With more than 50% of all clinical trials being conducted overseas, investigator’s brochure (IB) translations are an essential multilingual communications asset for regulatory compliance. Within the high volumes of documentation sponsors must submit throughout each trial phase, IBs are among the most important functions primarily to assess the benefits and risks of the investigational product (IP) being studied. IBs also contain detailed information such as chemical formulas, 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, IBs must be presented to investigators in the primary languages of the country where the trial is being conducted.
To help sponsors and other stakeholders navigate the oftentimes complex 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 Translation Services
As an increasing number of clinical trials begin to incorporate innovative technology and focus into their patient-centric care, the need for multilingual trial documents is essential for communications and international regulatory compliance. Whether a pharmaceutical company or medical device manufacturer, bringing new products to market requires 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 translation services for a full range of clinical trial documents, including:
Drug Development Process Documentation Translation Solutions
With a growing number of medications and treatments being developed throughout the pharmaceutical industry, translations of drug development process documentation are necessary to adhere to the regulatory standards that regulate 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 CSOFT’s drug development process documentation translation solutions.
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 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 translation services.
Adverse Event Reporting Translation Services
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 translation services.
Investigational Medicinal Product Dossier (IMPD) Translation Services
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 IMP’s quality and 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 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 translation services.
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.
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.