Sample documents for translation

informed consent forms
trial audit
audit certificate and report
case report forms
clinical trial report
clinical trial agreements

periodic reports
adverse event reports
trial monitoring plan
trial monitoring report
trial protocols
GDPR documentation
marketing and HR content
patient diaries

Cross-cultural adaptation i Linguistic Validation

On the Polish market, only Omero offers dedicated cross-cultural adaptation and linguistic validation processes for translations of content for patients. Data collected from patients are essential for drawing conclusions and, as a result, affect the study results. An inaccurate translation of a question in the questionnaire may cause a patient to give an evasive answer (“I don’t know” or “not applicable”) or not answer at all. It leads to imprecise clinical trial results as well as financial and time losses. In order to ensure unambiguity in the proper understanding of content by clinical trial participants, in the translation of study records we recommend a reliable process of linguistic validation and cross-cultural adaptation, thanks to which we may be sure that our texts are as precise as possible and do not leave any linguistic possibilities for overinterpretation or doubts in study participants giving information. We recommend the process of cross-cultural adaptation and linguistic validation when translating the clinical outcome assessments (COA), patient reported outcomes (PRO), patient informed consent forms and questionnaires.

Expert Committee

The two stages of the linguistic validation process – harmonization and reconciliation – take place in the form of an Expert Committee. It is a meeting during which independent experts share their diverse knowledge in order to develop a single, most precise version of a translation. Such a meeting is also offered following a pilot study. The committee’s decisions and recommendations are entirely based on scientific rules and are aimed at patient safety and health as well as maximum reliability and proper validation of a clinical trial.

Translation of study records

Thanks to our knowledge confirmed by ISO 9001, ISO 17100 and ISO/IEC 27001 certificates, we provide the highest level translations according to the regulations on clinical records (MDR, IVDR) and requirements of the entities responsible for the registration of medicinal products.

A team of specialist translators of clinical trial records

Translators have specialist medical and multi-disciplinary knowledge which they constantly broaden in order to provide translations that are in line with current regulations and the adopted standards and rules of good clinical practice (GCP). Our priority is to provide a team of translators who are able to use both specialist terminology and language that is understandable for patients, which guarantee effective translation of the entire clinical trial records.

Many years of experience in the translation industry

Our services are particularly aimed at pharmaceutical and biotechnological companies, university research centres and independent Contract Research Organizations (CRO) that conduct clinical trials worldwide. We also make translations for entities responsible for the preparation of medicinal product registration documents and international Language Service Providers (LSP). The majority of translations of clinical records are into English, German, French, Russian, Polish, Spanish, Portuguese as well as other European and non-European languages. We ensure a multi-step process of internal quality control, verification and proofreading conducted by native speakers of the target language. Thanks to this, we are able to issue a Certification of Translation Accuracy (CTA) certificate for each project completed, confirming the reliability of the translation prepared by our company.

Our services

certified translations
linguistic validation
data archiving

Our experience supports our clients