IMPD Translations for Effective Multilingual Clinical Trials
The investigational medicinal product dossier (IMPD), also known as an IMP dossier, is a crucial document for clinical trial applications, making IMPD translations essential for access to the European clinical trial market. When testing a non-authorized investigational medicinal product (IMP), an IMPD is necessary to detail the quality of the IMP, as well as the pre-clinical, clinical, and risk and benefit analysis outlined in an Investigator’s Brochure (IB). Even for an authorized IMP, an IMPD may be necessary in addition to a Summary of Product Characteristics (SmPC) to approve the placebo used in a clinical trial for use. Accurate and efficient translation of both full and simplified investigational medicinal product dossiers (sIMPD) across languages is essential for regulatory compliance and access to European clinical trials. CSOFT Health Sciences’ global team of over 10,000 subject matter expert linguists is well-versed in navigating translation of these complex regulatory documents, all with quick turnaround times.
Clinical Trial Application (CTA) Translations
The clinical trial application is a crucial component of European clinical trials, making clinical trial application translations essential for regulatory compliance across languages. A clinical trial application (CTA), or CTA dossier, is submitted to European regulatory agencies to ensure that the investigational medicinal product (IMP) or other medical product being tested is approved for use in a clinical trial, and may include components such as a summary of product characteristics (SmPC), investigator’s brochure (IB), investigational medicinal product dossier (IMPD), and more. CSOFT Health Sciences’ global team of subject matter expert linguists have a minimum of 7 years in-country experience to ensure that your clinical trial application translations are accurate and follow regulatory guidelines. Perfecting our translation best practices with our cutting-edge cloud-based language technology as well as our linguistic validation process, ensures the highest quality medical translation for all your clinical trial needs.
Learn more about our clinical trial application translations.
Investigator’s Brochure (IB) Translations
Investigator’s brochure translations are an essential multilingual communications asset and are necessary for regulatory compliance. While trial sponsors are responsible for high volumes of documentation throughout all clinical trial phases, the investigator’s brochure (IB) is one of the most important documents and functions primarily to assess the benefits and risks of the investigational medicinal product (IMP) being studied. The IB also details information like the chemical, physical, pharmaceutical properties, and formulas of the IMP, as well as any side effects and the safety measures outlined in the study protocol. For both clinical and non-clinical studies, the investigator’s brochure must be presented to investigators, often in the languages of the country where the trial is being conducted. To help sponsors and other stakeholders throughout the clinical trials process, CSOFT Health Sciences offers IB translations with fast turnaround times for access to the European market.
Learn more about our investigator’s brochure translations.
Summary of Product Characteristics (SmPC) Translations
International regulations to gain marketing authorization for approved medicines outline specific language requirements which makes summary of product characteristics (SmPC) translations essential for companies looking to reach new markets. An SmPC is a legal document submitted to regulatory bodies within a dossier that provide information on the intended use of the medicine, method of administration, warnings and precautions, and therapeutic indications such as the disease or condition the medication is designed to target. Throughout the lifecycle of the medication, pharmaceutical companies can update the information included in the Summary of Product Characteristics as new data is collected through research. To help life science companies gain marketing authorization for new products, CSOFT Health Sciences leverages a global team of subject matter expert linguists with a minimum of 7 years’ experience to offer accurate and high-quality SmPC translations for access to the EU market.
Learn more about our SmPC translations.
End-to-End Clinical Trials Translations
As more and more clinical trials incorporate innovative technology and focus on patient-centric care, the need for multilingual trial documents is essential for communications and international regulatory compliance in Europe and beyond. Whether you are a pharmaceutical company, medical device manufacturer, or involved in other medical product clinical trials, bringing new products to market necessitates translations for a broad range of clinical trial documents, in addition to ensuring the highest degree of accuracy by using localization solutions like linguistic validation. To help trial stakeholders meet international regulations for clinical trials, CSOFT Heath Sciences offers a full range of medical translations in 250+ languages.
Learn more about our full coverage of clinical trial translations.
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.
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.
Learn more about our quality assurance process.
