Translation for a multinational clinical trial in EMEA

The client and the project are anonymised throughout.

Sector: Life sciences / clinical research

Language: English <> Dutch

Service: Human Translation & Localisation; AI Verification (post-editing)

The Challenge

A global pharmaceutical company was opening a late-stage multi-centre study of an investigational treatment for an autoimmune condition. To enrol participants, it needed the informed consent form and a plain-language protocol synopsis, translated from English into Dutch. The translations had to be medically accurate yet genuinely plain and faithful to the regulated English source; and delivered fast enough to keep the study's timeline on track.

The Solution

Guildhawk delivered patient-facing accuracy on the study timeline, inside a secure workflow:

• Assigned a qualified, native Dutch medical linguist with clinical-research experience to translate the informed consent form and the plain-language participant summary.
• Kept the plain-language register readable for participants while retaining the accuracy of clinical and regulatory terminology.
• Applied a human verification and post-editing over the draft, combining speed with a qualified human check appropriate to consent documentation.
• Preserved the document structure and formatting of the materials so the Dutch versions mapped cleanly onto the approved English source for ethics-committee review.
• Processed the project as confidential within an ISO 27001 information-security envelope, with GDPR-aware handling of personal data classifications and built reusable trial terminology for the sponsor.

The Results

The sponsor received submission-ready Dutch documents within a week:

• Translated informed consent form and plain-language protocol synopsis, ready for ethics-committee submission and participant use.
• Delivered within a six-working-day turnaround, aligned to the team's deadline.
• Plain-language clarity for participants alongside faithful, accurate clinical and regulatory terminology.
• Consistent terminology captured for reuse across the sponsor's wider trial documentation.
• Confidential, ISO 27001, GDPR-aware handling throughout, appropriate to regulated patient data.

Why this matters for clinical operations and regulatory teams in life sciences 

Trial start-ups entirely depend on the success of patient-facing documents. Translated materials must be medically exact, readable, faithful to the regulated source, and delivered inside tight submission windows across every country in the study – so they are easily reviewable by the ethics committee.

Fragmented freelance agencies and raw machine translation output put consistency and confidentiality at risk. Guildhawk pairs qualified native medical linguists with human verification, domain-specific terminology, and ISO 2700 and GDPR-aware handling, so sponsors and CROs get accurate, participant-ready translations on the study timeline, with a defensible audit trail.

About Guildhawk

Guildhawk is a British language-intelligence company founded in 2001 and headquartered in London. It combines 3,000+ vetted, certified linguists across 200+ languages with proprietary AI built in its own UK Gai Labs, delivering every project with a defensible audit trail. Guildhawk is ISO 27001 certified, a Queen's Award winner and a 2025 Safety and Security Entrepreneur Awards (SSEAs) winner, and processes work inside a secure ISO 27001 confidentiality envelope. Its GAI Suite of proprietary AI tools provides secure, advanced agents for AI translation with 1-click human-in-the-loop, anomaly detection and data anonymisation. Clients include global law firms, life-sciences, energy, financial and government organisations. 

Running a multi-country study? Talk to Guildhawk about certified and patient-facing clinical translation.