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English to Portuguese: Translation of an excerpt from an Investigator's Brochure General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - English This is a multinational, double-blind, randomized, parallel-group Phase 3 clinical trial evaluating the efficacy and safety of XXX plus YYY and ZZZ versus XXX plus YYY and ZZZ in first-line treatment for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous NSCLC.
Approximately 355 patients will be enrolled in each treatment arm for a total of approximately 710 patients at over 300 centers. Patients will be randomized (1:1) to receive either treatment of XXX plus YYY and ZZZ or XXX plus YYY and ZZZ for at least 4 and no more than 6 cycles, followed by the assigned blinded XXX monotherapy. Randomization will be stratified by region (according to the location of the drug depot supplying the site), sex (male/female) and smoking history (never/ever). Patients will participate in the study for approximately 13 months. This includes about 1 month of screening and at least 1 year for treatment and follow-up. Actual length of participation for individual patients will depend upon the actual duration of treatment. Minimum expected participation is approximately 1 year unless shorter due to death, withdrawal of consent, or early termination of the trial.
Source text available at: https://clinicaltrials.gov/ProvidedDocs/99/NCT02364999/Prot_001.pdf
Translation - Portuguese Estudo clínico de Fase III multinacional, duplo-cego, randomizado, de grupos paralelos que avalia a eficácia e a segurança de XXX combinado com YYY e ZZZ comparados com XXX combinado com YYY e ZZZ no tratamento de primeira linha de pacientes com CPNPC não escamoso avançado (irressecável, localmente avançado, recorrente ou metastático).
Aproximadamente 355 pacientes serão incluídos em cada braço de tratamento para que se obtenha um total de aproximadamente 710 pacientes em mais de 300 centros. Os pacientes serão randomizados (1:1) para receber o tratamento com XXX combinado com YYY e ZZZ ou XXX combinado com YYY e ZZZ por, no mínimo, quatro e, no máximo, seis ciclos, seguido pela monoterapia com XXX em caráter cego designada. A randomização será estratificada por região (de acordo com a localização do depósito do medicamento que abastece o centro), sexo (masculino/feminino) e histórico de tabagismo (nunca/já fumou). Os pacientes participarão do estudo por aproximadamente 13 meses. Isso inclui cerca de um mês de triagem e, no mínimo, um ano de tratamento e acompanhamento. A real duração da participação individual dos pacientes dependerá da real duração do tratamento. A participação esperada mínima é de aproximadamente um ano, a menos que ela seja mais curta devido a óbito, retirada do consentimento ou término prematuro do ensaio.
Texto original disponível em: https://clinicaltrials.gov/ProvidedDocs/99/NCT02364999/Prot_001.pdf
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Years of experience: 16. Registered at ProZ.com: Oct 2016.
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Bio
EN-PT[BR] Pharma Translation Specialist
I have been a full-time medical/pharma translator since 2007. I have a degree in Translation and another in Portuguese and English Languages and Literature.
I specialise in clinical trials (Investigator’s Brochure, Clinical Study Protocol, CIOMS Form, Informed Consent Form, Package Leaflet, Salesforce Training, Summary of Clinical Efficacy, pre-submission meeting draft, and CEP/CONEP System communication letters).
In order to improve my knowledge of Clinical Trials, I took a course on the development of Professionals working in Clinical Trials (Invitare). This allowed me to better understand all the research steps, know and understand Anvisa's resolutions and ICH guidelines, improve my knowledge of terminology and provide more accurate translations.
I'm qualified to provide translation, editing, proofreading, and machine translation post-editing services.
My average daily output is 5,500 new words. I'm detail-oriented and skilled at recreating PDF formatting. I'm also responsive, knowledgeable, and highly-committed to deadlines.
The CAT-tools and other software I usually work with are:
