EXPERTS IN CLINICAL STUDY TRANSLATIONS

Localizing clinical outcome assessments, patient enrollment forms, and informed consent forms is a crucial step in the process of conducting an international clinical trial or observational study. CSOFT’s clinical study translations offer the speed, cost efficiency, and quality backed by medical subject matter expertise to ensure viable, technically accurate translation of clinical trial documents in 250+ languages.

Contact us now
Home 9 Clinical Study Translations

Urgent COVID-19 Clinical Trial Translations

As COVID-19 continues to impact countries worldwide years after the first transmission of SARS-CoV-2, the need for rapid yet highly-accurate clinical study translations (or clinical trial translations) for COVID-19 has increased significantly. For companies leading clinical trials for vaccines, treatments, or new drugs in response to the continuing pandemic, CSOFT Health Sciences is prepared to offer rapid translation services for COVID-19 clinical trial materials with the shortest possible turnaround.

Learn more about our COVID-19 clinical trial translations.

Enabling Remote Monitoring in Clinical Trials

COVID-19 disrupted the clinical trial industry in 2020 with an increasing need for the remote monitoring of patients, and now, remote monitoring has become the standard for decentralized clinical trials. This, complemented by the fact that clinical studies are becoming increasingly global, has created an urgent need for the translation and localization of clinical trial documentation. As patients move further away from study sites, there is an even more pressing need to develop culturally-sensitive, well-localized content for patient communication in order to build trust and drive patient engagement.

Learn more how CSOFT Health Sciences enables remote clinical trials for life science companies.

Multilingual Clinical Trials

Today, a growing number of clinical trials are conducted globally, with upward of 90 percent of new drugs approved in recent years undergoing trials and testing outside their primary markets. To meet this trend, multilingual clinical trial translation is vital.  From contract research organizations (CROs) and sponsors to institutional review boards (IRBs) and clinics, CSOFT’s 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 translation services.

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 to avoiding malpractice claims, and is a firm legal requirement of many government oversight agencies. CSOFT Health Sciences’ informed consent form (ICF) 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 (ICF) translations.

Trial Master File (TMF) Translations

Trial Master Files (TMF/eTMF) are a collection of essential documents used by regulatory authorities to determine compliance with Good Clinical Practices (GCP) and clinical trial protocol. TMFs and its digital format, eTMFs, are vital to gaining regulatory compliance when conducting clinical trials internationally. 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.

Learn more about our TMF/eTMF translations.

Patient Recruitment Translation

Patient recruitment is a crucial aspect of 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 the right 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.

Learn more about our patient recruitment materials translations.

End-Point Adjudication

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. 

Learn more about our end-point adjudication.

Our Methodology

CSOFT Health Sciences guarantees medical translation methodologies that are compliant with regulatory and legal standards, as required by our pharmaceutical clients. Our translators are native language subject matter experts with medical field knowledge translating specific content requirements. CSOFT assigns a team of senior medical translators, editors, and in-country reviewers to perform every translation project, with each individually responsible for translation, proofreading, editing, and independent review.

Our years of expertise and experience enable our team to customize operating processes on the basis of analysis for specific project requirements. Whenever necessary, extra quality control steps of back translation, linguistic validation, and in-country review (ICR) are performed.

Learn more about our quality assurance process.

Other Medical Translation Services

As well as translation and localization services coverage for other therapeutic areas, CSOFT’s end-to-end medical translation and localization services coverage extends across 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 in-country linguists and subject matter experts specialize in a wide range of localization solutions for medical content, including:

Quality Assurance

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.

Professional, high-quality localization of a health service or medical product is critical for medical translation solutions entering global markets. CSOFT understands the importance of accurate translation, which is why we have developed a process for quality assurance to ensure that any project that is translated meets quality standards in a timely manner that is also cost effective. Our advanced translation technology management system allows for translation projects to remain in one centralized location, updated in real time, to ensure that every step of the way, CSOFT has you covered. Additionally, we are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016, and our operations leverage best practices of ISO 27001 to ensure our customized solutions meet global regulatory requirements.

Learn more about our quality assurance process.

High Quality Academic Translations
ISO-certified Academic Translations

Data Security

As an ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 certified company, with operations leveraging best practices of ISO 27001, CSOFT’s translation process includes in-country reviewers, utilizing either new or established style guides, and subject matter expert (SME) linguists with a minimum of 7 years of experience. With over 20 years of industry experience, we have developed mature processes for translation, editing, proofreading (TEP), as well as project management.

Learn more about how CSOFT protects companies’ data.

GOT QUESTIONS?

Speak to one of our support agents.