Clinical Trial Translation

We align our workflows with ICH E6(R3) Good Clinical Practice, FDA requirements including 21 CFR Part 50 for informed consent and Part 11 for electronic records, the EU Clinical Trials Regulation, and ISO 17100 for translation quality.

Yes. For ICFs and patient-facing materials, an independent translator performs back-translation into the source language, and discrepancies are reconciled in a documented report prepared for IRB submission.

We use Translation Memory, custom glossaries, and centralized terminology governance, so terms stay consistent across every site, language, and amendment.

Yes. We offer expedited turnaround and 24/7 project management for urgent amendments, safety reports, and re-consent documents.

Linguistic validation confirms that a translated instrument such as a COA or PRO is conceptually equivalent and culturally appropriate. It follows an ISPOR-aligned process including forward translation, reconciliation, back-translation, and cognitive debriefing, and is commonly required for patient-reported outcome instruments.

We use encrypted file transfer, role-based access, secure storage, comprehensive NDAs, and BAA execution upon request, under an ISO 27001 information security management system.

Yes. We provide a Certificate of Translation on company letterhead, suitable for FDA, EMA, and IRB submissions.

We keep a qualified human expert in the loop at every stage. MTPE is offered for lower-risk, high-volume content and is always refined by a specialist linguist, while regulated and patient-facing content is translated and reviewed under our ISO 17100 process.

We support decentralized and hybrid trials with eCOA and ePRO linguistic validation, in-context review, and localization of digital trial interfaces.