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PhD in Clinical Biochemistry; Specialized Medical & Pharmaceutical Translator; Eight years of experience as a Freelance EN>ES (LA) Translator with TransPerfect (Certified in Clinical Trial Document translation); previously: 12 years in the Pharma Industry
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Freelance translator and/or interpreter, Verified site user
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English to Spanish: Fragment of Protocol Amendment General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - English This amendment aims to ensure subject safety, confidentiality, and study integrity in the context of healthcare delivery challenges presented by the COVID-19 pandemic. This guidance takes references from the FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency - Guidance for Industry, Investigators, and Institutional Review Boards, March 2020, updated 30 August 2021, and the EMA Guidance on the Management of Clinical Trials During the COVID‑19 (Coronavirus) Pandemic, Version 3 (28 April 2020).
As the COVID-19 pandemic outbreak may peak in different regions at different times and restrictions implemented by local laws and recommendations may vary, any decision on procedural changes should be made on a case by case basis following consultation with the medical monitor, with patient safety as the priority.
Translation - Spanish Esta enmienda tiene como objetivo garantizar la seguridad de los sujetos, la confidencialidad, y la integridad del estudio en el contexto de los desafíos para las prestaciones de atención médica presentados por la pandemia de COVID-19. Esta guía toma referencias de la Guía de la FDA sobre la Realización de Ensayos Clínicos de Productos Médicos durante la Emergencia de Salud Pública de COVID-19 - Guía para la Industria, los Investigadores y las Juntas de Revisión Institucional, Marzo de 2020, actualizada el 30 de Agosto de 2021, y la Guía de la EMA sobre la Gestión de los Ensayos Clínicos Durante la Pandemia de COVID-19 (Coronavirus), Versión 3 (28 de Abril de 2020).
Como el brote de la pandemia de COVID-19 puede alcanzar su punto máximo en diferentes momentos, en las diferentes regiones y las restricciones implementadas por las leyes y las recomendaciones locales pueden variar, cualquier decisión sobre los cambios de procedimientos se debe tomar caso por caso después de consultar con el monitor médico, teniendo como prioridad la seguridad del paciente.
English to Spanish: Fragment of Patient Recruiting Materials General field: Medical Detailed field: Medical: Cardiology
Source text - English The XXXXXXX Study
Dear [Patient Name],
I am writing to invite you to take part in an observational study called XXXXXXX.
You’ve been invited to take part in the XXXXXXX Study because you have already taken part in the YYYYYYY Study.
The purpose of this study is to determine the potential long-term effects of LDL-C-lowering treatments through an extended observational period of up to 10 years.
We are looking for about 10,000 patients who took part in the YYYYYYY Study to enroll in this follow-up study.
Please read on to see if you may be interested in taking part.
What is the XXXXXXX Study?
The XXXXXXX Study will only include patients who took part in the YYYYYYY Study.
The study will collect information about the medications you have taken to treat your cholesterol and whether you have been hospitalized for cardiovascular reasons.
What does the XXXXXXX Study involve?
Because this is an observational study, no medications or other treatments will be provided to you by the Sponsor as part of this study.
You will receive your usual standard-of-care treatment from your regular doctor.
You (or one of your emergency contacts) will be asked to complete a health questionnaire once a year.
The questionnaire will take 5–10 minutes to complete.
How can you learn more about the study?
As a participant in the YYYYYYY Study you can talk to the study team to see if the XXXXXXX Study might be right for you.
Their contact information is provided for you below.
Thank you for your interest in the XXXXXXX Study.
Sincerely,
[PI Name ]
Principal Investigator
The XXXXXXX Study
Translation - Spanish Estudio XXXXXXX
Estimado(a) [Nombre del Paciente]:
Le escribo para invitarlo a participar en un estudio observacional denominado XXXXXXX.
Se lo ha invitado a participar en el estudio XXXXXXX porque ya ha participado en el estudio YYYYYYY.
El objetivo de este estudio es determinar los posibles efectos a largo plazo de los tratamientos para bajar los niveles del colesterol de lipoproteínas de baja densidad durante un período observacional prolongado de hasta 10 años.
Estamos buscando alrededor de 10.000 pacientes que participaron en el estudio YYYYYYY para que se inscriban en este estudio de seguimiento.
Siga leyendo para ver si puede estar interesado en participar.
El estudio XXXXXXX sólo incluirá a los pacientes que participaron en el estudio YYYYYYY.
El estudio recopilará información sobre las medicaciones que ha tomado para tratar su colesterol y si ha sido hospitalizado por motivos cardiovasculares.
¿Qué implica el estudio XXXXXXX?
Debido a que este es un estudio observacional, el patrocinador no le dará ningún medicamento ni otros tratamientos como parte de este estudio.
Continuará recibiendo su tratamiento habitual, según el estándar de atención, por parte de su médico de cabecera.
A usted (o uno de sus contactos de emergencia) se le pedirá que complete un cuestionario de salud una vez al año.
Completar el cuestionario tomará de 5 a 10 minutos.
¿Cómo puedo obtener más información sobre el estudio?
Como participante en el estudio YYYYYYY, puede conversar con el equipo del estudio para ver si el estudio XXXXXXX podría ser adecuado para usted.
Su información de contacto se proporciona a continuación.
Gracias por su interés en el estudio XXXXXXX.
