Professional Clinical Outcome Assessment Translation
Stepes (pronounced /’steps/) provides best-in-class clinical outcome assessment translation services and linguistic validation in Spanish, Chinese, Hindi, and many other languages. We help CRO and pharmaceutical companies achieve multilingual clinical trial success, one accurately translated clinical outcome assessment at a time.
Clinical Outcome Assessments Translated Right
Are you a contract research organization (CRO), pharmaceutical sponsor, healthcare organization, biotechnology firm, or medical device company looking for a reliable language translation agency to translate your clinical outcome assessments with accuracy and efficiency? Then look no further than Stepes. We provide comprehensive clinical trial translation services in Spanish, Hindi, Chinese, and all major Asian, European, and Latin American languages. Stepes has the linguistic resources, localization best practices, and cutting-edge language technologies to deliver solid ROI for all your clinical trial document translation needs. Our professional COA translation process includes forward translation, back translation, linguistic reconciliation, and expert review. Better yet, our modern, cloud-based localization workflow automates the entire COA translation process for the best efficiency.
Patient Reported Outcome (PRO) Translations
Patient Reported Outcomes (PROs) are an integral component within precision medicine testing processes to assess and measure the efficacy and effectiveness of the drug in question or going through clinical trial. When it comes to multilingual clinical trials, PROs must be accurately translated to meet stringent new drug approval requirements by the FDA and international medicine regulatory authorities. Unlike other types of document translation efforts, PRO translations follow a well-defined workflow process called linguistic validation that consists of mandated linguistic production procedures. These include: forward translation by two different linguists, reconciliation by a third linguist, back translation of the reconciled result back to the source language, final expert linguistic review to ensure the translated content most accurately matches the source language version.
Observer Reported Outcome (ObsRO) Translation
Observer Reported Outcome (ObsRO) assessments are usually performed by care givers who are non-medical professionals or family members who are able to observe the patient overall health conditions such as cognition, lethargy etc. to a test medicine. These ObsRO assessment reports are sometimes written in non-standard formats, making them difficult to translate uniformly. Stepes has developed a streamlined process, allowing our team to faithfully translate ObsRO reports to ensure the correct evaluations and observations are captured. Our COA translation services follow the same best practices for observer reported outcome assessments in Spanish, Chinese, Hindi, and a variety of Asian and European languages. We’re able to translate all ObsRO file formats such as MS Word, scanned PDF documents and more. In addition to language translations, Stepes also provide professional desktop publishing services (DTP) to format the translated ObsRO reports so they look professional.
Clinician Reported Outcome (ClinRO) Localization
As a counterpart to our localization solutions for ObsRO, Stepes provides expert ClinRO (clinician reported outcome) translation services to support CRO companies, drug investigators, and pharmaceutical sponsors conducting international multilingual clinical trials. Depending on our clients’ requirements, we can provide full or partial linguistic validation services for ClinRO assessments to meet our customer’s project turnaround and budget requirements. Clinician reported outcome assessments are easier to translate compared to PROs or ObsROs because they’re completed by trained health care professionals that follow the same consistent format and style. Stepes provides both translation and multilingual publishing services for ClinRO in Spanish, Chinese, Arbaic, Hindi, and all Asian and European languages.
Performance Outcomes (PerfO) Translation
Are your conducting clinical trials in overseas markets and need your Performance Outcomes (PerfO) assessments translated for FDA submission or regulatory compliance? Then look no further than Stepes. We have the professional linguistic resources, subject matter expertise, and language technologies to confidently translate your PerfO documents with quality and speed. Stepes is an ISO 9001:2015 and ISO 13485:2016 certified translation company so you can count on us to deliver the most reliable and accurate performance outcome translations. We’re so confident you’ll like our services that we offer complete customer satisfaction guarantee in terms of quality, speed, and services. Don’t just take our word for it, try our clinical outcome assessment translation services today and see how Stepes can accelerate your multilingual clinical trial success in all languages.
Linguistic Validation
Stepes is a leader in modern linguistic validation on the cloud. Old fashion linguistic validation workflows involve many unneeded manual touch points that invariably slow down the process in addition to higher cost and inconsistent results. Offline translation processes are also less secure, opaque, hard to track and manage. Stepes has redefined linguistic validation to a modern online model, allowing our clinical trial clients to gain full process visibility in real time and monitor progress through each stage of language translation lifecycle. The result is a much more reliable translation process that reduces or eliminates uncertainty. To learn more about Stepes linguistic validation services, please click here.
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