背景
A novel device pursued parallel CE and NMPA registration—clinical evaluation and trial materials needed in bilingual form for CROs, ethics committees and authorities.
成果
Ethics committee and CRO confirmed English trial docs ready for multicenter studies
サービス内容：
対応言語：
プロジェクトの課題
Clinical terminology
Endpoints and AE classification per standard usage.
Ethics tone
ICF language per ethics review conventions.
Dual pathways
Different EU MDR vs. NMPA clinical language.
Complex tables
Statistics tables and footnotes preserved.
アプローチ
品質、コンプライアンス、納期のバランスを取った段階的納品。
Regulatory alignment
Confirm target markets, doc types and authority expectations.
Medical glossary
IFU/label/clinical glossary and do-not-translate lists.
Med TEP + DTP
Medical linguists, second review and layout fidelity.
Submission packaging
Organized deliverables per filing templates and change logs.
成果物
Project highlights
Clinical fluency
GCP and literature context.
Data accuracy
Tables and stats terms precise.
Ethics tone
Professional ICF language.
Dual pathway
Parallel CE/NMPA support.