In today’s global clinical research environment, clinical source documents are generated in multiple languages across investigator sites, requiring accurate and timely translation to ensure pharmacovigilance compliance. Traditional manual translation processes are labor-intensive, error-prone, and costly, introducing delays and quality risks in safety data review and reporting.
Cloudbyz has developed an AI-powered source document translation solution purpose-built to address these challenges in the safety and pharmacovigilance domain. Built natively on the Salesforce platform and integrated within the Cloudbyz Safety & Pharmacovigilance solution, this innovation streamlines global clinical safety workflows, improves quality, and accelerates regulatory reporting.
As clinical trials expand globally, sponsors and CROs engage sites in Asia, Europe, Latin America, and the Middle East. Consequently, unstructured documents such as medical records, discharge summaries, and narrative reports are submitted in native languages. These documents are critical to:
Case processing: Clinical reviewers rely on accurate translations to assess seriousness, causality, and expectedness of adverse events.
Regulatory compliance: Health authorities such as the FDA, EMA, PMDA, and Health Canada require standardized formats and translations for expedited and periodic reporting.
Signal detection: Source documents feed into pharmacovigilance databases, impacting safety signal evaluation and risk-benefit assessments.
Manual translation cannot scale to meet the increasing volume, speed, and quality expectations in safety operations.
Organizations face significant pain points with legacy translation workflows:
Safety teams often wait days or weeks for third-party translations, delaying case triage, narrative drafting, and submission.
Language nuances, abbreviations, and medical terminology can be lost or mistranslated by non-specialized linguists, affecting case assessment accuracy.
Manual translation is expensive at scale and adds layers of coordination, review, and rework—particularly in high-volume environments.
Delayed or poor-quality translations compromise regulatory timelines (e.g., 7-day, 15-day serious adverse event submissions) and increase inspection readiness risks.
Cloudbyz has introduced an AI-powered Clinical Source Document Translation Engine, integrated seamlessly within its unified Safety & Pharmacovigilance platform. This solution leverages advanced natural language processing (NLP), medical ontologies, and machine learning models trained specifically on clinical and pharmacovigilance content.
Multi-language OCR and translation: Automatically extracts and translates scanned or digital documents in over 40 global languages into standardized English.
Context-aware translation: Understands and preserves clinical context using domain-specific AI trained on adverse event narratives and medical dictionaries (e.g., MedDRA, SNOMED).
Automated metadata tagging: Identifies and annotates key safety elements like patient identifiers, adverse events, drug names, and outcomes for downstream case processing.
Human-in-the-loop workflows: Enables safety reviewers to validate and approve translations within the same interface, preserving audit trails.
The Cloudbyz AI-powered translation solution unlocks multiple benefits across clinical safety operations:
Translate documents in minutes instead of days, enabling faster triage, assessment, and submission to regulatory authorities.
AI models trained on life sciences content ensure greater fidelity in clinical meaning, reducing misinterpretation and rework.
Integrated into Cloudbyz Safety workflows, the solution reduces manual handoffs, accelerates case intake, and enhances productivity.
Easily handles high volumes of multilingual documents from global trials, supporting rapid expansion into new geographies without operational bottlenecks.
Supports compliance with ICH E2B(R3), FDA 21 CFR Part 314.80, EU GVP Module VI, and other safety guidelines by ensuring timely and auditable translations.
Organizations leveraging Cloudbyz’s AI translation engine have reported:
60–80% reduction in translation turnaround time
40% cost savings compared to outsourced translation services
Enhanced quality and completeness of safety narratives
Faster time-to-submission for SAE/ADR reports
Improved inspection readiness and compliance confidence
For example, a global medical device sponsor conducting post-market surveillance across 20 countries used Cloudbyz to automate translation of over 1,500 adverse event source documents per month, cutting down processing time from 5 days to under 24 hours.
As life sciences organizations modernize safety operations, AI-powered translation becomes a strategic enabler for speed, scale, and compliance. Cloudbyz is proud to lead this transformation with its intelligent source document translation engine, seamlessly integrated within its Salesforce-native pharmacovigilance platform.
With Cloudbyz, clinical safety teams can eliminate bottlenecks, improve data quality, and ensure global compliance—advancing patient safety with confidence.