{"id":141774,"date":"2019-10-25T12:20:55","date_gmt":"2019-10-25T19:20:55","guid":{"rendered":"https:\/\/lifesciences.csoftintl.com\/estudios-clinicos\/"},"modified":"2021-04-22T04:27:23","modified_gmt":"2021-04-22T11:27:23","slug":"estudios-clinicos","status":"publish","type":"page","link":"https:\/\/lifesciences.csoftintl.com\/es\/estudios-clinicos\/","title":{"rendered":"Estudios cl\u00ednicos"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; fullwidth=&#8221;on&#8221; _builder_version=&#8221;3.17.6&#8243; custom_margin=&#8221;|||&#8221; custom_padding=&#8221;0px|0px|0|0px|false|false&#8221;][et_pb_fullwidth_header title=&#8221;@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF90aXRsZSIsInNldHRpbmdzIjp7ImJlZm9yZSI6IiIsImFmdGVyIjoiIn19@&#8221; header_scroll_down=&#8221;on&#8221; scroll_down_icon=&#8221;%%0%%&#8221; scroll_down_icon_size=&#8221;27px&#8221; button_one_text=&#8221;Cont\u00e1ctenos ahora&#8221; button_one_url=&#8221;\/?page_id=132193&#8243; background_overlay_color=&#8221;rgba(0,0,0,0.66)&#8221; content_max_width=&#8221;80%&#8221; content_max_width_last_edited=&#8221;on|desktop&#8221; module_class=&#8221;hide-h1&#8243; _builder_version=&#8221;3.20.2&#8243; _dynamic_attributes=&#8221;title&#8221; content_font=&#8221;||||||||&#8221; content_font_size=&#8221;22px&#8221; content_font_size_phone=&#8221;17px&#8221; content_font_size_last_edited=&#8221;on|desktop&#8221; content_line_height=&#8221;1.9em&#8221; background_color=&#8221;rgba(255,255,255,0)&#8221; background_image=&#8221;https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2019\/10\/Pre-clinical-Studies-banner.jpg&#8221; parallax=&#8221;on&#8221; parallax_method=&#8221;on&#8221; custom_button_two=&#8221;on&#8221; button_two_icon=&#8221;%%34%%&#8221; button_two_on_hover=&#8221;off&#8221; custom_margin=&#8221;|||&#8221; custom_padding=&#8221;154px||80px|&#8221; custom_padding_phone=&#8221;50px||50px|&#8221; custom_padding_last_edited=&#8221;on|desktop&#8221; button_one_text_size__hover_enabled=&#8221;off&#8221; button_one_text_size__hover=&#8221;null&#8221; button_two_text_size__hover_enabled=&#8221;off&#8221; button_two_text_size__hover=&#8221;null&#8221; button_one_text_color__hover_enabled=&#8221;off&#8221; button_one_text_color__hover=&#8221;null&#8221; button_two_text_color__hover_enabled=&#8221;off&#8221; button_two_text_color__hover=&#8221;null&#8221; button_one_border_width__hover_enabled=&#8221;off&#8221; button_one_border_width__hover=&#8221;null&#8221; button_two_border_width__hover_enabled=&#8221;off&#8221; button_two_border_width__hover=&#8221;null&#8221; button_one_border_color__hover_enabled=&#8221;off&#8221; button_one_border_color__hover=&#8221;null&#8221; button_two_border_color__hover_enabled=&#8221;off&#8221; button_two_border_color__hover=&#8221;null&#8221; button_one_border_radius__hover_enabled=&#8221;off&#8221; button_one_border_radius__hover=&#8221;null&#8221; button_two_border_radius__hover_enabled=&#8221;off&#8221; button_two_border_radius__hover=&#8221;null&#8221; button_one_letter_spacing__hover_enabled=&#8221;off&#8221; button_one_letter_spacing__hover=&#8221;null&#8221; button_two_letter_spacing__hover_enabled=&#8221;off&#8221; button_two_letter_spacing__hover=&#8221;null&#8221; button_one_bg_color__hover_enabled=&#8221;off&#8221; button_one_bg_color__hover=&#8221;null&#8221; button_two_bg_color__hover_enabled=&#8221;off&#8221; button_two_bg_color__hover=&#8221;null&#8221;]<\/p>\n<p>Nuestro equipo ling\u00fc\u00edstico farmac\u00e9utico se especializa en traducci\u00f3n cl\u00ednica en m\u00e1s de 250\u00a0idiomas.