{"id":139927,"date":"2019-10-28T01:06:18","date_gmt":"2019-10-28T08:06:18","guid":{"rendered":"https:\/\/lifesciences.csoftintl.com\/linguistische-validierung\/"},"modified":"2023-01-26T15:05:47","modified_gmt":"2023-01-26T22:05:47","slug":"linguistische-validierung","status":"publish","type":"page","link":"https:\/\/lifesciences.csoftintl.com\/de\/linguistische-validierung\/","title":{"rendered":"Linguistische Validierung"},"content":{"rendered":"
[et_pb_section fb_built=”1″ fullwidth=”on” _builder_version=”3.22″ custom_margin=”|||” custom_padding=”0px|0px|0|0px|false|false”][et_pb_fullwidth_header button_one_text=”Treten Sie jetzt mit uns in Kontakt” button_one_url=”https:\/\/lifesciences.csoftintl.com\/de\/kontakt\/” background_overlay_color=”rgba(0,0,0,0.66)” content_max_width=”70%” content_max_width_tablet=”” content_max_width_phone=”” content_max_width_last_edited=”on|desktop” module_class=”hide-h1″ _builder_version=”4.5.3″ content_font_size=”22px” content_line_height=”1.9em” background_color=”rgba(255, 255, 255, 0)” background_image=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2019\/10\/Linguistic-Validation-banner.jpg” parallax=”on” parallax_method=”on” custom_button_two=”on” button_two_icon=”%%34%%” button_two_on_hover=”off” custom_margin=”|||” custom_padding=”40px||80px|” custom_padding_tablet=”” custom_padding_phone=”50px||50px|” custom_padding_last_edited=”on|desktop” content_font_size_tablet=”” content_font_size_phone=”17px” content_font_size_last_edited=”on|desktop” button_one_text_size__hover_enabled=”off” button_one_text_size__hover=”null” button_two_text_size__hover_enabled=”off” button_two_text_size__hover=”null” button_one_text_color__hover_enabled=”off” button_one_text_color__hover=”null” button_two_text_color__hover_enabled=”off” button_two_text_color__hover=”null” button_one_border_width__hover_enabled=”off” button_one_border_width__hover=”null” button_two_border_width__hover_enabled=”off” button_two_border_width__hover=”null” button_one_border_color__hover_enabled=”off” button_one_border_color__hover=”null” button_two_border_color__hover_enabled=”off” button_two_border_color__hover=”null” button_one_border_radius__hover_enabled=”off” button_one_border_radius__hover=”null” button_two_border_radius__hover_enabled=”off” button_two_border_radius__hover=”null” button_one_letter_spacing__hover_enabled=”off” button_one_letter_spacing__hover=”null” button_two_letter_spacing__hover_enabled=”off” button_two_letter_spacing__hover=”null” button_one_bg_color__hover_enabled=”off” button_one_bg_color__hover=”null” button_two_bg_color__hover_enabled=”off” button_two_bg_color__hover=”null”]<\/p>\n
We provide the highest-quality linguistic validation and validated translation services for pharmaceutical companies and CROs involved in clinical research.[\/et_pb_fullwidth_header][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.22″ custom_padding=”23px|0px|0|0px|false|false”][et_pb_row _builder_version=”3.25″ custom_padding=”0|0px|0|0px|false|false”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][divienhancer_breadcrumb _builder_version=”3.20.2″][\/divienhancer_breadcrumb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.22″ custom_padding=”0|0px|0|0px|false|false”][et_pb_row _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”60px|0px|60px|0px”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text disabled_on=”off|off|off” _builder_version=”4.5.3″ text_font_size=”20px” header_3_text_align=”center” custom_padding=”0px||0px|”]<\/p>\n
Effective linguistic validation services are essential to ensuring the quality and validity of translated clinical outcome assessments\u00a0(COAs), as well as\u00a0multilingual international clinical trials<\/u><\/a>. Accurate medical translations are a mandatory regulatory compliance requirement for international clinical research and development.<\/p>\n Linguistic validation is a complicated undertaking involving medical\u00a0terminology management<\/u><\/a>, forward translation, linguistic harmonization,\u00a0back translation<\/u><\/a>, and language reconciliation by professional life science linguists and subject matter experts\u00a0(SMEs)\u00a0such as doctors and clinicians.