What we work on
- Clinical trial protocols and amendments
- Informed consent forms and patient-facing material
- Investigator brochures and site documentation
- Regulatory submission content
- Product information, SmPCs and package leaflets
- Pharmacovigilance and adverse event reporting
- Patient-reported outcome instruments
- Medical and scientific publications
Why this content is different
Patient-facing text has a comprehension requirement, not just an accuracy requirement. An informed consent form has to be understood by someone who is frightened, unwell and not a clinician. Machine output tends to preserve the register of the source, which in this content is the register of a protocol. Accurate and incomprehensible is a failed consent form.
Regulatory language is prescribed. Submission content follows templates and controlled vocabularies, and deviations create queries. An engine that produces a fluent synonym for a controlled term has created work for your regulatory affairs team at exactly the moment they have the least time.
Adverse event content is time-critical and unforgiving. Under-reporting caused by a translation error is a compliance failure with a paper trail attached.
The infrastructure question is real. Content containing personal health information cannot be routed through public machine translation. GDPR requires a formal impact assessment before deploying an AI system that processes personal data, and HIPAA requires that protected health information is not retained and runs on controlled infrastructure. In this sector the constraint is often not translation quality at all — it is data handling.
What we deliver
- Reviewers matched to therapeutic area and document type, with qualifications documented and available on request.
- Separate post-editing and sign-off passes by different linguists.
- Structured error reporting against MQM, with critical findings — dosage, contraindication, negation, numerical — flagged separately from anything cosmetic.
- Version-level traceability: which protocol version, which amendment, which reviewer, which date.
- Consistent terminology across a study's document family, from protocol to consent form to site material.
- Back-translation and reconciliation where your process or your ethics committee requires it.
Languages where this matters most
Chinese, for pharmaceutical filings and for a regulatory environment where documentation is scrutinised closely. Japanese and Korean, for major clinical markets with demanding regulators and low tolerance for text that reads as translated. Arabic, for Gulf market submissions and for patient-facing material where the register and dialect decision determines whether a patient actually understands what they are consenting to. European languages, for multi-country trials where the requirement is every language and the exposure is the weakest one.