<\/p>\n<p>[\/et_pb_fullwidth_header][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;3.20.2&#8243; custom_padding=&#8221;23px|0px|0|0px|false|false&#8221;][et_pb_row custom_padding=&#8221;0|0px|0|0px|false|false&#8221; _builder_version=&#8221;3.20.2&#8243;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;3.20.2&#8243;][divienhancer_breadcrumb _builder_version=&#8221;3.20.2&#8243;][\/divienhancer_breadcrumb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;3.20.2&#8243; background_color=&#8221;rgba(3,151,214,0.05)&#8221; custom_padding=&#8221;46px|0px|17px|0px|false|false&#8221;][et_pb_row custom_padding=&#8221;25px|0px|0|0px|false|false&#8221; _builder_version=&#8221;3.17.6&#8243;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;3.0.47&#8243;][et_pb_text _builder_version=&#8221;3.17.6&#8243;]<\/p>\n<h4>En\u00a0CSOFT, nuestros clientes nos suelen solicitar traducciones de una amplia gama de documentaci\u00f3n cl\u00ednica.<\/h4>\n<p>A continuaci\u00f3n, puede ver algunos ejemplos de la documentaci\u00f3n en la que nos especializamos:[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=&#8221;3.17.6&#8243;][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;3.0.47&#8243;][et_pb_text _builder_version=&#8221;3.17.6&#8243; text_font=&#8221;||||||||&#8221; header_font=&#8221;||||||||&#8221;]<\/p>\n<ul>\n<li>Fase 0 a IV<\/li>\n<li>Farmacolog\u00eda<\/li>\n<li>Toxicolog\u00eda<\/li>\n<li>Formularios de consentimiento informado (ICF)<\/li>\n<li>Formularios de informe de casos (CRF)<\/li>\n<li>Eventos y reacciones adversos (AE\/AR\/SAE\/SAR\/SUSAR)<\/li>\n<li>Reacciones adversas a los f\u00e1rmacos (ADR)<\/li>\n<li>Prospectos y etiquetas<\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;3.0.47&#8243;][et_pb_text _builder_version=&#8221;3.17.6&#8243;]<\/p>\n<ul>\n<li>Folletos de informaci\u00f3n<\/li>\n<li>Informes actualizados en materia de seguridad del desarrollo (DSUR)<\/li>\n<li>Comunicaci\u00f3n con una Junta de Revisi\u00f3n Institucional (IRB) o un Comit\u00e9 de \u00c9tica Independiente (IEC)<\/li>\n<li>Acuerdos de servicios cl\u00ednicos<\/li>\n<li>Protocolos y res\u00famenes de protocolos<\/li>\n<li>Manuales del investigador (IB)<\/li>\n<li>Informes de estudios cl\u00ednicos (CSR)<\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;3.0.47&#8243;][et_pb_text _builder_version=&#8221;3.17.6&#8243;]<\/p>\n<ul>\n<li>Documentaci\u00f3n cl\u00ednica destinada al paciente<\/li>\n<li>Hojas de informaci\u00f3n al paciente (HIP)<\/li>\n<li>Diarios del paciente<\/li>\n<li>Resumen de caracter\u00edsticas del producto (SmPC)<\/li>\n<li>Instrucciones de uso (IFU)<\/li>\n<li>Art\u00edculos cient\u00edficos<\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;3.17.6&#8243; custom_padding=&#8221;15px|0px|24px|0px|false|false&#8221;][et_pb_row _builder_version=&#8221;3.17.6&#8243;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;3.0.47&#8243;][et_pb_text _builder_version=&#8221;3.17.6&#8243;]<\/p>\n<h4 style=\"text-align: center;\">CSOFT\u00a0Health\u00a0Sciences garantiza la calidad de la traducci\u00f3n<\/h4>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row use_custom_gutter=&#8221;on&#8221; custom_padding=&#8221;0|0px|30px|0px|false|false&#8221; _builder_version=&#8221;3.17.6&#8243; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221;][et_pb_column type=&#8221;1_4&#8243; _builder_version=&#8221;3.0.47&#8243;][et_pb_blurb url=&#8221;\/medical-devices-translations\/&#8221; image=&#8221;https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2019\/10\/Scientific-Accuracy-icon-01.svg&#8221; alt=&#8221;devices&#8221; module_class=&#8221;blurb-6&#8243; _builder_version=&#8221;3.17.6&#8243; header_font=&#8221;|||on|||||&#8221; header_font_size=&#8221;15px&#8221; header_letter_spacing=&#8221;2px&#8221; body_text_color=&#8221;#333333&#8243; body_line_height=&#8221;1.6em&#8221; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; text_orientation=&#8221;center&#8221; child_filter_opacity=&#8221;86%&#8221; animation_style=&#8221;fade&#8221; animation_duration=&#8221;500ms&#8221; animation=&#8221;off&#8221; custom_css_blurb_image=&#8221;max-width: 