<\/p>\n CSOFT\u2019s medical linguists and subject matter experts like doctors, clinicians, and healthcare professionals are dedicated to delivering linguistic validation services for the best possible ROI.<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.22″ background_color=”#f9f9f9″ custom_padding=”20px|0px|60px|0px|false|false”][et_pb_row column_structure=”1_3,2_3″ _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”40px|0px|0px|0px”][et_pb_column type=”1_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_image src=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2020\/10\/tools-we-use-4.png” alt=”Linguistic validation requires multilingual subject matter expertise” align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”4.5.3″ max_width=”76%” module_alignment=”center” custom_padding=”50px||”][\/et_pb_image][\/et_pb_column][et_pb_column type=”2_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text disabled_on=”off|off|off” _builder_version=”4.5.3″ text_font_size=”20px” header_3_text_align=”center” custom_padding=”0px||0px|”]<\/p>\n CSOFT brings years of experience to our medical translation services across the life science industries, from\u00a0pharmaceutical<\/u><\/a><\/span>s,\u00a0clinical research<\/u><\/a><\/span>, biotech<\/u><\/a><\/span>\u00a0and medical device<\/u><\/a><\/span>\u00a0manufacturing. We employ professional in-country linguists and life science subject matter experts to deliver linguistically accurate and technically precise clinical translations with an emphasis on\u00a0medical\u00a0localization performance. As an\u00a0ISO 9001:2015, ISO 17100:2015, and ISO 13485:2016 certified<\/u><\/a><\/span>\u00a0company, CSOFT has the tools, knowledge, and experience to deliver the top-notch linguistic validation services\u00a0that\u00a0our clients depend on for global success.<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.22″ custom_padding=”0|0px|0|0px|false|false”][et_pb_row column_structure=”2_3,1_3″ _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”60px|0px|60px|0px”][et_pb_column type=”2_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text disabled_on=”off|off|off” _builder_version=”4.5.3″ text_font_size=”20px” header_3_text_align=”center” custom_padding=”0px||0px|”]<\/p>\n Clinical trials<\/u><\/a><\/span>\u00a0are increasingly conducted internationally, with patients, investigators, trial organizers, and even doctors and clinicians who all speak different languages. As a result, many of the clinical studies, research reports, trial sponsor materials, and patient documents such as\u00a0ICFs (informed consent forms)<\/u><\/a><\/span>, PROs (patient reported outcomes), and patient questionnaires\u00a0<\/u><\/a><\/span>must be accurately translated and validated.<\/p>\n Multilingual clinical trials serve several purposes: better patient sampling to cover different ethnic groups; spending reductions with lower labor cost in overseas markets; and enhanced international market entry once the drugs are approved by regulatory authorities such as the FDA,\u00a0NMPA<\/u><\/a><\/span>, and EMA.<\/p>\n Learn more<\/u><\/a><\/span>\u00a0about our multilingual clinical trial solutions.<\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_image src=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2020\/09\/chemical-3.png” alt=”Linguistic validation impacts biomedical research across fields and focus areas” align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”4.5.3″ max_width=”64%” module_alignment=”center” custom_padding=”50px||”][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ module_class=”white” _builder_version=”3.22″ background_color=”#fafafa” background_image=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2020\/12\/dna-bg1.jpg” custom_padding=”0|0px|0|0px|false|false”][et_pb_row column_structure=”1_5,3_5,1_5″ _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”60px|0px|60px|0px”][et_pb_column type=”1_5″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][\/et_pb_column][et_pb_column type=”3_5″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text disabled_on=”off|off|off” module_class=”yellowlink” _builder_version=”4.5.3″ text_font=”||||||||” text_text_color=”#ffffff” text_font_size=”20px” header_font=”||||||||” header_2_font=”||||||||” header_2_text_color=”#ffffff” header_3_text_align=”center” text_orientation=”center” custom_padding=”0px||0px|”]<\/p>\n Clinical outcome assessments (COAs) are a fundamental component of the clinical trial lifecycle. COAs document the benefits and risks of a treatment reported by the patient, clinicians, or trial observers within a given\u00a0clinical trial<\/u><\/a><\/span>. Learn more<\/u><\/a><\/span>\u00a0about our clinical outcome assessment (COA) translations.