Our team combines their academic knowledge and their research skills in order to elaborate accurate scientific and medical documentation, placing the specific information at the right level for the intended audience.

Translation & Medical Writing

Translation

Our team is highly qualified (MSc, MD and PhD levels) and fully trained, possessing expertise in science, analytics, and therapeutic practices. In this way, CETERA also provide comprehensive and flexible medical translation services with experience in the translation of a diversity of English medical documents, such as SmPC and patient documentation, into the Portuguese language. Additionally, we have a vast experience in the preparation of adverse events files, including translation of all clinical documents to English.

DOCUMENT LIST FOR TRANSLATION:

  • Summary of Product Characteristics (SmPC);
  • Informed Consent Form;
  • Patient Card;
  • Study Synopsis;
  • Regulatory documents;
  • Labelling;
  • Data Protection documents;
  • Financial and other Legal Agreements;
  • Investigator Brochure;
  • Instructions for use;
  • Case Report Forms;
  • Safety Data Sheets;
  • Equipment User Instructions;
  • Medical Questionnaires and Scales;
  • Periodic Safety Update Reports;
  • Source documents – pharmacovigilance;
  • Patient information Leaflets;
  • Doctor and patient Guides;
  • Other Regulatory Information.

Medical Writing

Medical Writing is about communicating clinical and scientific data information. It can be a complex and challenging task, since the medical vocabulary is very specific. Our team combines their academic knowledge and their research skills in order to elaborate accurate scientific and medical documentation, placing the specific information at the right level for the intended audience.

CETERA has experience working in a broad range of therapeutic areas, mainly in the cardiovascular field. Our team can assist in the development of a wide range of documents, including clinical study protocol, clinical study reports, patient narratives, DSMB updates, regulatory submissions and other documents involving study data. We work closely with the investigators and the sponsor in order to deliver accurate documents to the highest ethical and scientific standards.

Our Medical Writing services also include the preparation of manuscripts for publication in medical journals, scientific communications, education material and medical writing consultancy.

For further information or to get a quote this service, contact us.