Clinical Trial Translations for All Phases of the Development Cycle
Precision clinical trial translation solutions for the global clinical trials market from qualified, in-country subject matter experts and linguists
End-to-End Clinical Trial Translations
Clinical trials account for an enormous portion of the investment required to bring drug therapies, medical devices, and other innovative medical treatments to market in any country, making clinical trials translation solutions necessary when conducting trials across languages. For pharmaceutical and medical device companies and CROs, expanding in overseas markets, clinical trial translation is crucial to meet local regulatory requirements. Inaccurate translation of clinical trial materials risks regulatory viability in the target market, as well as potentially endangers patient safety and drug efficacy, making precise, high-quality translation an essential priority for all stakeholders involved.
CSOFT Health Sciences’ global network of in-country linguists and clinical trial translation specialists enable clear, cost-effective, and consistent translations for all document types for phase 0-IV of the clinical process and remote clinical trials. From informed consent forms for trial participants to investigator’s brochures (IBs), our subject matter experts ensure the highest possible quality with rapid turnaround through the help of world-class translation tools and processes.
Our Tools and Methodologies
Clinical Trial Interpretation Services
With an increasing number of clinical trials being conducted in multiple countries and across languages, it’s important that patients of all backgrounds are provided with accurate and professional medical interpretation services. Professional, high-quality, and accurate medical interpretation is critical in the life sciences to ensure mutual understanding between the patient and healthcare professional, and to enable patients from diverse backgrounds to make informed decisions in regard to their health, as well as understand the associated risks for participating in a clinical trial.
CSOFT Health Sciences provides expert clinical trial interpretation solutions in over 250 languages. Our team of professional medical interpreters have experience with both in-person interpretation services as well as remote interpretation, including over-the-phone interpretation (OPI) and video-remote interpretation (VRI).
Learn more about our clinical trial interpretation services.
Multilingual Clinical Trial Translations
Today, a growing number of clinical trials are conducted globally, making multilingual clinical trial translations an essential part of the clinical trials process for sponsors and researchers. From contract research organizations and sponsors to institutional review boards and clinics, CSOFT Health Sciences’ 10,000+ professional medical translators have the linguistic and regulatory expertise and qualifications to help organizations achieve international compliance.
We have experience translating:
Endpoint Adjudication Translations
In endpoint adjudication, a blind committee of experts, known as Clinical Event Committees (CEC) or Endpoint Adjudication Committees, independently evaluate clinical events from a clinical trial and adjudicates them with predetermined event classification criteria, reducing potential bias and increasing the validity of trial outcomes. As more and more clinical trials are conducted in countries where English is not the primary language, the need for highly accurate translations of both endpoint adjudication and source case documents with fast turnaround times are vital for successful clinical trials. CSOFT Health Sciences’ linguists have a minimum of 7 years’ experience to ensure accurate translation of endpoint adjudication documentation for regulatory compliance.
Learn more about our endpoint adjudication translations.
Clinical Trial Protocol Translations
Clinical trial protocol translations enable sponsors and CROs to comply with global regulatory standards and communicate the objectives of a clinical trial to patients in multiple languages. Clinical trial protocols are crucial documents that aim to describe the objective, study design, safety measures, organization, and other important aspects of how a trial will be conducted, meaning that translations must be completed with tight turnaround times and to the highest degree of accuracy. For companies conducting clinical trials overseas and in compliance with global regulatory standards, translations for clinical trial protocols may be required for approval. With a global network of linguists and subject matter experts, CSOFT Health Sciences offers cost-effective protocol translation in 250+ languages.
Learn more about our clinical trial protocol translations.
Clinical Trial Dossier Translations
Clinical trial dossiers are a crucial collection of documentation that is submitted to European Union regulatory bodies to gain authorization for conducting clinical trials in Europe. New EU regulations require translations for all types of documents included in the dossier to successfully conduct trials in multiple EU countries. For anyone working in the space of clinical trials, ensuring that documents in the dossier such as clinical trial applications (CTAs) and clinical outcome assessments (COAs) adhere to EU standards and enable successful patient recruitment and retention is crucial. CSOFT Health Sciences specializes in high quality medical translation and localization solutions for clinical trial dossiers, with additional expertise in supporting patient engagement with patient recruitment translations, patient-reported outcomes (PROs) translations, informed consent form translations, and more.
Learn more about our clinical trial dossier translations.