<\/p>\n <\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_5″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.22″ custom_padding=”0|0px|0|0px|false|false”][et_pb_row column_structure=”1_3,2_3″ _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”60px|0px|60px|0px”][et_pb_column type=”1_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_image src=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2020\/10\/pharmaceuticals.png” alt=”Accuracy is an absolute requirement in linguistic validation ” align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”4.5.3″ max_width=”71%” module_alignment=”center”][\/et_pb_image][\/et_pb_column][et_pb_column type=”2_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text disabled_on=”off|off|off” _builder_version=”4.5.3″ text_font_size=”20px” header_3_text_align=”center” custom_padding=”0px||0px|”]<\/p>\n Within the life science industry, patient-centered\u00a0clinical solutions<\/u><\/a><\/span>\u00a0and treatment systems are rapidly gaining momentum. There is a growing trend in modern clinical trials to give importance to patient opinions, comments, and complaints\u2013 namely, patient-reported outcomes (PROs), as opposed to reports from clinicians, caregivers, and trial observers.<\/p>\n This trend makes it even more important to accurately translate and linguistically validate PROs in order to effectively obtain drug approvals from regulatory authorities in international markets. CSOFT\u00a0Health Sciences\u2019 linguistic subject matter experts and localization best practices ensure both efficient and\u00a0high-quality<\/u><\/a><\/span>\u00a0linguistic validation for all your patient reported outcomes, in over 250 languages.<\/p>\n Learn more<\/u><\/a><\/span>\u00a0<\/u>about our PRO translations.<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.22″ background_color=”#fafafa” custom_padding=”0|0px|60px|0px|false|false”][et_pb_row column_structure=”3_5,2_5″ _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”40px|0px|0px|0px”][et_pb_column type=”3_5″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text disabled_on=”off|off|off” _builder_version=”4.5.3″ text_font_size=”20px” header_3_text_align=”center” custom_padding=”0px||0px|” hover_enabled=”0″]<\/p>\n A clinician-reported outcome (ClinRO) assessment is designed to measure the status of patients\u2019 health and define end-point treatments and the\u00a0benefits of medical interventions for patients such as their physical feel, function, or survival in\u00a0clinical trials<\/u><\/a>. These assessments must be accurately translated through qualified linguistic validation processes to ensure regulatory compliance and the eventual approval of the related drugs or drug therapy.<\/p>\n When pharmaceutical companies and CROs invest millions of dollars to conduct clinical studies, top-quality translation is crucial to delivering these clinician-reported outcome assessment documents. CSOFT Health Sciences is a language industry leader in professional linguistic validation for a variety of COA assessments including Clinician-Reported Outcomes (ClinRO), Observer-Reported Outcomes (ObsRo), and Performance-Outcomes (PerfO).<\/p>\n Learn more<\/a> about our ClinRO translations. <\/u><\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”2_5″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_image src=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2020\/11\/patient.png” align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”3.23″ max_width=”64%” module_alignment=”center” custom_padding=”30px||”][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.5.3″ background_enable_color=”off” custom_padding=”0|0px|60px|0px|false|false”][et_pb_row _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”40px|0px|0px|0px”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text