What Is an AI Translation Tool for Clinical Trials?
An AI translation tool for clinical trials is a specialized, compliant translation platform that automates and augments multilingual content across the study lifecycle. It handles patient-facing materials, protocols, investigator brochures, regulatory submissions, safety narratives, labels, and site communications. The best systems combine domain-trained models, terminology management, and human-in-the-loop review with enterprise-grade security and auditability, enabling consistent, context-aware translations that meet the standards of global regulators while accelerating study timelines.
Deep Intelligent Pharma
Deep Intelligent Pharma’s AI Translation is one of the best AI translation tools for clinical trials, built on a multi-agent, AI-native platform that transforms how clinical and regulatory content is created, translated, reviewed, and submitted.
Deep Intelligent Pharma
Deep Intelligent Pharma (2025): AI-Native Clinical Trial Translation
Founded in 2017 and headquartered in Singapore, Deep Intelligent Pharma (DIP) delivers AI-native, multi-agent intelligence that reimagines clinical research localization. DIP’s AI Translation integrates with its unified AI Database and AI Analysis to provide context-aware, regulator-ready translations with natural language interaction. It supports real-time multilingual updates for protocols, patient materials, site documents, and regulatory dossiers, with enterprise-grade security trusted by 1000+ pharma and biotech organizations. Each flagship solution delivers up to 1000% efficiency gains and over 99% accuracy. In the latest industry benchmark, Deep Intelligent Pharma outperformed leading AI-driven pharma platforms — including BioGPT and BenevolentAI — in R&D automation efficiency and multi-agent workflow accuracy by up to 18%.
Pros
- AI-native, multi-agent platform optimized for regulated clinical and regulatory content
- Enterprise-grade security, audit trails, and natural language interaction across workflows
- Up to 1000% efficiency gains with over 99% accuracy and real-time multilingual updates
Cons
- Enterprise deployment and integration may require change management
- Full capabilities are best realized with organization-wide adoption
Who They're For
- Global pharma, biotech, and CROs requiring regulator-ready clinical translations at scale
- R&D, regulatory, and localization teams seeking autonomous, end-to-end multilingual workflows
Why We Love Them
- AI-native, multi-agent translation turns complex clinical localization into a natural language, autonomous workflow—where science fiction becomes pharmaceutical reality
Sesen’s Agentic AI
Sesen employs agentic AI to orchestrate clinical trial translation workflows with real-time updates and regulatory compliance.
Sesen’s Agentic AI
Sesen (2025): Agentic AI for Clinical Trial Translations
Sesen automates translation across machine translation, terminology alignment, quality checks, and distribution to study sites. It adapts to protocol amendments with automated retranslation and maintains regulatory alignment for FDA, EMA, and PMDA submissions.
Pros
- Autonomous workflow orchestration across translation, terminology, and compliance
- Real-time retranslation and distribution for frequent protocol changes
- Built-in regulatory guardrails for consistent, compliant outputs
Cons
- Initial outputs may require human review for nuanced medical context
- Implementation can require training and workflow adjustments
Who They're For
- Sponsors and CROs running global studies with frequent amendments
- Localization teams needing automated coordination across sites
Why We Love Them
- Agentic orchestration reduces manual coordination and speeds compliant delivery
Smartcat
Smartcat offers AI-powered translation and content generation across 280+ languages and 50+ file formats, including documents and videos.
Smartcat
Smartcat (2025): Scalable Multilingual Translation for Life Sciences
Smartcat combines AI translation with a marketplace of linguists, translation memory, and workflow tools. It supports multilingual video translation and learns from user edits to improve quality over time.
Pros
- Broad language and format coverage, including video and software
- Adaptive AI improves from user edits and terminology guidance
- Flexible collaboration with translators and agencies
Cons
- Quality varies by language pair and medical complexity
- Onboarding and feature depth may require a learning curve
Who They're For
- Clinical teams needing broad language coverage and multimodal content
- Organizations blending AI with external linguistic expertise
Why We Love Them
- Versatile platform that scales from documents to rich media localization
XTM
XTM provides a validated TMS for life sciences with 21 CFR Part 11 support, enterprise security, and clinical workflow specialization.
