COMED has a 20-year history in providing specialized translations of all the reports, protocols and materials involved in clinical trials. Our expertise is founded on a perfect combination of language and subject-area skills on top of long-standing experience in related issues, including legal. You can rely on us for command of style, precision and top quality in terms of factual accuracy and visual presentation.
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Clinical trial materials |
Specialist translations of clinical trial protocols and synopses.
Long-standing experience
Medical expert knowledge
An understanding of medical statistics and biometrics
Familiarity with applicable requirements (e.g. GCP Regulation, EU Directive 2001/20/EC)
Specialist translations of informed consent forms
Accessible language that patients will understand
Familiarity with the usual recommendations of the competent bodies
Familiarity with country-specific data protection and insurance requirements
At your request, we will identify and adapt sections of text likely to attract ethics committee criticism.
Specialist translations of case report forms and questionnaires as:
Forms for printing out
Electronic forms
Reliable content and subject expertise
Tidy presentation
Further modifications can be provided at the customer's specific request, such as:
Adaptation to suit local circumstances
Adaptation to the needs of the target group
Exact reproduction of the original format (for computer readability)
Specialist translations of accompanying materials for clinical trials, such as:
Subject diaries
Dosing instructions
Questionnaires
Recruitment posters
Accessible language that patients will understand
Questionnaires/surveys: translations based on validated material and source research
Clearly structured presentation of tabular documents
At the customer's specific request: exact reproduction of the original format (for computer readability)
Specialist translations of:
Interim and final reports
Associated documentation
Expert medical knowledge
Command of style and language
We are familiar with the regulatory and official requirements for clinical trials of medicinal products and medical devices
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Correspondence with ethics committees and regulatory authorities |
Specialist translation of correspondence with official agencies in English and German
High reliability
Long-standing experience in regulatory affairs
Absolute deadline compliance
Express delivery is always an option
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Legal |
Specialist translations of legal texts in a medical context, such as:
Investigator agreements
Consultancy agreements
Confidentiality agreements
Quality assurance agreements
An understanding of the medical and legal issues involved
Specialist medical language
Specialist legal terminology
We are court-certified
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Official documents |
Specialist translations of proficiency tests, round robin tests and laboratory performance texts into English
Long-standing experience
Extensive terminology database
Certified translations
Specialist translations of the correspondence and forms involved in clinical trials, for example:
After treatment of a patient
For reporting and documentation purposes
Expert medical knowledge
Familiarity with the jargon, including medical abbreviations
At the customer's specific request, we can render reported side effects in MedDRA terminology
Translations of curricula vitae (résumés)
Intercultural competence
Long-standing expertise
At the customer's specific request: delivery in a consistent, clear and concise format