disabled_on=”off|off|off” _builder_version=”4.5.3″ text_font_size=”20px” header_3_text_align=”center” custom_padding=”0px||0px|” hover_enabled=”0″]<\/p>\n A\u00a0Trial Master Files\u00a0(TMF) is\u00a0an important collection of documents submitted to regulatory agencies during clinical trials to demonstrate\u00a0that\u00a0a trial adheres to the approved\u00a0clinical trial\u00a0protocol and Good Clinical Practice (GCP). TMFs also serve to protect patient data and contain a number of essential documents, including informed consent forms, investigator brochures, site information, and more. Ensuring that these files are translated to the highest degree of accuracy with\u00a0linguistic validation is an important way to meet\u00a0global\u00a0regulatory requirements. With a large percentage of clinical trials being conducted in overseas markets with different language requirements, relying on the support of a trusted language service provider (LSP)\u00a0can be crucial to a smooth regulatory approval\u00a0process. CSOFT Health Sciences provides cost-effective and timely translations for all types of clinical trial documents to include TMFs.<\/p>\n Learn more<\/u><\/a>\u00a0about our linguistic validation for Trial Master File (TMF)\u00a0translations.<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.5.3″ background_color=”#f9f9f9″ custom_padding=”0|0px|60px|0px|false|false”][et_pb_row column_structure=”3_5,2_5″ _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”40px|0px|0px|0px”][et_pb_column type=”3_5″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text disabled_on=”off|off|off” _builder_version=”4.5.3″ text_font_size=”20px” header_3_text_align=”center” custom_padding=”0px||0px|”]<\/p>\n Cognitive debriefing is an important step in the linguistic validation process, where a\u00a0research tool\u00a0or\u00a0patient questionnaire, like a patient reported outcome (PRO),\u00a0is tested on\u00a0a small group of members of the target\u00a0patient population\u00a0to\u00a0ensure\u00a0that\u00a0on a conceptual level, the\u00a0respondents understand the translated questionnaire\u00a0content as the\u00a0same as the original.\u00a0This step is crucial\u00a0to\u00a0the linguistic validation process\u00a0as any misunderstanding\u00a0or confusion\u00a0in the interpretation of the questions could\u00a0result in regulatory rejection or\u00a0worse, endanger patients\u2019 lives\u00a0as they lack the fundamental understanding of their treatment.<\/p>\n Learn more about CSOFT\u2019s Cognitive Debriefing Services<\/u><\/a>[\/et_pb_text][\/et_pb_column][et_pb_column type=”2_5″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_image src=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2022\/03\/psyhicatry-translations-1.svg” title_text=”psyhicatry-translations-1″ align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”4.5.3″ max_width=”64%” module_alignment=”center” custom_padding=”30px||”][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ module_class=”bg-blue-dark” _builder_version=”4.5.3″ background_enable_color=”off” custom_padding=”0|0px|60px|0px|false|false”][et_pb_row _builder_version=”4.5.3″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”60px|0px|0px|0px|false|false”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text disabled_on=”off|off|off” _builder_version=”4.5.3″ text_font_size=”20px” header_2_text_color=”#ffffff” header_3_text_align=”center” custom_padding=”0px||0px|”]<\/p>\n Case report forms (CRFs) refer to a questionnaire that is commonly used in clinical trials by sponsors to collect patient information and data. For multinational clinical trials, translations for CRFs may be a regulatory requirement and enable sponsors to collect more accurate information on patients with diverse linguistic and cultural backgrounds. Ensuring that CRFs are correctly translated with\u00a0linguistic validation can be a necessary strategy for meeting strict regulatory standards on language and ensuring this document can be understood by the targeted population. CSOFT Health Sciences supports sponsors with highly accurate translations and end-to-end localization solutions for all manner of documents needed during the clinical trial process.