With more than 50% of all clinical trials conducted overseas, investigator’s brochure translations are an essential multilingual communications asset for regulatory compliance. Among the high volumes of documentation sponsors must submit throughout each trial phase, the investigator’s brochure (IB) is among the most important. It functions primarily to assess the benefits and risks of the investigational product (IP) being studied. The IB also details information like the chemical, physical, pharmaceutical properties, and formulas of the IP, as well as any side effects and the safety measures outlined in the study protocol. Thus, for both clinical and non-clinical studies, the investigator’s brochure must be presented to investigators in the languages required in the country where the trial is being conducted.
To help sponsors and other stakeholders throughout the clinical trials process, CSOFT Health Sciences offers investigator’s brochure translations with fast turnaround times in 250+ languages. With our global network of 10,000+ in-country linguists and subject matter experts, we can deliver your medical communications when and where you need medical translation services.
End-to-End Clinical Trial 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. Whether you are a pharmaceutical company or medical device manufacturer, bringing new products to market necessitates translations for a broad range of clinical trial documents and ensures the highest degree of accuracy by using localization solutions like linguistic validation. To help trial stakeholders meet international regulations for clinical trials, CSOFT Health Sciences offers a full range of clinical trial translations, including:
Learn more about our full range of clinical trial translations.
Drug Development Process Documentation Translations
With a growing number of drugs being developed in the pharmaceutical industry, drug development process documentation translations are necessary to adhere to regulatory standards to access markets across the globe. Whether for a pharmaceutical company, clinical research organization, the U.S. Food and Drug Administration (FDA), or the European Union (EU), process documentation ensures that drugs going through all development cycle phases meet necessary regulations to ensure safety and efficacy.
Learn more about our drug development process documentation translations.
Essential Translation of Informed Consent Forms
Accurate translations of informed consent forms are critical to maintaining patient safety and upholding the legal responsibilities of healthcare providers and life science companies. Precise language ensures that patients fully understand the details of the treatment they may be asked to consent to, including any potential risks and side effects. This clarity is vital for non-English speaking patients, protecting against miscommunication and potential legal issues and supporting informed patient decisions in clinical trials.
Learn more about our ICF translations.
Adverse Event Reporting Translations
To avoid under-reporting adverse events and meet time-sensitive deadlines for clinical reporting in clinical trials, adverse event reporting translations are essential for regulatory compliance and successfully bringing new products to market. During clinical trials, adverse events (AE), serious adverse events (SAE), and adverse drug reactions (ADRs) are expected to be reported to the regulating agency within specific timelines, which can be as short as seven days as outlined under FDA regulations for Investigational New Devices (INDs). With an increasing number of clinical trials being conducted internationally, providing multilingual adverse event reports and documents is required by many global regulators and is essential for avoiding potentially life-threatening situations.
Learn more about our adverse event reporting translations.
Investigational Medicinal Product Dossier (IMPD) Translations
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 must detail the IMP’s quality and the pre-clinical, clinical, 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.
Learn more about our IMPD translations.
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.