98px;&#8221;]Precisi\u00f3n cient\u00edfica[\/et_pb_blurb][\/et_pb_column][et_pb_column type=&#8221;1_4&#8243; _builder_version=&#8221;3.0.47&#8243;][et_pb_blurb url=&#8221;\/pharmaceutical-translations\/&#8221; image=&#8221;https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2019\/10\/Cultural-Adaptions.svg&#8221; module_class=&#8221;blurb-6&#8243; _builder_version=&#8221;3.17.6&#8243; header_font=&#8221;|||on|||||&#8221; header_font_size=&#8221;15px&#8221; header_letter_spacing=&#8221;2px&#8221; body_text_color=&#8221;#333333&#8243; body_line_height=&#8221;1.6em&#8221; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; text_orientation=&#8221;center&#8221; child_filter_opacity=&#8221;86%&#8221; animation_style=&#8221;fade&#8221; animation_duration=&#8221;500ms&#8221; animation_delay=&#8221;100ms&#8221; animation=&#8221;off&#8221; custom_css_blurb_image=&#8221;max-width: 98px;&#8221;]Adaptaci\u00f3n cultural[\/et_pb_blurb][\/et_pb_column][et_pb_column type=&#8221;1_4&#8243; _builder_version=&#8221;3.0.47&#8243;][et_pb_blurb url=&#8221;\/?page_id=125398&#8243; image=&#8221;https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2019\/10\/Regulatory-Compliance-icon-3.svg&#8221; alt=&#8221;cro&#8221; module_class=&#8221;blurb-6&#8243; _builder_version=&#8221;3.17.6&#8243; header_font=&#8221;|||on|||||&#8221; header_font_size=&#8221;15px&#8221; header_letter_spacing=&#8221;2px&#8221; body_text_color=&#8221;#333333&#8243; body_line_height=&#8221;1.6em&#8221; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; text_orientation=&#8221;center&#8221; child_filter_opacity=&#8221;86%&#8221; animation_style=&#8221;fade&#8221; animation_duration=&#8221;500ms&#8221; animation_delay=&#8221;200ms&#8221; animation=&#8221;off&#8221; custom_css_blurb_image=&#8221;max-width: 98px;&#8221;]Cumplimiento regulatorio[\/et_pb_blurb][\/et_pb_column][et_pb_column type=&#8221;1_4&#8243; _builder_version=&#8221;3.0.47&#8243;][et_pb_blurb url=&#8221;\/?page_id=125384&#8243; image=&#8221;https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2019\/10\/Data-Security-and-Confidentiality-icon-4.svg&#8221; alt=&#8221;biotech&#8221; module_class=&#8221;blurb-6&#8243; _builder_version=&#8221;3.17.6&#8243; header_font=&#8221;|||on|||||&#8221; header_font_size=&#8221;15px&#8221; header_letter_spacing=&#8221;2px&#8221; body_text_color=&#8221;#333333&#8243; body_line_height=&#8221;1.6em&#8221; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221; text_orientation=&#8221;center&#8221; child_filter_opacity=&#8221;86%&#8221; animation_style=&#8221;fade&#8221; animation_duration=&#8221;500ms&#8221; animation_delay=&#8221;300ms&#8221; animation=&#8221;off&#8221; custom_css_blurb_image=&#8221;max-width: 98px;&#8221;]Seguridad y confidencialidad de los datos[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;3.17.6&#8243; background_image=&#8221;https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2019\/10\/Our-Methodology.jpg&#8221; parallax=&#8221;on&#8221; custom_padding=&#8221;12px|0px|0|0px|false|false&#8221;][et_pb_row custom_padding=&#8221;0|0px|25.5938px|0px|false|false&#8221; make_equal=&#8221;on&#8221; custom_css_main_1=&#8221;display: flex; || flex-direction: column; || justify-content: center;&#8221; custom_css_main_2=&#8221;display: flex; || flex-direction: column; || justify-content: center;&#8221; _builder_version=&#8221;3.0.83&#8243; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221;][et_pb_column type=&#8221;3_5&#8243; _builder_version=&#8221;3.0.47&#8243;][et_pb_text