<\/p>\n Learn more<\/u><\/a><\/span>\u00a0about our\u00a0linguistic validation for\u00a0case report form (CRF) translations.<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.5.3″ background_color=”#f9f9f9″ custom_padding=”0|0px|60px|0px|false|false”][et_pb_row column_structure=”2_3,1_3″ _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”40px|0px|0px|0px”][et_pb_column type=”2_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text disabled_on=”off|off|off” _builder_version=”4.5.3″ text_font_size=”20px” header_3_text_align=”center” custom_padding=”0px||0px|” hover_enabled=”0″]<\/p>\n Clinical trial protocols are a crucial document that aims to describe the objective, study design, safety measures, organization, and other important aspects of how the trial will be conducted. For anyone conducting clinical trials overseas and in compliance with global regulatory standards, ensuring the highest quality translation for clinical trial protocols with linguistic validation may be a necessary step to gain approval. CSOFT Health Sciences specializes in technical translations for a wide range of clinical trial documents and our team of subject matter experts and in-country linguists ensure that translations are done in a professional and timely manner.<\/p>\n Learn more<\/u><\/a>\u00a0about our linguistic validation for clinical trial protocol translations.<\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_image src=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2020\/05\/ClinicalTrials01.png” title_text=”ClinicalTrials01″ align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”4.5.3″ max_width=”64%” module_alignment=”center” custom_padding=”30px||”][\/et_pb_image][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.22″ custom_padding=”0|0px|0|0px|false|false”][et_pb_row _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”40px|0px|0px|0px”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text disabled_on=”off|off|off” _builder_version=”4.5.3″ text_font=”||||||||” text_font_size=”20px” header_3_text_align=”center” text_orientation=”center” custom_padding=”0px||0px|” hover_enabled=”0″]<\/p>\n Quality linguistic validation services must be performed by professional linguists working together with medical subject matter experts such as physicians, clinicians, and pharmaceutical specialists to produce optimal output that meets\u00a0regulatory compliance<\/u><\/a>\u00a0requirements.<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.22″ custom_padding=”0|0px|0|0px|false|false”][et_pb_row _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”40px|0px|0px|0px”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text disabled_on=”off|off|off” _builder_version=”4.5.3″ text_font_size=”20px” header_3_text_align=”center” custom_padding=”0px|50px|0px|” hover_enabled=”0″]<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_4,1_4,1_4,1_4″ _builder_version=”3.25″][et_pb_column type=”1_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text module_class=”ul-list-two” _builder_version=”4.5.3″ hover_enabled=”0″]<\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text module_class=”ul-list-two” _builder_version=”4.5.3″]<\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.5.3″]<\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.5.3″]<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.22″ background_color=”#ffffff” custom_padding=”0|0px|21px|0px|false|false”][et_pb_row _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”0|0px|25.5938px|0px|false|false”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text disabled_on=”on|on|off” _builder_version=”4.5.3″ text_font=”||||||||” text_font_size=”20px” header_3_text_align=”center” text_orientation=”center” custom_padding=”||40px|” hover_enabled=”0″]Our linguistic validation team experience in the following areas and many others:<\/strong>[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_4,1_4,1_4,1_4″ use_custom_gutter=”on” _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”0|0px|30px|0px|false|false”][et_pb_column type=”1_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_blurb image=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2019\/10\/PRO-Questionnaires-icon-01.svg” alt=”Ger\u00e4te” module_class=”blurb-6″ _builder_version=”4.5.3″ header_font=”|||on|||||” header_font_size=”15px” header_letter_spacing=”2px” body_text_color=”#333333″ body_line_height=”1.6em” background_size=”initial” background_position=”top_left” background_repeat=”repeat” text_orientation=”center” child_filter_opacity=”86%” animation_style=”fade” animation_duration=”500ms” animation=”off” hover_enabled=”0″ custom_css_blurb_image=”max-width: 98px;”]PRO-Frageb\u00f6gen[\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_blurb image=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2019\/10\/ClinRO-Questionnaires-icon-02.svg” module_class=”blurb-6″ _builder_version=”3.20.2″ header_font=”|||on|||||” header_font_size=”15px” header_letter_spacing=”2px” body_text_color=”#333333″ body_line_height=”1.6em” background_size=”initial” background_position=”top_left” background_repeat=”repeat” text_orientation=”center” child_filter_opacity=”86%” animation_style=”fade” animation_duration=”500ms” animation_delay=”100ms” animation=”off” custom_css_blurb_image=”max-width: 98px;”]ClinRO-Frageb\u00f6gen[\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_blurb image=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2019\/10\/ePROs-icon-03.svg” alt=”cro” module_class=”blurb-6″ _builder_version=”3.20.2″ header_font=”|||on|||||” header_font_size=”15px” header_letter_spacing=”2px” body_text_color=”#333333″ body_line_height=”1.6em” background_size=”initial” background_position=”top_left” background_repeat=”repeat” text_orientation=”center” child_filter_opacity=”86%” animation_style=”fade” animation_duration=”500ms” animation_delay=”200ms” animation=”off” custom_css_blurb_image=”max-width: 98px;”]eCOAs\/ePROs[\/et_pb_blurb][\/et_pb_column][et_pb_column type=”1_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_blurb image=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2019\/10\/Patient-Diaries-icon-0.svg” alt=”Biotech” module_class=”blurb-6″ _builder_version=”3.20.2″ header_font=”|||on|||||” header_font_size=”15px” header_letter_spacing=”2px” body_text_color=”#333333″ body_line_height=”1.6em” background_size=”initial” background_position=”top_left” background_repeat=”repeat” text_orientation=”center” child_filter_opacity=”86%” animation_style=”fade” animation_duration=”500ms” animation_delay=”300ms” animation=”off” custom_css_blurb_image=”max-width: 98px;”]Patiententageb\u00fccher[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.22″ background_image=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2019\/10\/Linguistic-Validation-1.jpg” parallax=”on” custom_padding=”51.1875px|0px|0|0px|false|false”][et_pb_row column_structure=”1_2,1_2″ make_equal=”on” _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”25.5938px|0px|0|0px|false|false”][et_pb_column type=”1_2″ _builder_version=”3.25″ custom_padding=”|||” custom_css_main_element=”display: flex; || flex-direction: column; || justify-content: center;” custom_padding__hover=”|||”][et_pb_text disabled_on=”on|on|off” _builder_version=”4.5.3″ header_3_text_align=”left” custom_margin=”||30px|” custom_padding=”||0px||false|false” hover_enabled=”0″]<\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”3.25″ custom_padding=”|||” custom_css_main_element=”display: flex; || flex-direction: column; || justify-content: center;” custom_padding__hover=”|||”][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”3_4,1_4″ module_class=”linguistic-ul” _builder_version=”4.5.3″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”0px||||false|false”][et_pb_column type=”3_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text disabled_on=”on|on|off” module_class=”number-list” _builder_version=”4.5.3″ text_font=”||||||||” text_font_size=”16px” custom_margin=”||20px|” hover_enabled=”0″]<\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.5.3″][\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”3.20.2″ background_color=”#ffffff” custom_padding=”60px|0px|60px|0px|false|false” global_module=”131039″ saved_tabs=”all”][et_pb_row _builder_version=”4.5.3″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”0px|0px|40px|0px|false|false”][et_pb_column type=”4_4″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text disabled_on=”off|off|off” _builder_version=”4.5.3″ text_font_size=”20px” header_3_text_align=”left”]<\/p>\n Our end-to-end medical