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What Is a Serious Adverse Event (SAE)?

A Serious Adverse Event (SAE) is any untoward medical occurrence that results in outcomes such as death, life-threatening situations, hospitalization or its prolongation, persistent or significant disability, or a congenital anomaly or birth defect. This definition is standardized under ICH E2A guidelines and widely adopted by global health authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Common examples of SAEs include fatal cardiac arrest during a clinical trial, severe allergic reactions requiring emergency intervention, or birth defects linked to investigational products. These events require immediate attention due to their potential impact on patient safety and regulatory obligations.

SAE reporting plays a critical role in pharmacovigilance, enabling sponsors, CROs, and regulators to monitor drug safety across trial phases and in post-marketing surveillance. Timely and accurate SAE documentation supports early risk detection, protects trial participants, and helps sponsors maintain regulatory compliance across global markets.

For international trials, SAE report translation must be completed swiftly and with precision to meet expedited reporting timelines and satisfy local authority requirements. Sesen specializes in translating these critical documents with full regulatory alignment and linguistic accuracy to support global safety monitoring.

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Why Accurate SAE Translation Is Critical

Serious Adverse Event (SAE) reports are subject to strict global reporting timelines, with expedited submission requirements that include 7-day and 15-day windows depending on the severity and context of the event. Accurate translation of these reports is essential to ensure timely regulatory communication and to maintain compliance with authorities such as the FDA, EMA, MHRA, and PMDA.

Errors or delays in SAE report translation can compromise patient safety, disrupt ongoing clinical trials, and trigger regulatory penalties or site audits. Inaccurate translations may lead to misinterpretation of safety signals, delayed interventions, and noncompliance with Good Clinical Practice (GCP) and pharmacovigilance guidelines.

High-stakes safety data must be translated by professionals with medical subject matter expertise and working knowledge of pharmacovigilance terminology, including alignment with MedDRA coding standards. Clear, consistent translations also support effective risk mitigation strategies, enabling sponsors and CROs to make informed decisions and fulfill international regulatory obligations.

At Sesen, we provide fast, regulatory-compliant SAE report translation services to help clients meet global reporting standards and ensure critical safety data is communicated accurately across languages and jurisdictions.

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Sesen’s SAE Translation Capabilities

At Sesen, we deliver specialized SAE report translation services designed to meet the urgency, precision, and compliance demands of global pharmacovigilance programs.

We offer 24 to 72-hour turnaround times for urgent SAE filings to support accelerated reporting schedules. Our project workflows are optimized for rapid intake, triage, and delivery of high-priority safety documentation without compromising quality.

Our translations are performed by professional native linguists with clinical trial and regulatory expertise. Each linguist is trained in pharmacovigilance terminology, ensuring accurate interpretation of medical narratives, causality assessments, and safety conclusions.

Sesen ensures full alignment with global regulatory standards, including ICH E2B, MedDRA, FDA, EMA, and MHRA reporting requirements. Our teams apply standardized terminology and maintain strict adherence to format and language expectations mandated by health authorities.

We support SAE translations in over 150 languages, each localized for regional medical terminology and regulatory usage. This enables seamless cross-border safety communication for multinational trials and product safety surveillance.

All translation activities are governed by ISO-certified processes, including ISO 17100 for translation services, ISO 9001:2015 for quality management, and ISO 13485:2016 for medical device regulatory compliance. These certifications ensure a consistent, auditable, and high-quality output for every project.

Sesen’s robust infrastructure and domain-focused linguists make us a trusted partner for high-stakes SAE report translations required across diverse regulatory environments.

Supported SAE Report Formats

Sesen provides expert translation services for all major Serious Adverse Event (SAE) report formats, ensuring consistency, accuracy, and compliance across diverse regulatory jurisdictions.

We translate Council for International Organizations of Medical Sciences (CIOMS I) forms, widely used for reporting serious adverse drug reactions in international pharmacovigilance. Our linguists are experienced in the structured language and safety terminology required by global health authorities.

Sesen supports translation of E2B(R3) XML-based electronic reports used for automated safety data exchange with regulatory systems such as EudraVigilance, FAERS, and VigiBase. We provide both narrative and coded content translation while maintaining data structure integrity.

We translate country-specific SAE report templates, including:

  • FDA MedWatch Forms 3500 and 3500A
  • EMA’s EudraVigilance Individual Case Safety Reports (ICSRs)
  • PMDA-specific formats in Japan
  • Other regional pharmacovigilance reporting formats as required

Our familiarity with authority-specific formats helps sponsors and CROs meet localized compliance requirements across North America, Europe, and Asia.

Sesen handles both free-text SAE narratives and structured tabular formats, including causality assessments, timelines, and action outcomes. All content is translated with medical accuracy, preserving the original intent and clinical relevance.

By supporting the full spectrum of SAE report formats, Sesen ensures seamless integration with your safety workflows and submission systems across global markets.

Who We Support

Sesen provides specialized SAE report translation services tailored to the needs of life sciences organizations operating in highly regulated environments. Our clients rely on us to deliver fast, accurate translations that meet international compliance standards.

We support large and mid-sized pharmaceutical companies conducting global clinical trials and post-marketing surveillance. Our team ensures that serious adverse event data is translated accurately to meet multinational regulatory requirements and protect patient safety across jurisdictions.

Sesen partners with leading CROs to deliver scalable SAE translation services across multi-country studies. We integrate seamlessly into clinical workflows, helping CROs meet tight submission deadlines and maintain compliance with ICH GCP and sponsor-specific standards.

