FOR CLINICAL RESEARCH, LIFE SCIENCES, AND PHARMACEUTICAL TEAMS
Multilingual AI to Power Regulatory Compliance
Accelerate study execution and regulatory timelines with AI-driven translation validated by expert medical linguists. LILT helps trial managers improve patient engagement, ensure data accuracy, and speed study start-up and close to accelerate drug submissions.
The LILT Difference
Regulatory-Grade Precision
Meet the highest standards for translation accuracy and terminology consistency across clinical protocols, patient materials, and regulatory documentation—validated by certified medical linguists.
Human-in-the-Loop Quality Assurance
Pair adaptive AI with domain-trained human reviewers who verify every translation for clinical accuracy, readability, and compliance with FDA, EMA, and ICH-GCP requirements, as well as MEDRA terminology.
Integrated Clinical Workflows
Ability to connect directly to eTMF, EDC, and CTMS environments to automate translation within existing study and submission workflows.
existing study and submission workflows. Data Security and Compliance
Protect patient information and study integrity with HIPAA, GDPR, and ISO 27001–aligned translation processes featuring encryption, audit trails, and secure deployment options.
Use Cases
Informed Consent and Patient Materials
Translate informed consent forms, patient portals, recruitment ads, and patient diaries to ensure comprehension and compliance across all study sites.
Clinical Trial Documentation
Translate labeling, Instructions for Use (IFUs), SmPCs, PILs, and regulatory correspondence within strict Health Authority timelines.
Pharmacovigilance and Safety Reporting
Translate adverse event reports, safety narratives, and signal detection data accurately to maintain compliance and ensure timely escalation through local & global drug safety teams.
Training and Study Enablement
Translate SOPs, internal training, investigator materials and global L&D materials to standardize best practices for site managers.
Post-Trial and Publication Readiness
Translate safety alerts, compliance notifications, and internal incident reports rapidly while maintaining auditability.
Regulatory & Compliance Communications
Support regulators, auditors, and global partners with accurate multilingual reports and filings.
Medical & Marketing Content
Localize HCP, site administrator, and patient-facing content, including websites, e-details, sales training, and promotional materials — while maintaining medical accuracy and brand consistency.
Benefits
Accelerate Global Trial Timelines
Reduce translation cycles and speed site activation through AI-automated, human-verified workflows.
Ensure Clinical and Regulatory Compliance
Meet international language access, documentation, and patient safety standards.
Improve Accuracy and Readability
Achieve linguistic precision with expert human review of all trial-critical and patient-facing content, ensuring patient safety.
Reduce Risk Across Submissions
Prevent costly rework, findings, or trial delays by maintaining validated translation quality at every stage.
Simplify Vendor Management
Consolidate translation, validation, and localization into a single, secure, compliant platform.
Validated Translation Workflows
Full traceability, audit logs, and reviewer sign-off to meet 21 CFR Part 11, Annex 11, and GDPR.