caregivers, and trial observers. This is why it’s all the more important to accurately translate PROs using linguistic validation processes in order to obtain drug approvals from regulatory authorities in international markets. With Stepes, we have the linguistic subject matter experts and localization best practices to ensure both efficient and quality linguistic validation for all your patient reported outcomes across languages.
Linguistic Validation for Clinician-Reported Outcomes (ClinRo)
A clinician-reported outcome (ClinRO) assessment is designed to measure the status of patients’ health as well as 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. Pharmaceutical companies and CROs spend millions conducting clinical trials and the last thing they want is to work with an average translation company to translate these clinician-reported outcome assessment documents. This is why you need Stepes, the language industry leader for professional linguistic validation for a variety of COA assessments such as Clinician-Reported Outcomes (ClinRO), Observer-Reported Outcomes (ObsRo), and Performance-Outcomes (PerfO).
How It Works
Stepes streamlines professional linguistic validation for multilingual clinical trials covering a variety of healthcare and therapeutic areas. Our life sciences translation best practices are designed for simpler, faster linguistic validation of Clinical Outcome Assessments (COAs) for results that’re better than ever.
The first step of our linguistic validation is to translate the clinical documents with two independent life sciences linguists with the right subject matter knowledge matching the target therapeutic field of study using a process called TEP (translation, editing, proofreading.) These in-country native linguists must be supported by subject matter specific terminology glossary and automatic consistency checking tools to ensure linguistic consistency and technical accuracy of the translated materials.
Once the forward translations are completed by two independent linguists, the resulting translations are systematically compared and reconciled by a third linguist (translation reviewer) with the right specialization in the study’s subject matter area. The goal is to identify and fix all translation quality issues such mistranslation, omissions, inconsistencies, and other translation errors (including cultural misinterpretations) as well as readability issues to produce a target translation.
As the name suggests, back translation is the process of translating the translated content back to its original source language. For linguistic validation in clinical trials, this is the step to translate the reconciled translation back its source language. Depending on the requirements, back translation may be performed by one or two independent linguists who have never seen the original source document. This will allow for unbiased back translation results.
Translation Accuracy Validation and Harmonization
Once the back translation is complete, a qualified linguistic validator is engaged to review the back-translated content against the original source documents to identify any technical accuracy and consistency issues. The validator will work with the translators, project managers, and trial investigators to harmonize the translation and produce the final linguistically validated content.
The harmonized translations are then used with patients by the trial investigators in the target language to evaluate if the patients interpret the data and respond to the questions in the same way as the patients in the original source language. This process is often referred to as cognitive debriefing.
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 pharma specialists to produce the more optimal output that meets regulatory compliance requirements. However, traditional translation solutions, processes, and tools are overly complicated, leading to less desirable results. Stepes revolutionized linguistic validation by making the entire localization process seamless across all platforms and devices.
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