Atentamente,
[Nombre del Investigador Principal]
Investigador Principal
Estudio XXXXXXX
English to Spanish: Fragment of Investiator's Brochure General field: Medical Detailed field: Medical: Oncology
Source text - English -Case 1111111 (PT: Respiratory distress) involved a 40-year-old female with metastatic BC and a relevant medical history of shortness of breath, cough, fungating tumor mass and hyperglycemia. Twenty-two days after the first and 8 days after the most recent infusion of 10 mg/kg [Study Drug] the subject was presented to the hospital with a 2 to 3-day history of fever, chills, tachycardia, weakness, and increased dyspnoea on exertion from Baseline. The subject had increased sputum production and cough requiring 6 L via nasal cannula, bilateral rhonchi and right middle lobe crackles on initial exam. The subject was started on antibiotics for broad spectrum coverage for suspected lung source of infection. A chest CT scan showed an increase in the size and number of metastatic lesions, including necrotic pulmonary metastases, lymph nodes, and cutaneous nodules, bilateral dependent atelectasis, mild mediastinal edema, and peribronchovascular ground glass opacities. Chest X-rays indicated nodular pulmonary metastases, superimposed pulmonary vascular congestion, and mild pulmonary edema. Prednisone was administered. The subject has been transferred to ICU multiple times for respiratory distress and was treated with morphine elixir and furosemide, 40 days after study treatment start the subject passed away due to respiratory distress and sepsis (both Grade 5). No autopsy was performed. The Investigator assessed the event respiratory distress as related and the event sepsis as not related to [Study Drug] and cited the disease under study as a causal factor for the events as well as the history of cough and fungating tumor mass as suspected to be related to the event.
Translation - Spanish -El caso 1111111 (Término Preferido [TP]: Dificultad respiratoria) involucró a un sujeto de sexo femenino y 40 años de edad con cáncer de mama (breast cancer, BC) metastásico con antecedentes médicos relevantes de falta de aliento, tos, masa fúngica tumoral e hiperglucemia. Veintidós días después de la primera infusión y 8 días después de la infusión más reciente de 10 mg/kg de [Fármaco en Estudio], la paciente se presentó al hospital con antecedente de 2 a 3 días de fiebre, escalofríos, taquicardia, debilidad y aumento de disnea por esfuerzo desde el inicio del tratamiento del estudio. La paciente tenía una mayor producción de esputo y tos, que requirió de 6 litros mediante cánula, ruidos bilaterales y crepitaciones del lóbulo medio derecho en el examen inicial. La paciente inició antibióticos para cobertura de amplio espectro por sospecha de infección de origen pulmonar. Una tomografía computarizada (TC) de tórax mostró un aumento en el tamaño y la cantidad de lesiones metastásicas, que incluían metástasis necróticas pulmonares, de ganglios linfáticos y de ganglios cutáneos, atelectasia dependiente bilateral, edema del mediastino leve y opacidades en vidrio esmerilado peribroncovasculares. Las radiografías torácicas indicaron metástasis ganglionares pulmonares, congestión vascular pulmonar superpuesta y edema pulmonar leve. Se le administró prednisona. La paciente fue transferida a la unidad de cuidados intensivos (intensive care unit, ICU) múltiples veces por la dificultad respiratoria y fue tratada con elixir de morfina y furosemida; 40 días después del inicio del tratamiento del estudio la paciente falleció por dificultad respiratoria y sepsis (ambos de Grado 5). No se realizó una autopsia. El investigador evaluó el evento de dificultad respiratoria como relacionado y el evento de sepsis como no relacionado al [Fármaco en Estudio] y mencionó a la enfermedad en estudio como un factor causal para los eventos, así como los antecedentes médicos de tos y la masa tumoral fúngica como presuntamente relacionados con el evento.
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Other - AEXALEVI (Asociación de Ex Alumnos del Profesorado en Lenguas Vivas Juan R. Fernández) Buenos Aires, Argentina
Experience
Years of experience: 7. Registered at ProZ.com: Sep 2024.
English to Spanish (Biochemistry Degree (Argentina: Universidad de Buenos Aires)) English to Spanish (PhD in Clinical Biochemistry (Argentina: Universidad de Buenos Aires))
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N/A
Software
Adobe Acrobat, Microsoft Excel, Microsoft Office Pro, Microsoft Word, Powerpoint, Smartling, Wordfast, XTM
Professional objectives
Meet new translation company clients
Meet new end/direct clients
Network with other language professionals
Get help with terminology and resources
Stay up to date on what is happening in the language industry
Buy or learn new work-related software
Improve my productivity
Bio
I hold a degree in Biochemistry and a PhD in Clinical Biochemistry from the University of Buenos Aires, Argentina.
For the past eight years, I have worked as a full-time freelance English-to-Spanish translator with Transperfect, where I am certified in translating a wide range of Clinical Trial-related documents. These include Investigator's Brochures, Clinical Research Protocols, Serious Adverse Event Reports, Informed Consent Forms, Package Inserts, Laboratory Manuals, and more.
Additionally, I have 12 years of experience as a Central Laboratory Project Manager at Q2 Solutions (formerly Quintiles Laboratories, now IQVIA Laboratories), where I managed multiple Central Laboratory Service projects for Phase II and III Clinical Trials across various diseases and therapeutic areas, including Hepatology, Endocrinology, Oncology, Cardiology, Neurology, Psychiatry, and more. During this time, I gained an in-depth understanding of Clinical Research Protocols and Central Laboratory Documentation, and I also served as a certified in-house translator, providing English-to-Spanish translations for these documents.
Earlier in my career, I spent 11 years teaching and conducting research at the University of Buenos Aires, specializing in Clinical Biochemistry, Pharmacology, Cardiology and Diabetology.
I am passionate about delivering high-quality work, with a strong emphasis on attention to detail to ensure excellence in every project. I pride myself on being reliable, responsible, ethical, and fully compliant with industry standards.
With my extensive background in both Medical and Pharmaceutical fields, I am well-equipped to provide accurate and high-quality translations. I look forward to assisting you!
Expertise