{"id":29,"date":"2022-11-29T08:59:06","date_gmt":"2022-11-29T08:59:06","guid":{"rendered":"https:\/\/www.dcberne.com\/?page_id=29"},"modified":"2024-10-12T09:59:45","modified_gmt":"2024-10-12T09:59:45","slug":"offering","status":"publish","type":"page","link":"https:\/\/www.dcberne.com\/en\/offering\/","title":{"rendered":"Services"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; disabled_on=&#8221;off|off|off&#8221; _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; background_color=&#8221;#E1E3E8&#8243; height=&#8221;714px&#8221; height_tablet=&#8221;auto&#8221; height_phone=&#8221;auto&#8221; height_last_edited=&#8221;on|tablet&#8221; custom_margin=&#8221;0px||0px||false|false&#8221; custom_margin_tablet=&#8221;0px||0px||false|false&#8221; custom_margin_phone=&#8221;3px||||false|false&#8221; custom_margin_last_edited=&#8221;on|phone&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; background_color_tablet=&#8221;#FAFAFA&#8221; background_color_phone=&#8221;#FAFAFA&#8221; background_last_edited=&#8221;off|desktop&#8221; background_enable_color_tablet=&#8221;on&#8221; background_enable_color_phone=&#8221;on&#8221; background_enable_video_mp4_tablet=&#8221;off&#8221; border_radii=&#8221;off|200px||200px|&#8221; border_radii_tablet=&#8221;off|140px||140px|&#8221; border_radii_phone=&#8221;off|80px||80px|&#8221; border_radii_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row column_structure=&#8221;1_2,1_2&#8243; disabled_on=&#8221;off|off|off&#8221; _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; custom_margin=&#8221;0px||0px||false|false&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; custom_css_main_element=&#8221;height: 100%;||display: flex;||justify-content: center;&#8221; global_colors_info=&#8221;{}&#8221; custom_css_main_element_last_edited=&#8221;on|desktop&#8221; custom_css_main_element_tablet=&#8221;display: flex;||flex-direction: column;&#8221; custom_css_main_element_phone=&#8221;display: flex;||flex-direction: column;&#8221;][et_pb_column type=&#8221;1_2&#8243; disabled_on=&#8221;off|off|off&#8221; _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;||0px||false|false&#8221; custom_css_main_element=&#8221;display: flex;||flex-direction: column;||justify-content: center;||margin-bottom: 0px;&#8221; global_colors_info=&#8221;{}&#8221; custom_css_main_element_last_edited=&#8221;off|desktop&#8221; custom_css_main_element_tablet=&#8221;display: flex;||flex-direction: column;||justify-content: center;&#8221; custom_css_main_element_phone=&#8221;display: flex;||flex-direction: column;||justify-content: center;&#8221;][et_pb_text _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;Avant Regular||||||||&#8221; text_text_color=&#8221;#000000&#8243; text_font_size=&#8221;64px&#8221; text_line_height=&#8221;70px&#8221; custom_margin=&#8221;0px||8px||false|false&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; custom_padding_tablet=&#8221;80px||0px||false|false&#8221; custom_padding_phone=&#8221;65px||||false|false&#8221; custom_padding_last_edited=&#8221;on|phone&#8221; text_font_size_tablet=&#8221;64px&#8221; text_font_size_phone=&#8221;42px&#8221; text_font_size_last_edited=&#8221;on|phone&#8221; text_line_height_tablet=&#8221;70px&#8221; text_line_height_phone=&#8221;48px&#8221; text_line_height_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>Our services<\/p>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;Avant Regular||||||||&#8221; text_text_color=&#8221;#505358&#8243; text_font_size=&#8221;16px&#8221; text_line_height=&#8221;24px&#8221; custom_padding=&#8221;||0px||false|false&#8221; custom_padding_tablet=&#8221;||80px||false|false&#8221; custom_padding_phone=&#8221;||65px||false|false&#8221; custom_padding_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p><span>DCB supports (patient) entrepreneurs, researchers and bigger corporates on their way towards market entry. Our specialised teams offer access to an international pool of experts, individual coaching sessions, clinical research and (pre-)seed funding. 