Have a study translated into German
Study documents that pass the ethics committee and the authority without objection – trial protocol, patient information and consent form consistent, comprehensible and confidential.
With clinical trials, linguistic clarity and consistency decide the approval
Whether trial protocol, investigator's brochure, patient information or consent form: we translate study documents in a regulatorily correct and internally consistent way – endpoints, procedures and safety information stay free of contradiction across all documents, and your study team is responsible for the content sign-off.
For sponsors and CROs: ready for submission under EU Regulation 536/2014
In the approval procedure the ethics committee and the federal higher authority check the documents for linguistic consistency. We deliver the language versions ready for submission for the entire study package.
Which bodies review the translated study documents?
In the approval procedure the competent ethics committee and the federal higher authority – BfArM for medicinal products, the Paul Ehrlich Institute for vaccines and biomedical medicinal products – review the documents under EU Regulation 536/2014. We deliver terminology-managed and with four-eyes revision; your study team is responsible for the content sign-off.
Do you translate the complete document package for the CTIS submission?
Yes – trial protocol, investigator's brochure, patient information, consent form as well as cover letters and ethics documents we translate as a consistent package, aligned with the submission via the EU portal CTIS.
How do you keep terminology uniform across all study documents?
With a glossary and a translation memory, endpoints, procedures, safety information and subject-matter terms stay identical across the protocol, investigator and patient information – regulatorily relevant, because divergent wording in a multinational package is treated as a contradiction in content.
Do you work to ICH-GCP?
Yes. We translate within your processes managed to ICH-GCP (E6), document versions and changes traceably and thereby support the audit and inspection readiness of your Trial Master File.
For the ethics committee: information that participants genuinely understand
Patient information and consent decide the approval, because they must be generally comprehensible. We render them professionally correct and at the same time fit for lay understanding.
Why are patient information and consent so critical for approval?
The ethics committee checks whether the information is comprehensible for participants without a medical background. We render purpose, procedure, risks and rights in a lay-comprehensible way, without altering the professional and legal statement.
Do you offer a back-translation for quality assurance?
For sensitive instruments – such as consent forms or patient questionnaires (clinical outcome assessments) – we offer back-translation and reconciliation, so that the target version matches the source exactly in content.
Do endpoints and safety information stay free of contradiction with the protocol?
Yes. Endpoints, procedures and safety information we mirror exactly against the protocol and investigator's brochure, so that the lay-comprehensible version stays congruent in content with the regulatory core documents.
For multinational trials: many languages, one deadline, strictly confidential
Multinational trials run under time pressure and high confidentiality. We deliver many language versions in parallel – consistent, on schedule and under confidentiality.
Can you deliver many target languages in parallel and on time?
Yes. For multinational trials we translate into all site languages in parallel, coordinated by a dedicated project manager, with a single delivery date and one fixed price for the entire package.
How do you protect confidential trial and study data?
Protocols, investigator's brochures and unpublished results leave our house only under control. On request we work under your or our non-disclosure agreement, limit access to a fixed team and transfer files exclusively over secure channels.
Does terminology stay preserved across amendments and follow-up versions?
Yes. For protocol amendments and follow-up versions we translate the changes against the translation memory, so that the approved terminology stays identical across all versions and language versions of the trial.
How your certified study translation works
Document and upload
Send your study as a PDF, photo or scan – we check legibility, stamps and intended use.
Fixed price in 120 minutes
You receive a binding fixed-price quote with a delivery date, clearly calculated in advance.
Professional translators and revision
Assignment to a subject-matter translator; independent revision under the four-eyes principle per DIN EN ISO 17100.
Delivered certified
Digital advance version and, on request, the certified copy by post – officially recognised.
Translate a study: German, English, French, Turkish, Spanish and over 60 languages
Whether for an authority, court, employer or university at home or abroad: we produce translations of study documents in German, English, French, Spanish, Italian, Turkish, Arabic and over 60 other languages. Only native-speaker translators with a relevant background translate; every version is revised on the four-eyes principle in accordance with DIN EN ISO 17100 and certified on request – recognised by authorities and courts.
How your fixed price for the study translation is calculated
We bill transparently by standard line (55 characters including spaces) from €0.95. The binding fixed price depends on volume, language combination, certification and the desired quality level – with no hidden costs and usually within about two hours.
Translating a study – frequently asked questions
Are the translations suitable for ICH-GCP / regulatory purposes?
We translate terminology-guided and with revision; regulatory approval is your team's responsibility. We deliver the required quality and consistency.
Does the terminology stay consistent across documents?
Yes – with a glossary and translation memory, endpoints, procedures and terms stay consistent across all study documents.
What about confidentiality?
Strictly confidential with an NDA and access restriction; GDPR-compliant.
What does it cost?
From €0.95 per standard line or as a professional translation; with a TM discount for larger volumes – as a fixed price in advance.
Which bodies review the translated study documents?
In the approval procedure, the competent ethics committee and the higher federal authority – BfArM for medicinal products, the Paul Ehrlich Institute for vaccines and biomedical medicinal products – review the study documents under EU Regulation 536/2014. We supply the translation terminology-managed and with four-eyes revision; the substantive approval is the responsibility of your study team.
How is terminology kept consistent across all study documents?
With a glossary and translation memory, endpoints, procedures, safety information and technical terms stay identical across the protocol, investigator and patient information. This consistency is regulatorily relevant, because differing wording in a multinational study package is treated as a substantive contradiction.
Regulatorily resilient translation of clinical studies
With clinical studies, comprehensibility and consistency determine approval. Alongside study documents we translate Package inserts and professional information, medical Doctor's letters and findings and medical expert reports – terminology-managed, GCP-compliant and strictly confidential. More on this in the practice area Medical translation.