Medical documentation

We are specialists in medical translation.

We have a large collection of medical textbooks, reference works, dictionaries and other resources. We have a subscription to the EDQM standard terms, and our termbase includes more than 900,000 terms from the clinical SNOMED database. Our medical translation memory contains more than 140,000 sentences translated from English to Danish. We have access to the medical magazine Ugeskrift for Læger.

Among other things we have translated the following types of documents in a large number of different therapeutic areas:

Regulatory material

• SPCs, labelling and PILs for central and local MRP procedures and for national procedures (both starting from scratch and as updating projects)
• PSURs
• Risk management plans
• Scientific conclusions
• Production and batch documentation
• DHCP letters
• Rulings of the Patient Insurance Association

Clinical trials

• Clinical trial protocols
• Subject information and declarations of consent (ICF)
• Labelling for kits with trial drugs
• Investigator contracts, including agreements on finances and publication
• Patient cards with emergency numbers
• Patient diaries
• Patients’ medical records, discharge summaries etc.
• Check-lists and notifications of clinical trials
• Correspondence with authorities, including ethical committees

General

• Treatment guides for biological medicines
• Tender documentation in connection with biological medicines
• Form for a mini-HTA and instructions for filling it in
• Scientific articles from Ugeskrift for Læger
• Materials for use by patient associations
• Critical articles in the press (for use at pharmaceutical companies’ global headquarters)
• Material to keep politically interested parties informed and up to date on specific diseases