This site uses cookies.
Some of these cookies are essential to the operation of the site,
while others help to improve your experience by providing insights into how the site is being used.
For more information, please see the ProZ.com privacy policy.
Freelance translator and/or interpreter, Verified site user
Data security
This person has a SecurePRO™ card. Because this person is not a ProZ.com Plus subscriber, to view his or her SecurePRO™ card you must be a ProZ.com Business member or Plus subscriber.
Affiliations
This person is not affiliated with any business or Blue Board record at ProZ.com.
English to Spanish: Clinical Trial Design Consideration General field: Medical Detailed field: Medical: Instruments
Source text - English Clinical Trial Design Consideration
Clinical trials involving medical devices pose some unique challenges as compared to clinical trials involving drug products. Unlike drug trials, which have well-defined phases as specified in drug regulations, FDA does not typically require companies to perform device trials in a pre-defined series of phases. So that potential problems can be addressed before a pivotal trial is initiated, however the agency often recommends that companies perform one or more feasibility studies to identify possible problems with the device or with potential study designs.
Feasibility studies also provide valuable information that can be used to generate hypotheses and sample size estimates for future trials. Such studies are often conducted overseas in advance of a company’s efforts to gain FDA approval for conducting a clinical trial in the United States.
Kahan JS, Medical Device Development: A Regulatory Overview. Parexel 2000;171.
Translation - Spanish Consideraciones en el Diseño de Investigación Clínica
Las investigaciones clínicas de equipos médicos poseen ciertos desafíos únicos al ser comparadas con investigaciones clínicas de fármacos. A diferencia de las investigaciones de drogas, las cuales tienen fases bien definidas, según se especifica en las regulaciones de drogas, el FDA (Administración de Drogas y Alimentos) generalmente no requiere que las compañías desarrollen la investigación de instrumentos médicos en series de etapas pre-definidas. Esto es, para que los posibles problemas puedan ser abordados antes de que el estudio pivotal sea iniciado. Aun así, la agencia frecuentemente recomienda que las compañías desarrollen uno o más estudios de factibilidad para identificar posibles problemas con el instrumento médico, o con los diseños potenciales del estudio.
Los estudios de factibilidad también proveen valiosa información que puede ser usada para formular hipótesis y para estimar el tamaño de la muestra para futuras investigaciones. Estudios como estos son generalmente conducidos fuera del país, en adelanto a los esfuerzos de las compañías para obtener la aprobación del FDA para conducir una investigación clínica en los Estados Unidos de América.
Kahan JS, Medical Device Development: A Regulatory Overview. Parexel 2000;171.
English to Spanish: FDA Adverse Event Reporting System (FAERS) (formerly AERS) General field: Medical Detailed field: Medical: Pharmaceuticals
Source text - English FDA Adverse Event Reporting System (FAERS) (formerly AERS)
What is FAERS?
The FDA Adverse Event Reporting System (FAERS) is a database that contains information on adverse event and medication error reports submitted to FDA. The database is designed to support the FDA's post-marketing safety surveillance program for drug and therapeutic biologic products.
The informatic structure of the FAERS database adheres to the international safety reporting guidance issued by the International Conference on Harmonisation (ICH E2B). Adverse events and medication errors are coded to terms in the Medical Dictionary for Regulatory Activities (MedDRA) terminology.
Excerpt from www.FDA.gov/Drugs/CDERLearn. 12/1/2014.
Translation - Spanish Sistema de Reporte de Eventos Adversos del FDA (FAERS) (anteriormente AERS)
¿Qué es FAERS?
El Sistema de Reporte de Eventos Adversos del FDA (FAERS) es una base de datos que contiene información acerca del evento adverso y reportes sobre errores en medicación, sometidos al FDA. La base de datos está diseñada para apoyar el programa del FDA de vigilancia de seguridad post-mercado para drogas y productos biológicos terapéuticos.
La estructura de informática de la base de datos de FAERS se adhiere a la guía internacional de reporte de seguridad publicada por la Conferencia Internacional de Armonización (ICH E2B). Los eventos adversos y errores en medicación son codificados en la terminología del Diccionario Médico para Actividades Regulatorias (MedDRA)
Extracto de www.FDA.gov/Drugs/CDERLearn 1/12/2014.
English to Spanish: The Consent Process General field: Medical
Source text - English Informed consent is more than just a signature on a form, it is a process of information exchange that may include, in addition to reading and signing the informed consent document, subject recruitment materials, verbal instructions, question/answer sessions and measures of subject understanding.
The Consent Process
Institutional Review Boards (IRBs), clinical investigators, and research sponsors all share responsibility for ensuring that the informed consent process is adequate.
Thus, rather than an endpoint, the consent document should be the basis for a meaningful exchange between the investigator and the subject.
Excerpt from www.FDA.org/Medical Devices/CDRHLearn 12/1/2014.
Translation - Spanish El Proceso de Consentimiento
El consentimiento informado es más que una firma en un formato, es un proceso de intercambio de información que puede incluir, además de leer y firmar el documento de consentimiento informado, materiales de inscripción de pacientes, instrucciones verbales, sesiones de preguntas y respuestas, y mediciones de comprensión del paciente.
Las Barras de Revisión Institucional (IRBs), investigadores clínicos y patrocinadores de investigación comparten la responsabilidad de asegurar que el proceso de consentimiento informado es adecuado.
Así, en vez de ser un objetivo, el documento de consentimiento debe ser la base para un intercambio significativo entre el investigador y el paciente.
Extracto de www.FDA.org/Medical Devices/CDRHLearn 1/12/2014.
More
Less
Translation education
Bachelor's degree - University of Phoenix
Experience
Years of experience: 19. Registered at ProZ.com: May 2013.
An accomplished administrative clinical and regulatory affairs professional with over 9 years of experience in the medical devices and pharmaceutical industries. Fast, reliable and accurate translator from English to Spanish with emphasis in translation of clinical trials from proof of concept to post-market surveillance.
Areas of translation expertise:
• Proof of Concept documentation
• SOPs and work instructions
• Study start-up
• Informed Consents
• Subject manual
• Monitoring reports
• Physician and patient questionnaires
• Scientific literature and publications
• News press communications
• Marketing catalogs, brochures, posters and presentations
• Study protocol and amendments
• FDA and IRB Submissions
• Subject recruitment
• Investigator manual and brochure
• Case Report Forms (CRFs)
• Adverse event reports
• Labeling
• CE mark application
• Marketing Surveillance and literature
Deep understanding of concepts, regulations and terminology pertinent to the clinical research field. Strict adherence to the Food and Drugs Administration (FDA)/European Community (CE) regulations, and Good Clinical Practices (GCP)/International Conference of Harmonisation (ICH) guidance and HIPPA regulations.
Ability to produce fast and accurate translations using medical, regulatory and technical terminology, as well as layman language, according to targeted audience and localization requirements.
Previous work experience as Clinical Trial Administrator in medical communications (Oncology and inflammation fields) for the pharmaceutical industry, as well as clinical trial administration experience in retinal and cochlear implants for the medical devices industry.
Native of Chile with a Bachelor of Science in Business Management from University of Phoenix.
This user has earned KudoZ points by helping other translators with PRO-level terms. Click point total(s) to see term translations provided.
Expertise 