Clinical study translations are essential for patients across languages to participate in clinical studies and for researchers and sponsors to meet endpoints with diverse participation. Clinical studies involve clinical trials and observational studies and are central to the development of new medical technologies, procedures, and research. Whether a clinical study is helping to bring revolutionary new drugs to market or helping scientists understand how the human brain works, diverse participation enabled by clinical study translations helps reduce bias and increases the transferability of results across populations. From study-startup to endpoint adjudication, localizing clinical study materials, such as clinical outcome assessments, patient enrollment forms, and informed consent forms, is crucial in conducting an international clinical trial or observational study. CSOFT Health Sciences’ clinical study translations offer speed, cost efficiency, and quality backed by medical subject matter expertise to ensure viable, technically accurate translations of clinical trial documents in 250+ languages.
Enabling Remote Monitoring in Clinical Trials
The COVID-19 pandemic disrupted the clinical trial industry in 2020 with a need for the remote monitoring of patients. Now, remote monitoring has become a standard for conducting decentralized clinical trials. This shift has created an urgent need for the medical translation and localization of clinical trial documentation. In addition, as patients move further away from study sites, there is an even more pressing need to develop culturally sensitive and well-localized content for patient communication to build trust and drive patient engagement.
Learn more about how CSOFT Health Sciences provides solutions for remote monitoring in clinical trials.
Multilingual Clinical Trials
Today, many clinical trials are conducted globally, with over 90 percent of new drugs approved in recent years having undergone trials and testing outside of their primary markets. To compete in this new global marketplace, multilingual clinical trial translation is essential for ensuring patient safety, regulatory compliance, and the functioning of parallel operations across clinical trial sites worldwide. From contract research organizations (CROs) and sponsors to institutional review boards (IRBs) and clinics, CSOFT Health Sciences’ 10,000+ professional medical translators have the linguistic and regulatory expertise and qualifications to help organizations achieve international compliance through highly accurate clinical trial documentation translations, including:
Learn more about our clinical trial translations.
Informed Consent Form (ICF) Translation
Providing clinical trial participants with clear information about study procedures and the potential risks and benefits of a novel treatment or drug type is essential for their safety and is a firm legal requirement strictly enforced by government oversight agencies. CSOFT Health Sciences’ informed consent form translation services, a crucial aspect of translations for clinical studies, ensure that patients and their interests are protected and accounted for, regardless of their native language or location of residence.
Learn more about our informed consent form translations.
Trial Master File (TMF) Translations
Trial Master Files (TMFs/eTMFs) are used by regulatory authorities to determine compliance with Good Clinical Practices (GCP) and clinical trial protocol. TMFs and their digital format, eTMFs, are essential in the regulatory compliance process while conducting international clinical trials. As more clinical trials are conducted in countries where English is not the primary language, highly accurate and timely TMF and eTMF translations are vital to gain regulatory compliance and access new markets. CSOFT Health Sciences provides only the most precise trial master file translations at unmatched speed for the best ROI.
Learn more about our TMF/eTMF translations.
At CSOFT Health Sciences, we’re frequently asked to work on a variety of clinical documentation.
Below are some examples of documentation we specialize in:
- Phase 0 to IV Clinical Trial Translations
- Toxicology Translations
- Informed Consent FormTranslations
- Investigator’s Brochure(IB) Translations
- Case Report Form(CRF) Translations
- Pharmacovigilance Translations
- Adverse Event Reporting Translations
- Package Label and InsertTranslations
- Package Information Leaflets (PIL) Translations
- Development Safety Update Report(DSUR) Translations
- IRB Correspondence Translations
- Clinical Study Report(CSR) Translations
- Medical DocumentTranslations
- Patient Information SheetTranslations
- Patient Diaries Translations
- Summary of Product Characteristics (SmPC) Translations
- Instructions for Use (IFU) Translations
- Scientific Article Translations
Patient Recruitment Translation
The patient recruitment process is critical to conducting clinical trials to test the safety and efficacy of new drugs and medical devices. As more and more clinical trials are conducted overseas and among Limited English Proficiency (LEP) patients, using high-quality and accurately translated outreach material is vital to recruiting diverse patients to meet clinical trial goals and endpoints. CSOFT Health Sciences helps sponsors, research sites, and CROs access the patients needed for clinical trials through highly accurate patient recruitment translation in 250+ languages.
Learn more about our patient recruitment translations.
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 adjudicate them with predetermined event classification criteria, reducing potential bias and increasing the validity of the trial outcomes. As more clinical trials are conducted globally, highly accurate translations of both endpoint adjudication and source case documents are crucial for any clinical trial’s success. CSOFT Health Sciences’ global team of subject matter expert linguists and regulatory specialists will ensure your multilingual endpoint adjudication is delivered accurately and timely.
Learn more about our endpoint adjudication translations.
Other Medical Translation Services
Our end-to-end medical translation and localization services cover a range of clients, medical professionals, and treatment settings. In addition to CSOFT Health Sciences’ cost effective and timely terminology management solutions for life science companies, our global network of subject matter experts and in-country linguists, each with a minimum of 7 years’ experience in their field, specializes in a wide range of localization solutions for medical content, including:
Quality Assurance
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.
Data Security
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.