Pharmacovigilance (also known as PhV, PV, and drug safety) is a branch of pharmacology that focuses on monitoring, analyzing, reporting, and preventing adverse drug reactions (ADRs). As the global pharmaceutical market shifts overseas, submitting extremely accurate translations of common pharmacovigilance documents like adverse event (AE) and individual case study reports (ICSR) to regulatory agencies on time is critical to protecting consumers worldwide. With a large network of subject-matter experts (SMEs) and a global network of 10,000 in-country native linguists, CSOFT offers highly-accurate and timely multilingual pharmacovigilance translation and localization solutions in 250+ languages, from DSURS and discharge reports to CIOMs forms and clinical trial documents.
Adverse Event (AE) Reporting
Pharmacovigilance requires documenting and reporting a wide range of adverse drug reactions (ADRs) such as adverse reactions (ARs), serious adverse reactions (SAR), serious adverse events (SAE), and suspected unexpected serious adverse reaction (SUSAR) to investigators and regulatory bodies. Because adverse event reports must be conducted thoroughly and submitted quickly to identify what caused adverse drug reactions in as little time as possible, providing timely and highly-accurate translations of adverse event reports are essential. With a team of 10,000 in country linguists and subject-matter experts, CSOFT provides highly accurate translations of pharmacovigilance documentation such as DSURs, SUSARS, SAEs, Ars, AEs to enable effective pharmacovigilance monitoring and reporting.
Learn more about our medical document 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. However, as more clinical trial studies are being conducted overseas, having effectively translated and localized patient recruitment material and other multilingual clinical trial documentation is vital for conducting effective pharmacovigilance. CSOFT helps organizations enhance pharmacovigilance by providing high-quality clinical trial documentation and patient recruitment translations in 250+ languages.
Learn more about our clinical trial translation services.
End-Point Adjudication Translation Services
In endpoint adjudication, a blind committee of experts – known as Clinical Event Committees (CEC) or Endpoint Adjudication Committees – independently evaluate 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 are vital for successful clinical trials.
Learn more about our endpoint adjudication translations.
We have well-documented and fully traceable information security policies, checklists, and quality records. CSOFT understands the importance of security to our clients and we take nothing for granted when confidentiality is a concern. All our data and security processes comply with our certified ISO standards 13485:2016 and ISO 9001:2015. We are also compliant with ISO 17100 and leverage best practices from ISO 27001.
Learn more about our data security.
High-quality translation and localization is extremely important in pharmacovigilance – inaccuracy along the way can not only result in wasted time, money, and effort, but also affect patients’ lives. That is why CSOFT is dedicated to ensuring the highest-quality pharmacovigilance translations. To do so, we use in-country linguists with a minimum of 7 years of experience, combined with our extensive network of subject matter experts. In addition, we have perfected our pharmacovigilance localization best practices through linguistic validation, back translation, and terminology management, we have the tools and team to help you meet the submission demands of regulatory bodies such as the FDA, EMA, and NMPA.
Read more about our quality assurance.