Global Pharmacovigilance Translation
Stepes (/’steps/) provides comprehensive pharmacovigilance (PV) translation services for all areas of drug safety and compliance, covering both clinical and marketed products. Our industry expertise, paired with technology-driven localization solutions, ensures accurate and scalable PV translations in over 100 languages.
Accurate PV Translations You Can Trust
Do you need professional pharmacovigilance translation services to ensure international drug safety and global regulatory compliance? Look no further than Stepes. We offer expert translations for all areas of the drug safety landscape, from ICSR and PV signal translation to REMS and medical affairs localization. Our dedicated team of life sciences translators and multilingual drug safety subject matter experts utilize Stepes’ advanced language automation technologies, ensuring precision and efficiency. Global clinical research organizations (CROs) and pharmaceutical sponsors rely on us for exceptional PV translations in European, Asian, and Latin American languages.
Precision in pharmacovigilance translation is non-negotiable; inaccuracies not only jeopardize patient safety but also pose significant legal risks for pharmaceutical entities. Beyond the expertise of our linguistic specialists, who are well-versed in the intricacies of the pharmacovigilance sector, Stepes incorporates cutting-edge AI and machine learning into the PV translation workflow. These tools streamline the review of source documents, pinpoint ambiguities, discrepancies, and potential errors, enable context-driven terminology extraction, and automate rigorous quality assurance protocols. Our unique combination of human expertise and technological innovation allows Stepes to consistently deliver high-quality, large-scale translations tailored to the pharmacovigilance industry.
Types of Pharmacovigilance Content We Translate
Stepes provides professional PV translation services to meet our clients’ pharmacovigilance documentation and reporting requirements across various languages and cultures. Our linguistic experts have a deep understanding of both the language and the pharmacovigilance domain, ensuring accuracy and consistency in the following areas:
- Individual Case Safety Reports (ICSRs)
- Risk Management Plans (RMPs)
- Periodic Safety Update Reports (PSURs)
- REMS (Risk Evaluation and Mitigation Strategies)
- PV Signal Documentation
- Medical Affairs Localization
- Patient Information Leaflets (PIL) and Labels
- Informed Consent Forms
- Pharmacovigilance Training Materials
- Communication with Regulatory Authorities
- Pharmacovigilance System Master Files (PSMF)
- Safety Announcements and Withdrawal Notices
Individual Case Safety Reports (ICSRs) Translation
Stepes’ pharmacovigilance translation services include accurate ICSR localization. ICSRs are detailed reports of individual patient cases that outline adverse reactions or events. When these reports come from non-English speaking regions, or need to be submitted to regulatory authorities in other languages, their accurate translation becomes essential. Our ICSR translation process involves a two-stage verification: initial translations are conducted by life sciences experts, followed by a review from a second linguist with pharmacovigilance expertise. It’s imperative that the translated content is formatted and structured correctly to ensure seamless integration and submission to regulatory platforms, maintaining data integrity and compliance.
Risk Management Plans (RMPs) Translation
Stepes provides PV translations for RMP documents, outlining the risk management system a company aims to implement for specific medicinal products prior to submission to local health authorities. We handle all RMP materials, including Safety Specifications, Pharmacovigilance Plan, Risk Minimization Measures, and Plans for Post-Authorization Safety Studies (PASS). Given the critical nature of these documents, accurate translation is essential to ensure that all risks and plans are clearly communicated and understood by local health authorities and the public across diverse regions.
REMS Documentation Translation
Do you need to translate Risk Evaluation and Mitigation Strategies (REMS) documentation into Spanish, Chinese, or other languages? Stepes has extensive expertise in REMS translations, assisting our clients in navigating the challenges posed by linguistic barriers when managing drug-related risks. We recognize the crucial role of REMS in conveying essential safety information and ensuring adherence to required measures aimed at mitigating drug-associated risks. Our professional translators, proficient in the specialized language of pharmacovigilance, are skilled at capturing the intricate nuances of REMS content.
Pharmacovigilance Training Localization
Pharmacovigilance training courses are an essential tool to educate healthcare professionals, internal teams, and patients about drug safety. These courses delve into aspects like complaints handling, adverse effects/adverse events reporting, and other pharmacovigilance regulations. Stepes provides professional PV training course translation and localization services, translating both text content and video assets with voice-over and subtitles. Our localization process ensures that all materials, whether static text or multimedia, are technically and linguistically tailored for each target audience. To learn more about Stepes’ comprehensive elearning translation solutions, please click here.
PV Signal Translation
Stepes possesses specialized linguistic expertise and adheres to industry-standard localization practices for translating pharmacovigilance signal documentation. These documents contain crucial data elements such as adverse event descriptions, causal relationships, severity gradings, and outcomes, each of which pertains to newly identified or altered adverse effects associated with medicinal products. The robust detection, comprehensive assessment, and clear understanding of these signals often necessitate translation to facilitate seamless communication among global teams and to ensure accurate representation to international regulatory bodies. Leveraging our deep domain knowledge and technology-driven quality assurance protocols, Stepes delivers best-in-class PV signal translations for this critical area of pharmacovigilance.