Clinical trial agreement translations are essential for sponsors to ensure regulatory compliance at clinical study sites around the world and across languages. Clinical trial agreements (CTAs), also called clinical study agreements (CSAs), are legally binding contracts used to define sponsor, site, and researcher responsibilities before a clinical trial commences and must account for project goals, financial agreements, patient safety and monitoring, publication and intellectual property (IP) terms, and more. As industry sponsors increasingly include diverse and multilingual study sites in their clinical trials, medical translations of these highly regulated documents can help sponsors prioritize patient-centricity and meet clinical trial endpoints efficiently.
CSOFT Health Sciences offers clinical trial agreement translation support in over 250+ languages for pharmaceutical and medical device companies, CROs, and local study site leaders.
Experts in Health Science Law
As clinical trials cross borders and the health science industry becomes increasingly global, timely translation of legal documents, including clinical trial agreements, is vital to ensure legal compliance and reduce the risk of litigation. CSOFT Health Sciences provides health science companies with efficient and accurate legal translation services for a range of documents, such as memorandums of understanding (MoU), litigation support documents, trademark applications, and international business agreements. With our team of health science law subject-matter experts and a global network of over 10,000 in-country native linguists, your health science legal documents are in good hands.
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Patient-Centric Clinical Study Translations
Ensuring that clinical trial agreements and associated study materials align with international regulations is pivotal in the expansive landscape of global clinical trials. Therefore, clinical study translations are increasingly important to ensure that pharmaceutical, medical device and medical product clinical trials follow country-specific regulatory guidelines across languages. From patient-facing materials like patient diaries translations and patient-reported outcome (PRO) translations to remote monitoring translations all the way through trial close-out translations, sponsors who engage patients through localized content meet endpoints and roll out new medical products faster.
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Medical Document Translations
Clinical trial agreement translations are just one of the many medical document translation services that ensure sponsors are following regulatory guidelines when conducting clinical trials internationally. Accurate medical document translations are crucial for every step of the clinical trial process and beyond, including:
- Clinical trial protocol translations
- Investigator’s brochure (IB) translations
- Informed consent form translations
- Patient information sheet translations
- Case report form (CRF) translations
- CTD and eCTD translations
- Clinical outcomes assessment (COA) translations
- Pharmacovigilance translations
CSOFT Health Sciences has the linguistic and regulatory expertise to provide accurate and timely communication solutions to engage multilingual study participants and ensure quality medical care beyond clinical trials.
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ICF Translations
Accurate translation of informed consent forms is crucial within the context of clinical trial agreements to ensure both patient safety and uphold the legal integrity of healthcare entities involved in the trials. In the realm of global clinical trials, any oversight in translating these forms can lead to patients making uninformed decisions, presenting a significant legal hazard that can culminate in malpractice suits. It’s essential, especially for patients unfamiliar with English, to receive impeccably translated consent forms aligning with the specificities of clinical trial agreements. This ensures a thorough understanding of the trial’s regulatory mandates. Moreover, precise translations serve as a robust communication tool, enabling patients to have transparent discussions with their healthcare providers about the trial, its procedures, potential risks, and outcomes, thereby strengthening mutual comprehension and trust.
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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 at least seven years of experience and work with in-country reviewers and project style guides to meet industry standards. CSOFT offers an online translation management ecosystem for one central location to leverage real-time translation memory and terminology management through our innovative cloud-based technology. Every step of the way, CSOFT has you covered.
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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 the best practices of ISO 27001. They are designed to protect everything from source data to translations. From our 24/7/365 data monitoring and advanced encryption to our access control measures, you can be sure that your project data is safe from start to finish.
Learn more about how CSOFT prioritizes data security.