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We are specialized in translation services within clinical research and bridging the gap for clients who value quality and transparency.

About us

About us

[ əˈbaʊt ʌs ]

We are a Swiss-based specialized language service provider for contract research organizations (CROs) and pharmaceutical companies. We focus on clinical research projects throughout all clinical study phases (phases I-IV) and deliver in a highly professional and transparent manner.

ISO and GCP Certified

Highest Quality

Always on time

100% transparency

Our clients value our experienced and dedicated translation team. As our translation team has either clinical research or medical background, we are fully aware of sensitive submission timelines and the needs of our clients. Therefore, we respect a transparent correspondence in order to deliver a high-quality translation to the satisfaction of our clients. Through continuous sustainable process optimization in cooperation with our clints, we were able to constantly increase the quality of our translation services while reducing costs.

Our team faces the highest linguistic and technical challenges within the clinical research segment and related fields, leading to a highly professional handling of the specific document types.

  • Quality assurance processes for quality improvement and increased safety

  • Regulatory compliance, scientific correctness and the correct use of standardized medical terminology ensure that your studies comply with regulatory requirements and the timelines of your studies

  • Shortened time to market authorization through interdisciplinary processes that not only efficiently interact with each other but also ensure that deadlines are met right from the start

  • Reliable service with ISO and GCP certified team

  • Quality management and project management system

Our mission

[ ˈaʊə ˈmɪʃən ]

We have been working in the clinical field for many years and we know exactly what is important. We have noticed a dramatic lack of quality in clinical documents, which from our point of view were unacceptable and negligent. Since no one else corresponded to our sense of quality and accuracy, we took things into our own hands.

In the case of clinical studies in particular, a 100% accurate translation is crucial for the international exchange of knowledge. Our mission is to take translations for clinical trials to the next level. We will establish a new standard in customer cooperation, transparency and translation services to disrupt the whole Industry for the good. As we specialize exclusively in clinical studies, we will always deliver better translations than any other competitor.

Services

Services

[ ˈsɜːvɪsɪz ]

Clinical trials are increasingly being conducted multicentric across national and linguistic borders in a wide variety of countries. This internationality and thus the multilingualism of the study participants as well as the geographically determined characteristics pose a particularly great challenge for companies when conducting and evaluating the studies.

Documents we translate

[ ˈdɒkjʊmənts wiː trænsˈleɪt ]

Through our specialized translation and language solutions, we successfully manage the different types of documents, which are intended for different target groups (patients, investigators, regulatory authorities). We are aware that the translations require different processes according to the target group and study content. We provide a translation certificate for each translation.

  • AE/SAE reports

  • Patient facing material

  • Case report forms (CRFs)

  • Patient information leaflets (PLs)

  • Communication with ethics committees

  • Patient information sheet (PIS)

  • Confidentiality agreements

  • Patient-reported outcomes (PROs)

  • Contracts/ Clinical Trial Agreements (CTAs)

  • Protocols and protocol synopsis

  • Final report for clinical trials (clinical study report, CSR)

  • Recruitment & Retention material

  • Import/export permits

  • Safety reports

  • Informed consent forms (ICFs)

  • Site documentation and reports

  • Investigator’s brochures

  • Site facing material

  • Packaging and labeling of the investigational medicinal product (IMP)

  • Study newsletters

  • Patient and clinician education material

  • Study reports

  • Patient cards

  • Summaries of product characteristics (SmPC)

  • Patient diaries (e-diaries)

What to expect

[ wɒt tuː ɪksˈpɛkt ]

The specific requirements of each study require a careful project analysis in order to set up the most suitable and client-oriented translation solution. The various stages of a study require different types of documents and are often subject to sensitive timelines with extremely demanding challenges. Based on the type of clinical trials and the clients requirements, our process can be extended with additional sub-processes.

Clinical Translations, as a long-standing expert in all stages of product development and regulatory affairs, solves the requirements of multilingual clinical trials with its experienced translation and language management team with a series of well-defined process steps to deliver all documents and information accurately, understandably and localized to the respective target group and target country in the native language of the trial participants, in accordance with the GCP Guidelines.

Process

Process

[ ˈprəʊsɛs ]

Scalable and flexible translation and language management play a key role for all global pharmaceutical companies and CROs in multinational studies. Our client-centric approach, flexibility and expertise enables all global pharmaceutical companies and CROs to leverage our capabilities as a full outsource service or a partial service provider:

We are committed to the highest standards of process alignment and apply them to each stage of clinical Research. You can use the Dropdown below or download our process PDF.

01

Concept Development

  • Project plan and process plan

  • Assessment of the original text or document for translatability and target audience

  • Translation guide, style guide and briefing

  • Team allocation

02

Translation and alignment

  • Two translations of the original text or document by two independent medical translators

  • Alignment and finalization into one version by third expert translator

03

Back translation and harmonization

  • Back translation by a medical translator without knowledge of the source text or source document

  • Review of the back translation

  • Comparison of the back translation with the original document and correction of the translation from step 2, if necessary

  • Harmonization of all translation languages based on the back translation and the original text or document and correction/harmonization of the translations in step 2, if necessary

04

Debriefing and discussion

  • Preparation of the project specific debriefing protocol.

  • Debriefing interviews by professional medical team (details of the text, comprehensibility or interpretation of text, suggestions of change).

