Adverse Event Translation Services
Language Scientific is the only translation company with deep healthcare, regulatory and language understanding that enables customized, reliable and on-time completion of each adverse event translation.
Adverse Event Translation Metrics
Accurate Adverse Event Translations
Adverse event translations are critical to regulatory compliance—and to protecting patient safety. During clinical trials, timely and accurate reporting of adverse events (AEs), serious adverse events (SAEs), and adverse drug reactions (ADRs) is required by global health authorities. In some cases, such as under FDA regulations for investigational new drugs (INDs), reports must be submitted within as little as seven days.
Language Scientific supports life science companies with fast, compliant translations for adverse event documentation. With the rise of international clinical trials, multilingual safety reporting is no longer optional—it’s essential for avoiding under-reporting, meeting submission deadlines, and ensuring trial integrity.
We combine a global network of native-speaking linguists with subject matter experts in pharmacovigilance and regulatory affairs to deliver accurate translations in over 250 languages—on time and ready for submission.
Trusted By Leading Companies
Adverse Event Translation Solutions
No two clinical trials are the same—and neither are your translation needs. At Language Scientific, we deliver customized solutions that align with your timelines, document formats, review cycles, and regulatory obligations. Whether you’re managing a single-site trial or a global multi-phase study, we adapt to your process—not the other way around.
Our customized services include:
- Dedicated project managers who understand your trial and coordinate every step
- Integration with your clinical platforms (eTMF, CTMS, or safety databases)
- Flexible delivery formats and customized templates for CIOMS, MedWatch, and other standard forms
- Rush turnaround options to meet urgent submission deadlines
- Reconciliation support for multi-source safety data
- Client-specific translation memories and style guides to ensure consistency across all documents
From first-patient-in to final report, we provide scalable, reliable support that keeps your adverse event reporting on time and in compliance—every step of the way.
Adverse Event Documentation Translation
Serious Adverse Event (SAE) Reports
Adverse Drug Reaction (ADR) Summaries
Clinical
Narratives
Patient Interviews and Questionnaires
Pharmacovigilance Case Files and Safety Updates
Adverse Event Translation Benefits
- Regulatory Compliance:
Translations adhere to strict global pharmacovigilance requirements, including FDA, EMA, and ICH guidelines. Accurate translations help companies avoid regulatory penalties.
- Clinical Trial Efficiency:
Our AI-optimized process and expert linguists enable rapid turnaround times, allowing companies to submit reports on time and avoid bottlenecks in regulatory reviews.
- Risk Mitigation:
Accurate translations reduce the risk of misinterpretations that could compromise patient safety, delay approvals, or lead to costly legal and regulatory consequences.