disabled_on=&#8221;on|on|off&#8221; _builder_version=&#8221;3.17.6&#8243; text_font_size=&#8221;20px&#8221; header_3_text_align=&#8221;left&#8221;]<\/p>\n<h4>Nuestra metodolog\u00eda<\/h4>\n<p>[\/et_pb_text][et_pb_text disabled_on=&#8221;on|on|off&#8221; _builder_version=&#8221;3.17.6&#8243; text_font=&#8221;||||||||&#8221; text_font_size=&#8221;16px&#8221; custom_margin=&#8221;||20px|&#8221;]CSOFT garantiza el empleo de metodolog\u00edas de traducci\u00f3n m\u00e9dica que cumplen con las normas jur\u00eddicas y reglamentarias, seg\u00fan los requisitos de nuestros clientes farmac\u00e9uticos.<\/p>\n<p>Nuestros traductores son nativos y expertos en materia, con conocimiento especializado en la traducci\u00f3n de contenido con requisitos espec\u00edficos. CSOFT asigna un equipo de traductores, editores y revisores m\u00e9dicos experimentados para ejecutar cada proyecto de traducci\u00f3n. Cada uno de los miembros de este equipo es responsable individualmente de la traducci\u00f3n, revisi\u00f3n, edici\u00f3n y revisi\u00f3n independiente.<\/p>\n<p>Gracias a nuestra larga trayectoria y amplia experiencia, nuestro equipo tiene la capacidad de personalizar los procesos operativos en base al an\u00e1lisis de los requisitos espec\u00edficos del proyecto. Siempre que es necesario, se implementan pasos adicionales de control de calidad, como traducci\u00f3n inversa, validaci\u00f3n ling\u00fc\u00edstica y certificaci\u00f3n.[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;2_5&#8243; _builder_version=&#8221;3.0.47&#8243;][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;3.17.6&#8243; background_color=&#8221;#ffffff&#8221; custom_padding=&#8221;3px|0px|21px|0px|false|false&#8221; global_module=&#8221;131039&#8243; saved_tabs=&#8221;all&#8221;][et_pb_row custom_padding=&#8221;23px|0px|0|0px|false|false&#8221; _builder_version=&#8221;3.0.48&#8243; background_size=&#8221;initial&#8221; background_position=&#8221;top_left&#8221; background_repeat=&#8221;repeat&#8221;][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;3.0.47&#8243;][et_pb_image src=&#8221;https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2019\/10\/Other-Medical-translation-Services-1.jpg&#8221; _builder_version=&#8221;3.17.6&#8243; max_width=&#8221;67%&#8221;][\/et_pb_image][\/et_pb_column][et_pb_column type=&#8221;1_2&#8243; _builder_version=&#8221;3.0.47&#8243;][et_pb_text disabled_on=&#8221;on|on|off&#8221; _builder_version=&#8221;3.17.6&#8243; text_font_size=&#8221;20px&#8221; header_3_text_align=&#8221;left&#8221;]<\/p>\n<h4>Otros servicios de traducci\u00f3n m\u00e9dica<\/h4>\n<p>[\/et_pb_text][et_pb_text disabled_on=&#8221;on|on|off&#8221; module_class=&#8221;check-list-box&#8221; _builder_version=&#8221;3.20.2&#8243; text_font=&#8221;||||||||&#8221; header_3_text_align=&#8221;center&#8221;]<\/p>\n<ul>\n<li>Estudios precl\u00ednicos y cl\u00ednicos<\/li>\n<li><a href=\"https:\/\/lifesciences.csoftintl.com\/es\/productos-sanitarios\/\">Productos sanitarios<\/a><\/li>\n<li><a href=\"https:\/\/lifesciences.csoftintl.com\/es\/aprendizaje-electronico\/\">Aprendizaje electr\u00f3nico<\/a><\/li>\n<li><a href=\"https:\/\/lifesciences.csoftintl.com\/es\/comunicacion-creativa\/\">Comunicaci\u00f3n creativa<\/a><\/li>\n<li><a href=\"https:\/\/lifesciences.csoftintl.com\/es\/validacion-linguistica\/\">Validaci\u00f3n ling\u00fc\u00edstica<\/a><\/li>\n<li><a href=\"https:\/\/lifesciences.csoftintl.com\/es\/gestion-terminologica\/?lang=es\">Gesti\u00f3n terminol\u00f3gica<\/a><\/li>\n<li><a title=\"Back Translation\" href=\"https:\/\/lifesciences.csoftintl.com\/es\/traduccion-inversa\/\">Traducci\u00f3n inversa<\/a><\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; 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