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Smarter Translation Workflows with Agentic AI

Sesen leverages agentic AI to automate, coordinate, and continuously improve clinical trial translations. Unlike traditional AI or machine translation alone, agentic AI enables autonomous, multi-step decision-making to reduce turnaround times, improve quality, and support real-time updates across multilingual studies.

What Is Agentic AI?

Agentic AI refers to advanced artificial intelligence systems that can autonomously plan, execute, and refine complex tasks through multi-step reasoning. Unlike traditional AI models that respond to isolated prompts or follow static rules, agentic AI operates with goal-oriented logic, adapts to changing inputs, and self-directs its actions based on outcomes and contextual feedback.

In clinical trial translation, this capability is transformative. Agentic AI can orchestrate multiple translation processes simultaneously, such as machine translation, terminology alignment, regulatory compliance checks, and human review triggers, without requiring constant manual intervention. This makes it ideally suited for high-volume, dynamic, and multilingual workflows across global studies.

Whereas standard AI systems operate at the sentence or task level, agentic AI works across the full workflow. It identifies when to translate, how to validate quality, and when to escalate to a human linguist based on preconfigured thresholds or detected risks. This autonomy accelerates timelines while maintaining consistency and regulatory precision.

At Sesen, agentic AI complements SesenGPT by managing end-to-end coordination. While SesenGPT provides accurate, domain-trained linguistic output, agentic AI ensures those outputs are applied intelligently and efficiently within a structured clinical translation pipeline.

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Why Agentic AI for Clinical Trial Translations

Clinical trials generate a continuous stream of documentation that must be translated quickly, accurately, and in compliance with regulatory standards across multiple regions. Traditional translation methods often fall short when managing the scale, speed, and complexity required in today’s global studies.

Agentic AI addresses these challenges with intelligent automation that adapts to change, reduces delays, and ensures linguistic and regulatory alignment throughout the trial lifecycle.

Key Drivers for Agentic AI in Clinical Trial Translation

From protocols and investigator brochures to patient-facing materials, trials require consistent, high-quality translations across 10 or more languages per study. Agentic AI scales efficiently to meet this demand.

Mid-study updates are common and must be reflected accurately across all translated materials. Agentic AI detects changes, automates retranslation, and coordinates distribution across global sites.

Compliance with local authorities such as FDA, EMA, and PMDA demands precise terminology and formatting. Agentic AI applies country-specific language rules and terminologies with consistency.

Static workflows delay study start and regulatory approval. Agentic AI accelerates timelines by executing translation, quality review, and validation steps in parallel, based on real-time decision-making.

Manual translation and review processes scale linearly with each new language or amendment. Agentic AI reduces overhead by automating repetitive tasks and minimizing unnecessary human involvement.

Clinical trials don’t wait. Neither should your translations.

Agentic AI Use Cases Across the Clinical Lifecycle

Agentic AI supports the full clinical trial lifecycle with scalable, autonomous translation workflows. From protocol authoring to post-approval updates, Sesen’s agentic platform streamlines complex multilingual tasks with precision and speed.

Agentic AI automates the translation and revision of clinical protocols, investigator brochures, and regulatory submissions in alignment with global standards including FDA, EMA, PMDA, and MFDS. It applies approved terminology databases and translation memories to ensure consistency across all document types.

Agents detect when updates occur, apply validated language assets, and trigger human review only when thresholds for ambiguity or compliance risk are exceeded. This reduces turnaround time and enhances traceability for audit readiness.

Informed consent forms (ICFs), patient diaries, medication guides, and safety instructions must be both accurate and easy to understand. Agentic AI handles these translations with clarity-first logic, rewriting phrasing for health literacy while adhering to approved medical terminology.

QA agents optimize reading level, flag potential misinterpretations, and localize tone and structure for target populations—ensuring patients can engage confidently in their native language.

Agentic AI enables faster, localized rollout of study recruitment materials across global channels. Whether it is digital ads, landing pages, social media campaigns, or SMS outreach, the system adapts core messages to match regional cultural nuances and regulatory guidelines.

Real-time linguistic agents support prescreening by translating patient queries and eligibility criteria dynamically, reducing delay in patient onboarding.

Trials frequently undergo mid-study updates. Agentic AI tracks changes across protocols, investigator letters, and patient communication, then initiates translation updates automatically. Updated content is pushed to all affected language versions and study sites with minimal manual input.

This reduces the risk of outdated or inconsistent documentation and accelerates global amendment rollout.

Agentic AI coordinates interface localization for electronic clinical outcome assessments (eCOA), ePRO systems, and other clinical software tools. It identifies translatable strings, applies language rules, and manages LQA workflows for functional and linguistic validation.

Agents sync with agile development cycles and version control systems to ensure translation stays current with feature updates and device-specific rendering.

Agentic AI Workflow at Sesen

Sesen’s agentic AI platform orchestrates each stage of the clinical trial translation process using structured, intelligent automation. From file intake to audit-ready output, the system delivers quality, speed, and compliance at scale.

We leverage advanced translation memory (TM) tools and client-specific termbases to maintain linguistic consistency across documents, reduce turnaround times, and lower costs—especially for large or rolling submissions.

