Scenario: FDA Reviewers Need a Chinese Clinical Trial Report in English
A Chinese pharma company filing with the FDA needed 12 documents translated: clinical reports, drug labels, adverse event reports, SCI paper abstracts. PDFTranslate processed them, then a medical translator reviewed.
Document Types and Challenges
Clinical case reports (3 pages): Patient info, medication records, disease progression — high terminology density.
Drug labels/package inserts (5 pages): Indications, contraindications, dosage tables — complex table structure.
Adverse event reports (2 pages): Highly standardized terminology, but abbreviations like "QD" (once daily) are prone to mistranslation.
SCI paper abstracts (8 pages): Structured IMRAD format with statistical terminology.
Results
| Document Type | Terminology Errors/1000 chars | Number Precision | Table Accuracy |
|---|---|---|---|
| Clinical reports | 3.2 | 99.8% | 95% |
| Drug labels | 2.1 | 100% | 97% |
| Adverse events | 1.5 | 99.5% | N/A |
| SCI abstracts | 4.8 | 100% | N/A |
The Near-Miss
"QD" (Latin "quaque die", once daily) is standard in drug labels. EN translation "once daily" is correct. But on another document, AI misread "D" as abbreviation for "Dose", confusing the entire medication frequency.
The medical translator caught it during review. If that version had gone directly to the FDA, it could have triggered reviewer questions.