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Choose the services that will bring you and your project forward in the coming weeks and months and exchange ideas with our diabetes tech experts.<\/p>\n<p>[\/et_pb_text][et_pb_button button_url=&#8221;https:\/\/www.google.com&#8221; button_text=&#8221;Button text&#8221; disabled_on=&#8221;on|on|on&#8221; _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; custom_button=&#8221;on&#8221; button_text_size=&#8221;18px&#8221; button_text_color=&#8221;#89bbe5&#8243; button_border_width=&#8221;1px&#8221; button_border_color=&#8221;#89bbe5&#8243; button_border_radius=&#8221;100px&#8221; button_font=&#8221;Calibro Bold||||||||&#8221; button_use_icon=&#8221;off&#8221; custom_margin=&#8221;32px||0px||false|false&#8221; custom_padding=&#8221;10px|64px|8px|64px|false|false&#8221; disabled=&#8221;on&#8221; global_colors_info=&#8221;{}&#8221; button_text_size__hover_enabled=&#8221;off|hover&#8221; button_text_size__hover=&#8221;14px&#8221; button_text_color__hover_enabled=&#8221;on|hover&#8221; 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Do you need a clinical validation of your medical device? Would you like feedback on the study design, or are you looking for cooperation partners and specialists for a grant application?<\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.19.1&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_toggle title=&#8221;Pre-study&#8221; open_toggle_text_color=&#8221;#000000&#8243; open_toggle_background_color=&#8221;RGBA(255,255,255,0)&#8221; closed_toggle_text_color=&#8221;#000000&#8243; closed_toggle_background_color=&#8221;RGBA(255,255,255,0)&#8221; icon_color=&#8221;#000000&#8243; toggle_icon=&#8221;&#x33;||divi||400&#8243; open_icon_color=&#8221;#89bbe5&#8243; open_toggle_icon=&#8221;&#x32;||divi||400&#8243; _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; title_text_color=&#8221;#000000&#8243; title_font=&#8221;Avant Regular||||||||&#8221; title_font_size=&#8221;16px&#8221; title_line_height=&#8221;26px&#8221; closed_title_font=&#8221;Avant Regular||||||||&#8221; 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open_toggle_text_color=&#8221;#000000&#8243; open_toggle_background_color=&#8221;RGBA(255,255,255,0)&#8221; closed_toggle_text_color=&#8221;#000000&#8243; closed_toggle_background_color=&#8221;RGBA(255,255,255,0)&#8221; icon_color=&#8221;#000000&#8243; toggle_icon=&#8221;&#x33;||divi||400&#8243; open_icon_color=&#8221;#89bbe5&#8243; open_toggle_icon=&#8221;&#x32;||divi||400&#8243; _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; title_text_color=&#8221;#000000&#8243; title_font=&#8221;Avant Regular||||||||&#8221; title_font_size=&#8221;16px&#8221; title_line_height=&#8221;26px&#8221; closed_title_font=&#8221;Avant Regular||||||||&#8221; closed_title_line_height=&#8221;26px&#8221; body_font=&#8221;Calibri Regular||||||||&#8221; body_text_color=&#8221;#000000&#8243; body_font_size=&#8221;12px&#8221; body_line_height=&#8221;18px&#8221; custom_margin=&#8221;0px||0px||false|false&#8221; custom_padding=&#8221;10px|0px|10px|0px|false|false&#8221; border_width_all=&#8221;0px&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<div class=\"ewa-rteLine\">On-site monitoring<\/div>\n<div class=\"ewa-rteLine\">Central data monitoring<\/div>\n<div class=\"ewa-rteLine\">Safety: AE\/ADE and SAE\/SADE reporting, Device deficiency reporting<\/div>\n<div class=\"ewa-rteLine\">Site management<\/div>\n<div