Clinical Research
Wilkens Medical Translations is the preferred translation partner of many global Contract Research Organisations (CROs) conducting clinical trials for international pharmaceutical companies. Additionally, we work with clinical research departments of pharmaceutical companies directly.
We translate documentation for the following clinical research phases:
Phase II: Efficacy study of a medicinal product in a small patient population
Phase III: Efficacy study of a medicinal product in a large patient population
Phase IV: Efficacy study of a medicinal product after authorisation.
Wilkens Medical Translations translation services include the following document types:
- Patient Informed Consent Forms (ICF)
- Clinical Study Protocols and Case Report Forms (CRF, eCRF)
- Investigator’s Brochures
- Patient Questionnaires
- Patient Diaries
- SAE-related documents, such as CIOMS and laboratory reports
- IRB documents, IEC documents and other regulatory documents, such as letters of approval and membership lists.
These documents often need to be translated to very tight deadlines. Having your translations done by Wilkens Medical Translations means you can rest assured your translations will be delivered on time. If the next step in your process includes more translation work, e.g. amendments, discuss this with your account manager beforehand. We will do what it takes to ensure that your translations required for this next step are also delivered on time.
Clinical Research Translation
Clinical research is governed by a complex regulatory system. All European Union member states are actively involved in research into new medicinal products and the subsequent authorisation process. Documentation is often published in multiple countries in Europe and elsewhere. Strict deadlines apply to the different phases of this research.
Wilkens Medical Translations delivers high-quality translations that require few, if any, correction rounds. These translations, our professional project management and tight delivery times support the smooth running of your research and authorisation phases. We only work with specialist medical translators with extensive clinical research experience.
Should you so require, we can also issue a certificate with your translation. This signed and dated certificate is your guarantee that the translation is a true rendition of the source text.
You will find additional information about our clinical research-related translations on the following pages:
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