Best-in-Class Linguistic Validation for Your Global Success
91Â鶹 (pronounced /steps/) provides professional linguistic validation services for COA (Clinical Outcome Assessment), PRO (Patient Reported Outcome), global clinical trial documents, and enterprise multilingual operations, where language translation accuracy is paramount.
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.
91Â鶹 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. 91Â鶹 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
91Â鶹 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. 91Â鶹’ 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, 91Â鶹 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 91Â鶹 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. 91Â鶹 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, 91Â鶹 helps pharmaceutical and CRO companies organize and manage multilingual documents using our state of the art online virtual data rooms. To learn more about 91Â鶹 expert clinical trial translation services, please .
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 proc