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Clinical trials

Clinical trials: for a strong clinical trial partner, count on us

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.

 

Clinical trials

Clinical trial materials

  • Study protocols and synopses

    We provide:

    Specialist translations of clinical trial protocols and synopses.

    Our strengths:

    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)

  • Informed consent forms

    We provide:

    Specialist translations of informed consent forms

    Our strengths:

    Accessible language that patients will understand
    Familiarity with the usual recommendations of the competent bodies
    Familiarity with country-specific data protection and insurance requirements

    Optional services:

    At your request, we will identify and adapt sections of text likely to attract ethics committee criticism.

  • Case report forms/CRFs

    We provide:

    Specialist translations of case report forms and questionnaires as:
    Forms for printing out
    Electronic forms

    Our strengths:

    Reliable content and subject expertise
    Tidy presentation

    Optional services:

    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)

  • Materials for clinical trial subjects

    We provide:

    Specialist translations of accompanying materials for clinical trials, such as:
    Subject diaries
    Dosing instructions
    Questionnaires
    Recruitment posters

    Our strengths:

    Accessible language that patients will understand
    Questionnaires/surveys: translations based on validated material and source research
    Clearly structured presentation of tabular documents

    Optional services:

    At the customer's specific request: exact reproduction of the original format (for computer readability)

  • Clinical trial reports

    We provide:

    Specialist translations of:
    Interim and final reports
    Associated documentation

    Our strengths:

    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

Correspondence with ethics committees and regulatory authorities

  • Correspondence

    We provide:

    Specialist translation of correspondence with official agencies in English and German

    Our strengths:

    High reliability
    Long-standing experience in regulatory affairs
    Absolute deadline compliance
    Express delivery is always an option

Legal

  • Investigator agreements

    We provide:

    Specialist translations of legal texts in a medical context, such as:
    Investigator agreements
    Consultancy agreements
    Confidentiality agreements
    Quality assurance agreements

    Our strengths:

    An understanding of the medical and legal issues involved
    Specialist medical language
    Specialist legal terminology
    We are court-certified

Official documents

  • Lab certificates

    We provide:

    Specialist translations of proficiency tests, round robin tests and laboratory performance texts into English

    Our strengths:

    Long-standing experience
    Extensive terminology database

    Optional services:

    Certified translations

  • Hospital reports, case report forms, discharge letters

    We provide:

    Specialist translations of the correspondence and forms involved in clinical trials, for example:
    After treatment of a patient
    For reporting and documentation purposes

    Our strengths:

    Expert medical knowledge
    Familiarity with the jargon, including medical abbreviations

    Optional services:

    At the customer's specific request, we can render reported side effects in MedDRA terminology

  • CVs

    We provide:

    Translations of curricula vitae (résumés)

    Our strengths:

    Intercultural competence
    Long-standing expertise

    Optional services:

    At the customer's specific request: delivery in a consistent, clear and concise format