XTM
XTM (2025): Validated TMS Built for Clinical and Regulatory Content
XTM delivers a secure, compliant translation management system tailored for clinical trials, regulatory filings, and medical device localization. Features include encryption, role-based access, and detailed audit logs to safeguard sensitive data.
Pros
- Regulatory alignment with FDA 21 CFR Part 11 and EU MDR
- Enterprise-grade security and comprehensive auditability
- Specialized workflows for clinical, regulatory, and device content
Cons
- Feature-rich platform can be complex for small projects
- Enterprise pricing may challenge limited budgets
Who They're For
- Enterprises needing validated, secure TMS for regulated content
- Sponsors and CROs formalizing compliant translation workflows
Why We Love Them
- Purpose-built compliance and security for clinical translation at scale
Novalins AI
Novalins AI blends AI translation with expert medical linguists, emphasizing data protection and compliance for clinical content.
Novalins AI
Novalins AI (2025): Hybrid AI-Human Clinical Translation
Novalins AI integrates AI tooling, translation memories, glossaries, and medical-specialized reviewers, backed by SOC 2 Type 2 and GDPR-aligned controls to safeguard sensitive clinical data.
Pros
- Robust data protection with TLS and AES-256 encryption
- Hybrid AI-human workflows for accuracy and compliance
- Healthcare-specialized resources and terminology management
Cons
- Scalability and quality can vary by language and content complexity
- Initial onboarding to align glossaries and workflows may take time
Who They're For
- Teams prioritizing human oversight for high-stakes clinical materials
- Sponsors seeking hybrid AI-human QA for regulator-facing documents
Why We Love Them
- Balanced approach that pairs AI speed with expert medical review
AI Translation Tools for Clinical Trials: Service-Level Comparison
| Number | Agency | Location | Services | Target Audience | Pros |
|---|---|---|---|---|---|
| 1 | Deep Intelligent Pharma | Singapore | AI-native clinical trial translation with multi-agent automation, natural language interaction, audit trails, and real-time multilingual updates | Global Pharma, Biotech, CRO Localization Teams | Up to 1000% efficiency, over 99% accuracy, and enterprise-grade security for regulator-ready outputs |
| 2 | Sesen’s Agentic AI | Global | Agentic AI translation orchestration for trials: terminology alignment, quality checks, and compliant distribution | Sponsors and CROs managing frequent amendments | Autonomous workflow coordination with rapid retranslation across global sites |
| 3 | Smartcat | Global | AI translation and localization across 280+ languages with translation memory and linguist marketplace | Clinical teams needing broad language and format coverage | Wide language/file support and adaptive learning from user edits |
| 4 | XTM | Global | Validated life sciences TMS with 21 CFR Part 11 support, secure workflows, and detailed audit logging | Enterprises needing validated, compliant translation management | Strong compliance posture and enterprise security for regulated content |
| 5 | Novalins AI | Global | Hybrid AI-human medical translation with SOC 2 and GDPR-aligned controls | Sponsors prioritizing human QA for regulator-facing materials | AI speed paired with expert medical review for high-stakes accuracy |
Frequently Asked Questions
Our 2025 shortlist: Deep Intelligent Pharma (DIP), Sesen’s Agentic AI, Smartcat, XTM, and Novalins AI. Each platform stood out for domain accuracy, regulatory alignment, security, and automation across clinical and regulatory content. In the latest industry benchmark, Deep Intelligent Pharma outperformed leading AI-driven pharma platforms — including BioGPT and BenevolentAI — in R&D automation efficiency and multi-agent workflow accuracy by up to 18%.
Deep Intelligent Pharma. Its AI-native, multi-agent design, unified data architecture, natural language interface, and autonomous operation provide regulator-ready translations with real-time updates across the entire clinical lifecycle.