translation and localization services coverage extends across a range of clients, medical professionals, and treatment settings. In addition\u00a0to CSOFT Health Sciences\u2019 cost effective and timely terminology management solutions for life science companies, our global network of in-country linguists and subject matter experts specialize in a wide range of localization solutions for medical content, including:<\/p>\n [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”2_5,3_5″ _builder_version=”3.25″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”0px|0px|0|0px|false|false”][et_pb_column type=”2_5″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_image src=”https:\/\/lifesciences.csoftintl.com\/wp-content\/uploads\/2019\/10\/Other-Medical-translation-Services-1.jpg” alt=”Back Translation and Terminology Management” title_text=”Back Translation and Terminology Management” align_tablet=”center” align_phone=”” align_last_edited=”on|desktop” _builder_version=”4.5.3″ width=”78%” max_width=”100%” module_alignment=”center” custom_padding=”50px||” locked=”off”][\/et_pb_image][\/et_pb_column][et_pb_column type=”3_5″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text disabled_on=”off|off|off” module_class=”check-list-box” _builder_version=”4.5.3″ text_font=”||||||||” header_3_text_align=”center”]<\/p>\n Learn more<\/u><\/a><\/span>\u00a0about our full range of medical translation solutions.[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.5.3″ background_enable_color=”off” custom_padding=”0|0px|0px|0px|false|false” locked=”off”][et_pb_row column_structure=”2_3,1_3″ _builder_version=”4.5.3″ background_size=”initial” background_position=”top_left” background_repeat=”repeat” custom_padding=”60px|0px|60px|0px” border_width_top=”1px” border_color_top=”#cccccc” global_module=”175789″ saved_tabs=”all”][et_pb_column type=”2_3″ _builder_version=”3.25″ custom_padding=”|||” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.5.3″ _module_preset=”default”]\n\n\n \nCSOFT Health Sciences has\u00a0developed a process for quality assurance to ensure that every medical translation\u00a0project meets quality standards in a cost-effective and timely manner. We are certified in\u00a0ISO 17100:2015<\/b><\/strong>,\u00a0ISO 9001:2015<\/b><\/strong>, and\u00a0ISO 13485:2016<\/b><\/strong>\u00a0<\/b><\/strong>to ensure our customized solutions meet global regulatory requirements. Our\u00a0subject matter expert linguists have a minimum of 7 years\u2019 experience and work with in-country reviewers and project style guides to meet industry standards.\u00a0And\u00a0through our\u00a0innovative cloud-based technology<\/u><\/a><\/span>, CSOFT offers an online translation management ecosystem for one central location to leverage both translation memory as well as terminology management in real time.\u00a0Every step of the way, CSOFT has you covered.\n\n<\/p>\nProven Linguistic Validation Expertise<\/h2>\n
Linguistic Validation for Clinical Trials<\/h2>\n
Linguistic Validation for COAs<\/h2>\n
For multilingual clinical trials, COAs conducted in other languages must be accurately translated and validated through a rigorous linguistic validation process. CSOFT\u00a0Health Sciences\u2019\u00a0global network of translators offers linguistic and in-field experience to help the world\u2019s leading\u00a0pharmaceutical<\/u><\/a><\/span>\u00a0and\u00a0CRO companies<\/u><\/a><\/span>\u00a0confidently conduct COA linguistic validation.<\/p>\nTranslating Patient-Reported Outcomes (PRO)<\/h2>\n
Linguistic Validation for Clinician-Reported Outcomes (ClinRo)<\/h2>\n
Linguistic Validation for Trial Master Files (TMF)<\/h2>\n
Cognitive Debriefing<\/h2>\n
Linguistic Validation for\u00a0Case Report Forms (CRFs)<\/h2>\n
Clinical Trial Protocol Validation<\/h2>\n
Linguistic Validation with Medical Experts<\/h2>\n
Our linguistic validation team experience in the following areas and many others:<\/h3>\n
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Our Methodology<\/h2>\n
Our linguistic validation team experience in the following areas and many others:<\/h3>\n
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Other Medical Translation Services<\/h2>\n
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Quality Assurance<\/h2>\n