class=\"ewa-rteLine\">Preparation of amendment(s)<\/div>\n<div class=\"ewa-rteLine\">Submission of changes during study conduct (AM, new site, PI changes, safety reporting\u2026)<\/div>\n<div class=\"ewa-rteLine\">(e)TMF maintenance<\/div>\n<div class=\"ewa-rteLine\">Deviation management<\/div>\n<div class=\"ewa-rteLine\">Interim analysis (constitution of IDMC)<\/div>\n<div class=\"ewa-rteLine\">Investigator meetings<\/div>\n<div class=\"ewa-rteLine\">Medical device supply<\/div>\n<div class=\"ewa-rteLine\">Support in case of site audit<\/div>\n<div class=\"ewa-rteLine\">Risk management (monitoring of mitigation strategy, update in case of AM)<\/div>\n<p>[\/et_pb_toggle][et_pb_toggle title=&#8221;Post study&#8221; open_toggle_text_color=&#8221;#000000&#8243; open_toggle_background_color=&#8221;RGBA(255,255,255,0)&#8221; closed_toggle_text_color=&#8221;#000000&#8243; closed_toggle_background_color=&#8221;RGBA(255,255,255,0)&#8221; icon_color=&#8221;#000000&#8243; toggle_icon=&#8221;&#x33;||divi||400&#8243; open_icon_color=&#8221;#89bbe5&#8243; open_toggle_icon=&#8221;&#x32;||divi||400&#8243; _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; title_text_color=&#8221;#000000&#8243; title_font=&#8221;Avant Regular||||||||&#8221; title_font_size=&#8221;16px&#8221; title_line_height=&#8221;26px&#8221; closed_title_font=&#8221;Avant Regular||||||||&#8221; closed_title_line_height=&#8221;26px&#8221; body_font=&#8221;Calibri Regular||||||||&#8221; body_text_color=&#8221;#000000&#8243; body_font_size=&#8221;12px&#8221; body_line_height=&#8221;18px&#8221; custom_margin=&#8221;0px||0px||false|false&#8221; custom_padding=&#8221;10px|0px|10px|0px|false|false&#8221; border_width_all=&#8221;0px&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<div class=\"ewa-rteLine\">Monitoring (close-down)<\/div>\n<div class=\"ewa-rteLine\">Database lock<\/div>\n<div class=\"ewa-rteLine\">Data management and data validation<\/div>\n<div class=\"ewa-rteLine\">Data preparation<\/div>\n<div class=\"ewa-rteLine\">Statistical analysis, contribution to final report<\/div>\n<div class=\"ewa-rteLine\">Submission final study report, notification of study termination<\/div>\n<div class=\"ewa-rteLine\">Support for publication writing, submission to journals<\/div>\n<div class=\"ewa-rteLine\">Anonymization of dataset<\/div>\n<div class=\"ewa-rteLine\">Archiving<\/div>\n<p>[\/et_pb_toggle][et_pb_toggle title=&#8221;Grant submission&#8221; open_toggle_text_color=&#8221;#000000&#8243; open_toggle_background_color=&#8221;RGBA(255,255,255,0)&#8221; closed_toggle_text_color=&#8221;#000000&#8243; closed_toggle_background_color=&#8221;RGBA(255,255,255,0)&#8221; icon_color=&#8221;#000000&#8243; toggle_icon=&#8221;&#x33;||divi||400&#8243; open_icon_color=&#8221;#89bbe5&#8243; open_toggle_icon=&#8221;&#x32;||divi||400&#8243; _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; title_text_color=&#8221;#000000&#8243; title_font=&#8221;Avant Regular||||||||&#8221; title_font_size=&#8221;16px&#8221; title_line_height=&#8221;26px&#8221; closed_title_font=&#8221;Avant Regular||||||||&#8221; closed_title_line_height=&#8221;26px&#8221; body_font=&#8221;Calibri Regular||||||||&#8221; body_text_color=&#8221;#000000&#8243; body_font_size=&#8221;12px&#8221; body_line_height=&#8221;18px&#8221; custom_margin=&#8221;0px||0px||false|false&#8221; custom_padding=&#8221;10px|0px|10px|0px|false|false&#8221; border_width_all=&#8221;0px&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<div class=\"ewa-rteLine\">Support development of grant application documents<\/div>\n<div class=\"ewa-rteLine\">Cost