Patient Portal Translations
Patient portals are emerging as a leading patient communication and patient engagement solution in both the healthcare and clinical trials sectors. These platforms enable 24-hour access to crucial health information and allow patients to view and submit important medical or clinical trial documentation, such as questionnaires and recruitment material. To reach patients on a global scale and effectively communicate with patients from diverse backgrounds, accurate translations for patient portals are imperative. CSOFT Health Sciences’ global network of over 10,000 linguists and subject matter experts have experience with high quality translations of patient-facing materials and digital health platforms. In support of international clinical trials and to uphold patient retention and recruitment, our patient portal translations enable companies and healthcare providers to reach new markets, end users, and patient populations.
Learn more about our patient portal translations.
End-to-End Translation Coverage for Full Range of Therapeutic Areas
As well as dermatology translations, CSOFT’s medical translation and localization coverage expands across a full range of clients, therapeutic areas, and treatment settings. Whether you are a hospital seeking for medical communication support in a related area such as psychiatry translation, psychology translation, geriatrics translation, men’s health translation, or women’s health translation, or a research organization recruiting patients for clinical trials, CSOFT’s end-to-end localization support covers an extensive range of conditions and therapies across disciplines.
Learn more about our comprehensive coverage for therapeutic areas here.
Anesthesiology translations are crucial to provide continuous medical care to patients before, during, and after surgical procedures. To access global markets, instruments such as anesthetic vaporizers, laryngoscopes, and endotracheal tubes along with the materials and documents required to operate and sell this equipment must be translated and localized. CSOFT Health Sciences provides translation and localization solutions tailored for clients worldwide through our global team linguists and medical subject matter experts. We provide translations for a full range of content, documents, and materials for medical professionals in the anesthesiology field.
Learn more about our anesthesiology translations
With obesity rates surging, bariatrics translations are becoming essential for medical professionals, suppliers, and manufacturers in bariatrics field to help reduce obesity across the globe. To access foreign markets, bariatrics instruments such as bariatric forceps, hysterectomy clamps, and needle holders along with the materials and documents required to operate and sell this equipment must be translated and localized.
CSOFT Health Sciences provides translation and localization solutions tailored for clients worldwide through our global team linguists and medical subject matter experts. We provide translations for a full range of content, documents, and materials for medical professionals in the bariatrics field.
Learn more about our bariatrics translations.
Real-World Data Translations
Real-world data translations are critical to enabling companies and researchers to understand and address patient needs in the modern world. Real-world data (RWD) is medical and health knowledge collected outside of randomized clinical trials or the laboratory, and includes data from electronic health records, patient self-reports and surveys, and disease registries, as well as wearable health technologies and census data. These patient-centric metrics help pharmaceutical, medical device, and other industry groups to best serve diverse patients across languages. With a global network of over 10,000 linguists and medical subject matter experts, CSOFT Health Sciences is experienced in working with life science companies involved in RWD collection and application in healthcare research.
Learn more about our real-world data translations.
Medical Wearables Translation
Medical wearables translations are essential for medical device companies launching wearable medical devices to patients around the world. Medical wearables are medical devices that are worn on a patient’s body to track vital signs to provide in-time monitoring of medical conditions and even notify patients and their healthcare teams about risks. Just as fitness trackers have taken over the commercial fitness world, wearable health technology and medical monitoring devices are expected to help revolutionize data tracking for healthcare workers and their patients. Medical wearables use advanced medical technology including ECG and blood pressure monitors, biosensors, and fall detection.
Whether medical wearables are used in decentralized clinical trials to monitor patient outcomes, to help patients recover after surgery and into rehabilitation programs, or to improve outcomes in hospitals, medical wearable translations ensure that these advances are accessible for every patient. From software localization and good manufacturing practice (GCP) to multilingual patents, our experts help companies advance health for the highest ROI. CSOFT Health Sciences’ global team of 10,000 in-country linguists, subject matter experts and software engineers is experienced in providing accurate and efficient translations for medical wearables and other medical devices.
Learn more about our medical wearables translation.
CSOFT Health Sciences has developed a process for quality assurance to ensure that every medical translation project meets quality standards in a cost-effective and timely manner. We are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 to ensure our customized solutions meet global regulatory requirements. Our subject matter expert linguists have a minimum of 7 years’ experience and work with in-country reviewers and project style guides to meet industry standards. And through our innovative cloud-based technology, CSOFT offers an online translation management ecosystem for one central location to leverage both translation memory as well as terminology management in real time. Every step of the way, CSOFT has you covered.
Learn more about our quality assurance process.
With over 20 years of experience in medical translation, CSOFT Health Sciences understands the importance of data security to our clients, and we take nothing for granted when confidentiality is a concern. Our well-documented and fully traceable information data security policies, checklists, and quality records leverage best practices of ISO 27001, and are designed to keep everything from source data to translations protected. From our 24/7/365 data monitoring and advanced encryption to our access control measures, you can be certain that your project data is safe from start to finish.
Learn more about how CSOFT prioritizes data security.