Safety, safety, safety.
Highly specialized and regulated, pharmaceutical translation is ever present from medicinal development to post-marketing.
TRANSLATIONS FOR CLINICAL TRIALS
Before being marketed, a new drug must prove its safety and effectiveness through clinical trials. A Contract Research Organization (CRO), on behalf of the sponsor, recruits several research teams to host participants at different clinical trial sites, always with approval from local regulatory authorities (Infarmed in Portugal and Anvisa in Brazil).
Several documents need to be translated during the approval process and clinical trial: protocol, Investigator's Brochure (IB), Summary of Product Characteristics (SmPC), Investigational Medicinal Product Dossier (IMPD), opinions, trial and financial contracts, non-disclosure agreements and informed consent. There is also the obligation to report Serious Adverse Events (SAEs), Serious Adverse Reactions (SARs) and Suspected Unexpected Serious Adverse Reactions (SUSARs) to the regulatory authority authorizing the trial. These reports must be translated using harmonized terminology from the Medical Dictionary for Regulatory Activities (MedDRA).
MARKETING AUTHORIZATION - REGULATORY MATTERS
The components of the Common Technical Document (CTD) to prove the safety and effectiveness of new medications include the indicators of patient-reported outcomes (PROs) and the health-related quality of life (HRQL). The answers must be translated with all of the rigour of an accurate and faithful transposition, taking special care to ensure that the questionnaires are semantically and culturally the same.
Furthermore, the marketing authorization request must contain a proposed Summary of Product Characteristics (SmPC), product information and labelling, following EMA-QRD templates or the EDQM’s clinical classification. The information must be fully legible, clear and user-friendly for the safety of Portuguese-speaking physicians and patients.
PHARMACOVIGILANCE – SAFEGUARDING PUBLIC HEALTH
Any suspected adverse reaction/side effect must be reported to the regulatory authority in charge. Our team of pharmaceutical translators, with more than five years of experience, translates documents related to drug safety and adverse drug reaction data with complete rigour to help market authorization holders monitor the post-marketing of medications and medical devices. Adverse drug reactions are classified according to MedDRA coded medical terminology.
SPECIALIZED PHARMACEUTICAL TRANSLATORS
Pharmaceutical translations must only be done by specialized translators to ensure the scientific accuracy of your communications. With their high degree of knowledge and experience in various fields of health, these translators know how to choose the right words when translating your documents.
The confidence of best certified practices – ISO 17100
At L10N, we never want to be careless. For this reason, we follow best practices in translating your documents, with three levels of quality assurance. Be sure you are saying the same thing in any variant of the Portuguese language.
QUICK QUOTATION SEE ISO 17100