Trial Master File Translated Right
Stepes helps CRO companies, investigators, and their pharmaceutical sponsors translate Trial Master Files (TMF) in Chinese, Spanish, Hindi, and other languages so they can confidently engage with local inspectors for international regulatory compliance.
Accurate eTMF Translations for International Trial Success
Are you a CRO or clinical trial sponsor in need of translating electronic Trial Master File (eTMF) documents between English and Chinese, English and Spanish, or English and Vietnamese? Then you’ve found the perfect language service partner for all your eTMF and medical trial translation needs. Stepes has an exceptional team of multilingual clinical linguists and subject matter experts as well as the latest linguistic validation technology solutions to ensure your eTMF documents are translated with accuracy and speed. We lead the clinical translation field with next-gen AI-assisted translation workflows that achieve better linguistic quality and consistency, while reducing project turnaround time and localization costs.
Translating Your eTMF Documents on the Cloud
Our electronic Trial Master File translation solutions take advantage of the cloud and modern digital technologies to deliver the best localization results. The FDA, the European Medicines Agency (EMA), and other international regulatory authorities now require healthcare providers to document and store clinical records electronically rather than on paper. Stepes is one of the first translation companies to move the entire localization workflow onto the cloud. Our intelligent online translation management ecosystem allows for improved cost efficiency, scalability, collaboration, analytics, and clinical outcomes across multiple languages. In addition to providing end-to-end eTMF translation solutions, Stepes also allows our CRO and pharma clients to easily search for multilingual clinical documents online by simply entering a search string in any language. Talk to our eTMF translation specialists today and learn how Stepes can help your organization achieve significantly improved ROI for all your Trial Master File translation needs.
Essential Documents Translated Right
The International Conference on Harmonization (ICH) has developed stringent requirements for the registration of pharmaceuticals for human use. The Good Clinical Practice (GCP) mandates that the design, performance, monitoring, auditing, recording, and reporting of clinical trials must be clearly and accurately documented in the Essential Documents, a major component of the Trial Master File. For multilingual clinical trials, this means the Essential Documents must be accurately translated and made available to local inspectors. Stepes has the experience and technical solutions translating all Essential Documents with certified accuracy and speed. To obtain a quote, simply drag and drop your files onto our online project port. Upon your request, our eTMF translation consultant will contact you within one hour.
Linguistic Validation
Stepes provides modern linguistic validation services as part of our comprehensive clinical trial translation solutions for CRO, pharmaceutical, and medical device companies. Unlike other translation companies that rely on outdated, offline linguistic validation processes, Stepes’ innovative, cloud-based linguistic validation model takes advantage of the latest AI and translation management automation to help our life science clients achieve significant performance improvement for all steps of the linguistic validation process. To learn more about Stepes industry leading linguistic validation solutions, please click here.
Professional Clinical Trial Translations
Stepes is a premier translation company for modern clinical trials that are conducted internationally. We help some of the top CROs and pharmaceutical sponsors succeed on a worldwide scale. Our innovative, thinking-outside-the-box solutions disrupt the orthodox approach to clinical trial localization so our clients can achieve unrivaled performance and ROI. When it comes to enterprise clinical trial translations, only “knowing how” is not enough, it also requires the translation vendor to have the experience, technology innovations, global infrastructure, and linguistic resources to deliver the most reliable results. To learn more about Stepes next-gen clinical trial translation services, please click here.
Medical Document Translation
In addition to translating eTMF for clinical trials, Stepes provides a complete suite of translation and localization solutions for a large array of medical documents for healthcare, pharmaceutical, biotechnology, and medical device companies. We have one of the largest teams of medical translators and subject matter experts in over 100 languages. We also have industry leading medical terminology management solutions so all medical terms are translated accurately and consistently across documents and languages. To learn more about Stepes full service medical document translation solutions, please click here.
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