05

Preparation of the final version

  • Result analysis of the debriefing

  • Review or revision of the text or document

  • Creation of the final version

  • Proofreading

  • Final release

06

Creation of final report

  • Everything is polished and ready for the world.

Quality Assurance

Quality Assurance

[ ˈkwɒlɪti əˈʃʊərəns ]

We follow all applicable and relevant industry standards and fulfill all guidelines of DIN EN ISO 17100. In addition, we are certified according to DIN EN ISO 9001.

In order to exceed the quality standards of the pharmaceutical industry, we work in a strongly process-oriented manner. We established our own processes and tools according to the different types of documents and different customer requirements. In addition, we see ourselves as your partner and not just as a translation service provider, which means that we work with you to design systems and processes in such a way that you can expect long-term benefits such as cost reductions and shortened turnaround times, while we guarantee the same quality standards.

We not only provide precise workflow management by trained and experienced project managers with scientific and/or linguistic backgrounds but also quality checks in several steps, always adapted to the type of document and its intended use.

Our tools also vary depending on the process and systematically support the workflow:

  • From standard quality assurance (QA) to consistency and terminology tools within the pharmaceutical and medical industry.

  • Software tools for customer-specific or differentiated QAs

  • Internal QA tools based on regulatory requirements

  • Process and quality support tools such as translation memory systems and terminology databases

  • Feedback loop tools

Revision of the Initial Translation According to DIN EN ISO 17100

[ rɪˈvɪʒən ɒv ði ɪˈnɪʃəl trænsˈleɪʃən ]

An essential part of quality assurance (according to DIN EN ISO 17100) is the revision of the initial translation by a second independent language expert. This includes:

  • Sentence-by-sentence linguistic review of the translation against the source text

  • Target group and target market-relevant review/adjustment

  • Interpretation, spelling and grammar

  • Consideration of glossaries, terminology and consistency

Technical Review of the DIN 17100 Translation

[ ˈtɛknɪkəl rɪˈvjuː ]

Monolingual technical review of the translation by an independent third party expert (medical specialist, pharmacist, chemist, biochemist and life science specialist):

  • Accuracy

  • Professional understanding

  • Misinterpretation and

  • Specialized terminology

Quality Assurance Checks in a Multi-Stage System

[ ˈkwɒlɪti əˈʃʊərəns ʧɛks ɪn ə ˈmʌltɪsteɪʤ ˈsɪstɪm ]

Sustainable and long-term quality assurance is ensured by a multi-stage evaluation process during and after each project. Depending on the type of project and document, electronic quality tools and/or expert-based quality checks are used to identify and correct any discrepancies in the translation. Tools make the translation process more controllable, transparent and efficient - in other words, faster, cost-effective and of higher quality.

We offer and incorporate a comprehensive range of different testing and quality assurance steps, as translation quality testing is carried out in many different ways throughout the translation and correction process. The bilingual or multilingual glossary of a translation project is checked and validated by a technical and/or linguistic expert, taking into account the source text. If desired, the terminology adjustments can be integrated directly into existing translations to ensure terminological consistency.

Standardized methods for measuring translation quality and quality indicators are used as a basis for categorization.

A Professional Team - Project Managers, Translators, Language and Professional Experts

[ ə prəˈfɛʃənl tiːm ]

Our project management team consists of professionally and methodically trained project managers who are compliant with the processes and standards in the healthcare industry. Our team can manage small, medium and large volumes in all languages.

The project management team is interdisciplinary and consists of:

  • Certified translators

  • Scientists

  • Business economists

  • IT specialists.

Furthermore, only selected and certified experts who meet at least the following requirements are entrusted to perform the translations:

  • Native speakers of the target language

  • Medical and technical translators

  • Medical and scientific experts (medical specialist, pharmacist, chemist, biochemist, life science specialist, etc.) with appropriate degrees and in-depth linguistic expertise

  • Many years of experience in the translation and linguistic field

Please feel free to request CVs before the start of the project. At the start of the collaboration, we build up a pool of translators or experts specifically for each client to ensure consistent quality. These translators are trained specifically for your requirements.

KPIs in the Translation Process

[ keɪ-piː-aɪz ɪn ðə trænsˈleɪʃən ˈprəʊsɛs ]

Our goal is to constantly improve our performance and to continuously improve our processes. Measuring our performance is the basis for this.
The quantitative collection of "Key Performance Indicators" (KPIs) is part of every project. Time, costs or cost savings and the quality of the individual delivery are the main indicators for assessing our performance.

Data security in the Translation Process

[ ˈdeɪtə sɪˈkjʊərɪti ɪn ðə trænsˈleɪʃən ˈprəʊsɛs ]

Special security and confidentiality standards are absolutely necessary for the healthcare industry and are therefore inevitable for us. We are used to working with sensitive data and managing it securely.

Data security has two aspects:
Protection of data against unauthorized access and protection against data loss. Both aspects are guaranteed for your data. Continuously updated and repeatedly tested data security and disaster recovery/business continuity plans document our protective measures for your data.

Redundant systems backed up cross-site, strict separation of client data or encrypted email communication are our standards.

Please feel free to communicate with us. We are happy to adjust our services to your requirements.

Get a quote

Get a quote

[ gɛt ə kwəʊt ]

Every project is individual and needs individual experts. We aim for the highest translation quality in the shortest amount of time.

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