Pharmacovigilance translations are crucial to ensure proper documentation and resolution of adverse drug reaction cases in global drug development. As the global pharmaceutical market shifts overseas, submitting highly accurate translations of standard pharmacovigilance documents like adverse event (AE) and individual case study reports (ICSR) to regulatory agencies on time is critical to protecting consumers worldwide. With an extensive network of subject-matter experts (SMEs) and a global network of 10,000+ in-country native linguists, CSOFT Health Sciences offers highly accurate and timely multilingual pharmacovigilance translation and localization solutions from DSURS and discharge reports to CIOMs forms and clinical trial documents.
Adverse Event (AE) Reporting Translations
AE reporting translations are essential in medical localization to resolve the under-reporting of AEs to the post-marketing databases. Reporting all cases of adverse events is crucial, whether mild and expected or severe and unexpected. Mistranslation of AE reporting may lead to non-compliance with regulatory requirements and can put patients at risk from a safety standpoint. To ensure safety and mitigate risks, CSOFT Health Sciences provides high-quality translations for the documents and materials essential for recording, diagnosing, and treating cases of adverse events.
Learn more about our AE reporting translations.
Multilingual Clinical Trial Translations
After drugs have been approved for market, some sponsors will hold Phase IV clinical trials to conduct additional pharmacovigilance on the drug’s safety. Effectively translated and localized patient recruitment material and other multilingual clinical trial documentation are vital for achieving effective pharmacovigilance. CSOFT Health Sciences helps organizations enhance pharmacovigilance by providing high-quality clinical trial documentation and remote clinical trial translations.
With our global network of in-country linguists and subject matter experts, we specialize in a wide range of clinical trial document translations, including:
Learn more about our complete coverage of clinical trial translations.
End-Point Adjudication Translation Services
In endpoint adjudication, a blind committee of experts – known as Clinical Event Committees (CEC) or End-point Adjudication Committees – independently evaluates clinical events from a clinical trial and adjudicates them with predetermined event classification criteria. This adjudication assessment process reduces potential bias and increases the validity of trial outcomes. As more and more clinical trials are conducted in countries where English is not the primary language, the need for highly accurate translations of both clinical endpoint adjudication and source case documents with fast turnaround times is vital for successful clinical trials.
Learn more about our endpoint adjudication translations.
Development Safety Update Report Translations (DSUR)
With the worldwide expansion of drugs undergoing global clinical trials, development safety update report translations (DSUR) are required to address the safety information of drugs. Inaccurate translations can have consequences that may compromise the safe use of drugs. Whether you are a patient, clinical research organization, health organization, or pharmaceutical company, development safety update reports are ensured to comply with global regulatory standards. With an extensive network of professional in-country linguists and subject matter experts, we have the resources and experience to help successfully translate development safety update reports.
Learn more about our development safety update report translations.
Good Manufacturing Practice (GMP) Translations
Good manufacturing practice (GMP) is essential for the quality production of pharmaceutical products and medical devices, making GMP translations necessary for meeting global manufacturing standards. GMP regulates medical products during production to protect patients from ineffective treatment and adverse events caused by contamination, incorrect labeling, and other manufacturing quality issues. Whether compliant with global practices or certified in a specific market’s standards, like the FDA’s current good manufacturing practice (cGMP), GMP translations ensure that all manufacturing quality control measures, from audits and certification visits to everyday production, meet regulatory requirements in any country. CSOFT Health Sciences translates a wide range of GMP documents, including site master files, validation master plans, and CAPA SOPs, to ensure your GMP translations are understandable throughout the manufacturing process.
Learn more about our GMP translations.
Translating Patient Safety Narratives for Global Pharmacovigilance
Patient safety narratives form a cornerstone of clinical reporting, capturing vital safety data for drugs under trial. Our service ensures these narratives are precisely translated, adhering to ICH E3 guidelines across all clinical phases. These translations encompass narratives for SAEs, AESIs, and other significant events and are crucial when studies span multilingual participants or when regulations demand multilingual reporting. Quality translations uphold the integrity of safety data, which is essential for global regulatory submissions and patient safety.
Learn more about our patient safety narrative 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.
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.