Capture International Drug Markets with the Best Clinical Trial Translations
Finally, translating your clinical trial reports and case studies doesn’t have to be a drag on your international drug launches. Stepes’ industry-leading medical translation solutions simplify professional language services for clinical research and development so life sciences companies can accelerate global growth with confidence.
Multilingual Clinical Trials
Clinical trials are increasingly being conducted globally. According to industry studies, over 90 percent of new drugs approved in 2017 were tested outside of North America in places such as Asia, Latin America, or Central and Eastern Europe. With this trend, language translation services are an indispensable requirement for today’s global clinical trial activities. Regardless if you are a contract research organization (CRO), trial sponsor, institutional review board (IRB), or hospital system that needs professional medical translation services in Spanish, Simplified Chinese or Indonesian, Stepes has the linguistic capabilities and foreign regulatory expertise to help you navigate the intricacies of international compliance and overseas clinical studies. Stepes translates all types of clinical research documents including clinical protocols, studies, and patient consent forms.
» Talk to us today for a customized solution for your clinical trial translation needs.
At Stepes, we have built an experienced team of professional in-country medical linguists and subject matter experts who are intimately familiar with the entire process of clinical research, medical trials, and international regulatory submissions. To complement that, we’ve also developed the language industry’s leading translation technology platform to centralize and streamline the entire clinical trial localization process for unrivaled efficiency and scalability. Stepes also owns the biggest multilingual bio-medical terminology database to assist our highly trained medical linguists in consistently producing technically accurate translations for clinical trials. We support language translations in Simplified Chinese, Spanish, French, and all other major Asian and European languages.
We’re Stepes ahead in Clinical Trial Translations
You’ve invested millions, if not billions, in R&D for the development of new drugs and medical devices, and the last thing you want is to work with an average translation company for your clinical trial translation requirements. The life sciences industry is witnessing rapid changes in the way clinical trials are conducted and managed on a global scale, with more drug research conducted internationally. As a result, the need to translate your clinical publications and submission materials for the US FDA and other international regulatory authorities has grown exponentially. However, to efficiently and reliably translate this content with quality and consistency goes well beyond the capabilities of ordinary translation services. This is why you need Stepes, the language translation agency with the best-in-class processes and cutting-edge technology to the get job done with the best results.
Centrally Managing Your Multilingual Trials
Stepes offers a cloud-based translation platform so you can easily manage the day-to-day translation requirements throughout the drug development process and clinical trials. The system provides powerful translation memory and terminology searches in real time, as well as allowing you to track the progress of all translation related activities. By centrally managing all of your clinical research content in all languages on the cloud, you can significantly reduce localization efforts, optimize performance, and eliminate redundancies to achieve the most efficient and consistent business outcome for your international clinical trials.
We Translate These Clinical Trial Materials and More
- Drug Development Process Documentation
- Sample Case Report Form (CRF)
- Informed Consent Form
- Clinical Study Protocol
- Instructions for Use
- Patient Diaries/Reports
- Patient Questionnaires
- Trial Close-out Monitoring Report
- Clinical Study Report
Back Translation is a method of validating the linguistic and technical accuracy of translated materials and is often used as a quality assurance step in clinical trials and other mission-critical translation projects. Back translation is literally translating the translated content back to its source language in order to verify translation accuracy and completeness. To ensure validity, back translation must be performed by different linguist(s) other than the original translator.
Although back translation is a good practice to ensure translation quality, it’s a costly and time-consuming process because the customer usually has to pay twice for the same translation project. The good news is there are now modern solutions using machine translation (MT) with subject-matter specific terminology training to deliver high quality results for a fraction of the cost. If your organization needs automated back-translation support for international clinical trials, please contact Stepes sales for a customized solution.
Common Technical Document (CTD) Translations
Looking to register your medicines with international regulatory authorities such as China, Japan, or the European Union? One essential requirement is to professionally translate your new drug’s technical information on quality, safety, and efficacy to ensure compliance with the harmonized electronic submission and good regulatory review practices that’re widely required internationally. This is why you need Stepes. Our industry-leading, centralized document translation solution is perfectly engineered to meet the requirements of the Common Technical Document (CTD) translation standards. We have expert experience translating all five of the CTD document modules including M4Q, M4S, and M4E.
