Adverse Event Reporting Translations

High-quality adverse event reporting translations with fast turnaround times to meet time sensitive regulatory deadlines.

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To avoid the issue of under-reporting of adverse events and meet the 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 7 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, be 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 global network of linguists and a team of subject matter experts when it comes to 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

End-to-End Pharmacovigilance Translations

In the field of 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 clinical trials being conducted globally, ensuring report forms, IRB documents, and patients records align with regulatory guidelines and language requirements is a top priory 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:

Learn more about our pharmacovigilance document translations.

Quality Assurance

Through our innovative cloud-based technology, CSOFT offers an online translation management ecosystem for one central location to leverage both translation memory as well as terminology management in real time.

Professional, high-quality localization of a health service or medical product is critical for medical translation solutions entering global markets. CSOFT understands the importance of accurate translation, which is why we have developed a process for quality assurance to ensure that any project that is translated meets quality standards in a timely manner that is also cost effective. Our advanced translation technology management system allows for translation projects to remain in one centralized location, updated in real time, to ensure that every step of the way, CSOFT has you covered. Additionally, we are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016, and our operations leverage best practices of ISO 27001 to ensure our customized solutions meet global regulatory requirements.

Learn more about our quality assurance process.

High Quality Academic Translations
ISO-certified Academic Translations

Data Security

As an ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 certified company, with operations leveraging best practices of ISO 27001, CSOFT’s translation process includes in-country reviewers, utilizing either new or established style guides, and subject matter expert (SME) linguists with a minimum of 7 years of experience. With over 20 years of industry experience, we have developed mature processes for translation, editing, proofreading (TEP), as well as project management.

Learn more about how CSOFT protects companies’ data.

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