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.

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.

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.