Since 2003, the CTD requirement became mandatory for pharmaceutical companies to file for new drug applications in the EU and Japan. It was also strongly recommended for the United States’ FDA and China. Before CTD, life sciences companies submitted technical documents in various formats which made it difficult for different foreign regulatory authorities to review the information for consistent approval standards effectively. This is why the ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), working with the European Medicines Agency, the US FDA, and Japan’s Ministry of Health, developed drug application specifications for the registration of medicines to be marketed across Europe, Japan, and the United States.
The Common Technical Document is divided into five modules and all of which must be adequately translated into the required languages to be eligible for harmonized electronic submission in the corresponding countries. The five modules are:
Administrative and prescribing information.
- Overview and summary of the drug’s quality, safety, and efficacy on humans.
- Quality (M4Q ) - This is pharmaceutical documentation covering chemical, pharmaceutical, and biotechnological data.
- Safety (M4S) - Preclinical documents providing objective and critical assessment of the pharmacology and toxicology evaluation of the pharmaceutical.
- Efficacy (M4E) - These are typical clinical trial documents including clinical studies, protocols, and patient reports.
Simplifying Translation Review by Medical Experts
A major advantage of Stepes clinical trials translation services is our unique ability to simplify linguistic review by medical specialists such as doctors and clinicians for quality results. Unlike other translation companies that employ over-complicated tools which are difficult to use for linguistic validation, Stepes allows life sciences experts to easily review and validate language translations on their mobile, anytime and anywhere, within a familiar messaging (chat) environment. This leads to translation results that are not only technical accurately, but also linguistically fluent for regulatory review and approval.
Proactive Terminology Management
The International Council for Harmonization (ICH) recommends proactive terminology management as part of the Good Clinical Practice (GCP). No other translation services come close to Stepes in terms of developing comprehensive technical solutions for effectively managing glossaries to ensure the most accurate and consistent quality clinical trials translations. Our wiki-based terminology management solution facilitates seamless collaboration among clinical quality assurance professionals, clinical research associates, investigators, terminologists, translators, study coordinators, language reviewers, and regulatory affairs professionals for the best business outcomes. To learn more about Stepes terminology management solutions, please click here.
A Tutorial on Better Clinical Trial Translations
Struggling with your clinical trials translations? No problem. Conducting clinical research in one language is already a challenge; the last thing you want is to manage the same clinical studies in multiple languages like Simplified Chinese, Spanish, and French. The good news is there’re many modern tools and solutions that take the pain out of managing translation services for clinical projects. Our experienced life sciences experts and linguistic professionals have spent the time to compile a list of Dos and Don’ts and best practice discussions for the most efficient language translation and localization solutions. If you are a localization manager working for Clinical Research Organizations, Bioinformatics, Contract Research Organizations, Clinical Trials, Drug Discovery, Biomarkers, Hospitals, or Biotech companies, then this how-to guide is a must read. It will demystify fuzzy theories and offer actionable insights and practical tips on delivering the best language service results for your clinical trials.
Translation Innovations for Clinical Trials
Patient Centricity Achieved
A major trend in clinical trials is the increasing focus on an improved patient experience. More and more sponsors and CROs invest in modern technologies to simplify the enrollment process and make the patient’s life easier. Remote trials powered by digital portals reduce site visits and allow patients to access trial information from their homes. This is where Stepes location-based translation services can be a game-changer. Stepes uses GPS to automatically map the locations of our pre-approved translators and dynamically assign the best linguists for patient translation services on-site, via the phone, or over video.
Data Driven Multilingual Terminology Management
Unlike most other terminology management tools on the market, Stepes is powered by TermWiki Pro (TWP), the most powerful terminology management solution for medical terminology. TWP not only supports collaborative terminology management activities, it also supports multi-level term attributes including custom defined properties such as definition, usage example, reference, and complete revision history. Professional terminology management is one of the most important requirements for quality clinical trials translations.
Digital Health & mHealth
The FDA’s 21st Century Cures Act means that digital medical technologies such as software programs and computer-aided diagnostic tools will play a major role for future clinical trials for fast-tracked approval and improved results. Mobile Health or mHealth is disrupting the medical services industry with its versatility and speed. This is why Stepes, the leader in mobile translations, is ideally positioned to provide professional human translation services on-demand for next-gen digital health solutions.
By making translation services easily accessible to bilingual subject matter experts such as doctors and clinicians in addition to professional translators, Stepes is able to deliver multilingual translations for results that are better than ever. Stepes makes it possible for language translation services to be performed anytime and anywhere on mobile phones or desktop computers alike, delivering unrivaled flexibility and scale that modern international clinical trials demand.