Our QA workflows include automated linguistic checks, formatting validation, and regulatory terminology alignment, followed by full human review by qualified medical and regulatory linguists to meet submission-grade standards.

Sesen supports seamless integration with leading document and submission platforms such as Veeva Vault, MasterControl, and Lorenz DocuBridge, enabling streamlined handoffs, version control, and regulatory formatting compliance.

Our cloud-based translation environment is built for multilingual project orchestration, supporting simultaneous submissions to multiple authorities, real-time collaboration, and rapid updates in response to agency feedback.

Our cloud-based translation environment is built for multilingual project orchestration, supporting simultaneous submissions to multiple authorities, real-time collaboration, and rapid updates in response to agency feedback.

Our cloud-based translation environment is built for multilingual project orchestration, supporting simultaneous submissions to multiple authorities, real-time collaboration, and rapid updates in response to agency feedback.

Our cloud-based translation environment is built for multilingual project orchestration, supporting simultaneous submissions to multiple authorities, real-time collaboration, and rapid updates in response to agency feedback.

Key Benefits for Sponsors and CROs

Sesen’s agentic AI platform delivers measurable performance gains across global clinical trial translation workflows. By automating coordination, quality checks, and version control, the system reduces timelines, increases scalability, and enhances compliance—without compromising accuracy or oversight.

Agentic AI accelerates translation workflows by executing tasks in parallel and removing unnecessary delays. From protocol translations to patient-facing content, documents are processed and delivered significantly faster than traditional models.

Unlike manual workflows that scale linearly with each language, agentic AI adapts to high-volume, multi-language demands with minimal overhead. It supports global trial expansion without driving up cost or complexity.

The system intelligently assesses translation quality and only triggers human review when thresholds are not met. This optimizes linguist time and reduces project cost while maintaining high standards.

Agentic AI integrates regulatory terminology databases and style guides for region-specific accuracy. It detects inconsistencies and aligns translations with the requirements of authorities such as the FDA, EMA, and PMDA.

Each decision, revision, and version is logged for full traceability. Sesen’s platform supports secure workflows that meet requirements for HIPAA, GDPR, and GxP environments.

The solution integrates with existing translation memories (TM), translation management systems (TMS), and decentralized clinical trial (DCT) platforms. This ensures continuity and maximizes reuse of previously approved content.

Human Oversight and Quality Control

At Sesen, agentic AI is designed to enhance, not replace, the critical role of expert human linguists. While the system automates repetitive and rules-based tasks, final language accuracy, nuance, and regulatory confidence are supported through structured human intervention.

Agentic AI operates within strict quality governance frameworks, including ISO 17100, HIPAA, and GxP-aligned processes. Each translation task is continuously assessed against project-specific criteria. If the system detects content that falls outside defined quality thresholds, such as ambiguous clinical phrasing or unaligned terminology, it flags the segment for human review and resolution.

Clients benefit from tailored control settings that define when and how human experts are engaged. Whether for high-risk documents, specific language pairs, or sensitive trial phases, these thresholds ensure human involvement is applied precisely where it delivers the most value.

All agent actions, decisions, and revisions are transparently logged, generating a complete audit trail for each deliverable. This level of traceability supports sponsor compliance, CRO oversight, and regulatory inspection readiness across every stage of the study.

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Built to Work with SesenGPT

Sesen’s agentic AI platform is fully integrated with SesenGPT to create a hybrid, intelligent translation infrastructure optimized for clinical research. While SesenGPT generates high-quality, domain-specific translations and edits using advanced large language models, agentic AI manages the broader orchestration of the translation workflow.

Agentic AI triages incoming content, assigns the appropriate translation method based on document type and quality thresholds, and monitors output for accuracy, regulatory alignment, and consistency. It routes flagged content to SesenGPT for adaptive rewriting, post-editing, or contextual enhancement as needed.

This division of labor enables greater speed and precision across multilingual studies. Agentic AI provides structured, rule-based oversight, while SesenGPT delivers linguistic fluency and subject matter depth across therapeutic areas.

Together, they form a scalable, adaptive system that delivers both quality and efficiency for global trial documentation, patient communications, regulatory submissions, and software interface localization.

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Compliance and Data Security

Sesen’s agentic AI platform is built to meet the highest standards of data security and regulatory compliance required in global clinical trials. All translation workflows operate within a secure environment designed to protect sensitive information, including protected health information (PHI) and personally identifiable information (PII).

The system is fully aligned with key regulatory frameworks, including GDPR, HIPAA, and FDA 21 CFR Part 11. This ensures that all data handling, storage, and access controls are compliant with both regional and international requirements for clinical documentation and electronic records.

Agentic AI continuously logs every action and decision made during the translation process, providing detailed audit trails and version control for all multilingual deliverables. These logs support inspection readiness and offer full traceability for sponsors, CROs, and regulatory bodies.

Data is encrypted in transit and at rest, and access to project content is restricted through role-based permissions. Sesen’s platform architecture is designed to support enterprise-grade security while enabling seamless integration with sponsor systems and decentralized trial platforms.

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Let Agentic AI Do the Heavy Lifting

Accelerate timelines, reduce costs, and improve translation quality with Sesen’s agentic AI platform. From protocols to patient materials, streamline every step with intelligent automation built for life sciences.

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