Adverse event reporting translations are essential for regulatory compliance and successfully bringing new products to market to avoid under-reporting adverse events and meet the time-sensitive deadlines for clinical reporting in clinical trials. 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). Within the field of pharmacovigilance, clinical monitoring for all SAEs, ADRS, and AEs is an integral process for ensuring the safety of trial subjects and proving the efficacy of new medical devices and pharmaceutical products. With an increasing number of clinical trials being conducted internationally, being able to provide multilingual adverse event reports and documents is required by many global regulators and is essential for avoiding potentially life-threatening situations. With a worldwide network of linguists and a team of subject matter experts in pharmacovigilance processes, CSOFT Health Sciences offers fast turnaround times to meet your adverse event reporting translation needs across 250+ languages. We provide translations for all types of adverse event reporting, including:
- Adverse Drug Reaction (ADR) Translations
- Suspected Unexpected Serious Adverse Reaction (SUSAR) Translations
- Serious Adverse Event (SAE) Translations
- Serious Adverse Reactions (SARs) Translations
- Annual Safety Report (ASR) Translations
- Periodic Safety Update Report (PSUR) Translations
- Development Update Safety Report (DUSR) 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 you are a pharmaceutical company or clinical research organization from the U.S. or European Union (EU) regulatory bodies, process documentation ensures that drugs go through all development cycle phases while meeting regulations to ensure safety and efficacy. With a global team of 10,000+ in-country linguists and subject matter experts, CSOFT Health Sciences provides high-quality customized translation and localization solutions for a full range of content, documents, and materials for research organizations and companies in the drug development field.
Learn more about our drug development process documentation translations.
End-to-End Pharmacovigilance Translations
In drug safety reporting, high volumes of documents and translations are required to accurately monitor, analyze, report, and prevent adverse events (AE) and unintended reactions to pharmaceutical products. Comprehensive safety reporting is essential for all types of new medication, but in the growing space of clinical trials being conducted globally, ensuring report forms, IRB documents, and patient records align with regulatory guidelines and language requirements is a top priority for trial CROs and trial sponsors. To help provide extensive language coverage for documents crucial to pharmacovigilance, CSOFT Health Sciences offers accurate translations with expedited turnaround times for all phases of drug safety reporting, including:
- IND Safety Report Translations
- Medical Record (EHR) Translations
- Computerized Patient Record System (CPRS) Translations
- Investigator’s Brochure (IB) Translations
- Case Report Form (CRF) Translations
- IRB Correspondence Documentation Translations
Learn more about our pharmacovigilance document translations.
Trial Close-out Report Translations
As clinical trials expand worldwide, trial close-out monitoring report translations become essential in ensuring trial activities are accurately reported after the study. To access foreign markets, documents such as study close-out reports and clinical trial agreements must be translated accurately to meet regulatory requirements for future clinical trial inspections.
In addition to our trial close-out report translation services, we provide translations for a full range of content, documents, and materials for medical professionals and researchers in global clinical studies.
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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.
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.