Our translations help internal safety teams manage case processing, signal detection, and expedited reporting. We support safety operations with high-quality translations of SAE narratives, MedDRA-coded terms, and causality assessments for global health authorities.

We assist regulatory teams in preparing submission-ready SAE documentation for FDA, EMA, MHRA, PMDA, and other regional authorities. Our linguists are trained in regulatory terminology and formatting expectations, helping clients reduce rework and accelerate approvals.

Sesen’s proven experience across the drug development lifecycle makes us a trusted partner for organizations that require precision, speed, and compliance in SAE report translation.

Quality Assurance Process

Sesen applies a rigorous quality assurance framework to ensure that every Serious Adverse Event (SAE) report translation meets the highest standards of linguistic precision, regulatory compliance, and data integrity.

All SAE translations undergo a two-step review process performed by native linguists with medical and pharmacovigilance backgrounds. This ensures accurate rendering of clinical terminology, causality assessments, and safety narratives in accordance with global regulatory expectations.

We enforce consistent use of terminology by aligning with MedDRA coding conventions, client-specific glossaries, and style guides. Our translators are trained to reflect precise risk descriptors and adverse event classifications, supporting clear and consistent safety communications across languages.

For critical filings or high-risk submissions, we offer back translation and reconciliation services to validate content accuracy and ensure alignment with the original source document. This is particularly useful for regulatory audits and high-stakes reporting to authorities such as the FDA, EMA, or PMDA.

Translations are delivered through secure, audit-enabled platforms, including our translation management system (TMS) or the client’s preferred portal. All activities are logged for traceability, supporting 21 CFR Part 11 and GxP compliance requirements for electronic records handling.

Sesen’s end-to-end quality process provides the assurance global life sciences clients need when translating time-sensitive, high-impact SAE reports.

Integration With Pharmacovigilance Workflows

Sesen’s SAE report translation services are designed to integrate seamlessly into your existing pharmacovigilance operations, helping streamline reporting workflows and accelerate time-to-submission across global markets.

We offer API-based connectivity and secure client portals that allow direct integration with safety databases and clinical document repositories. This enables efficient file exchange, automated job creation, and real-time status tracking while maintaining full data security and compliance.

Our workflows are fully compatible with widely used pharmacovigilance systems such as Oracle Argus Safety, ARISg, Veeva Vault Safety, and other adverse event management platforms. This ensures that translated content can be easily imported into structured fields or narrative sections without additional formatting.

Sesen provides comprehensive support across the full lifecycle of SAE documentation. From source language extraction and terminology standardization to submission-ready translated files, our team ensures that each step aligns with ICH E2B(R3), MedDRA coding, and region-specific formatting requirements.

Our integration-focused approach reduces administrative burden, improves translation turnaround times, and ensures that safety data moves efficiently from clinical operations to regulatory submission.

Related Services

Sesen offers a full suite of specialized translation services that support the broader needs of pharmacovigilance and clinical safety teams. These services are designed to complement SAE report translations and ensure consistency, compliance, and clarity across all safety documentation.

High-quality translation of non-serious adverse event reports to support comprehensive pharmacovigilance reporting. We ensure consistency between SAE and AE documentation for regulatory alignment.

Side-by-side comparison and resolution of discrepancies between original and back-translated content. Ideal for high-risk submissions and multilingual quality control across clinical and safety documents.

Precise translation and mapping of medical terms to MedDRA coding conventions. This service ensures accurate classification of adverse events and harmonized terminology across case narratives.

Translation of safety-related documentation in accordance with Good Clinical Practice (GCP) guidelines. We support sponsors and CROs in maintaining audit readiness and regulatory compliance in all trial regions.

Independent reverse translation of safety documents to verify linguistic and regulatory accuracy. Especially useful for validating critical content in informed consent forms, SAE narratives, and global safety communications.

Each of these services is fully integrated into our quality-controlled workflows, helping clients achieve consistency across global pharmacovigilance documentation and meet the expectations of regulatory authorities.

Frequently Asked Questions

Sesen offers expedited delivery options for SAE report translations, with turnaround times ranging from 24 to 72 hours depending on language pair, document length, and urgency. Our streamlined workflows and 24/7 project management allow us to support global clients operating under strict reporting timelines.

Yes. We provide weekend and after-hours coverage for high-priority SAE report translations. Our global linguist network and always-on project coordination enable us to meet 7-day or 15-day regulatory deadlines, even outside of standard business hours.

While Sesen does not assign or modify MedDRA codes, our linguists are trained to recognize and maintain MedDRA-aligned terminology during translation. We ensure consistency with existing coding frameworks and can collaborate with pharmacovigilance teams to align translations with your coding strategy.

We adhere to international guidelines including ICH E2B, GCP, and country-specific safety reporting standards such as FDA, EMA, MHRA, and PMDA. Our quality assurance process incorporates certified workflows (ISO 17100, ISO 9001, ISO 13485), terminology harmonization, and format-specific accuracy to meet regulatory expectations in each target market.

Ensure SAE Reports Are Translated Accurately and Delivered n Time

Timely and accurate translation of Serious Adverse Event (SAE) reports is essential for global pharmacovigilance compliance. Sesen combines medical domain expertise, multilingual precision, and ISO-certified workflows to support your safety reporting needs, on time and with full regulatory alignment.

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