estimation<\/div>\n<p>[\/et_pb_toggle][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; custom_padding_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;1px||80px|||&#8221; custom_padding_tablet=&#8221;||48px||false|false&#8221; custom_padding_phone=&#8221;1px||48px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row _builder_version=&#8221;4.19.1&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.19.1&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_divider color=&#8221;#505358&#8243; divider_weight=&#8221;0.5px&#8221; _builder_version=&#8221;4.19.1&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;0px||34px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_divider][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_3,1_3,1_3&#8243; _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;0px||0px|||&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.19.1&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;Avant Regular||||||||&#8221; text_text_color=&#8221;#000000&#8243; text_font_size=&#8221;30px&#8221; text_line_height=&#8221;36px&#8221; custom_margin=&#8221;0px||10px||false|false&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p><span>Lab Services &amp; Facility<\/span><\/p>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;Calibri Regular||||||||&#8221; text_text_color=&#8221;#000000&#8243; text_font_size=&#8221;16px&#8221; text_line_height=&#8221;22px&#8221; link_font=&#8221;Calibro Bold||||||||&#8221; link_text_color=&#8221;#89bbe5&#8243; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>Contact our <a href=\"mailto:lorenz.burkhalter@dcberne.com\">Chief Operating Officer<\/a><\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.19.1&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;Calibri Regular||||||||&#8221; text_text_color=&#8221;#505358&#8243; text_font_size=&#8221;16px&#8221; text_line_height=&#8221;22px&#8221; custom_margin_tablet=&#8221;-16px||||false|false&#8221; custom_margin_phone=&#8221;-16px||||false|false&#8221; custom_margin_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p><span>You would like to conduct a study or research, but lack the appropriate premises and services?<\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.19.1&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_toggle title=&#8221;Our Lab &#038; Facility Services&#8221; open_toggle_text_color=&#8221;#000000&#8243; open_toggle_background_color=&#8221;RGBA(255,255,255,0)&#8221; closed_toggle_text_color=&#8221;#000000&#8243; closed_toggle_background_color=&#8221;RGBA(255,255,255,0)&#8221; icon_color=&#8221;#000000&#8243; toggle_icon=&#8221;&#x33;||divi||400&#8243; open_icon_color=&#8221;#89bbe5&#8243; open_toggle_icon=&#8221;&#x32;||divi||400&#8243; _builder_version=&#8221;4.23.1&#8243; _module_preset=&#8221;default&#8221; title_text_color=&#8221;#000000&#8243; title_font=&#8221;Avant Regular||||||||&#8221; title_font_size=&#8221;16px&#8221; title_line_height=&#8221;26px&#8221; closed_title_font=&#8221;Avant Regular||||||||&#8221; closed_title_line_height=&#8221;26px&#8221; body_font=&#8221;Calibri Regular||||||||&#8221; body_text_color=&#8221;#000000&#8243; body_font_size=&#8221;12px&#8221; body_line_height=&#8221;18px&#8221; custom_margin=&#8221;0px||0px||false|false&#8221; custom_padding=&#8221;10px|0px|10px|0px|false|false&#8221; border_width_all=&#8221;0px&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\"><span>Clinical Facility Space<\/span><\/div>\n<div class=\"ewa-rteLine\"><span>Overnight Clinical Space<\/span><\/div>\n<div class=\"ewa-rteLine\"><span>Bio Safety 2 Lab<\/span><\/div>\n<div class=\"ewa-rteLine\"><span>Office Space<\/span><\/div>\n<div class=\"ewa-rteLine\"><span>Meeting Space<\/span><\/div>\n<div class=\"ewa-rteLine\"><span>Project Space<\/span><\/div>\n<div class=\"ewa-rteLine\"><span>Storage Space (-150C\u00b0, -80\u00b0C, -20C\u00b0, 2-8 C\u00b0, RT )<\/span><\/div>\n<div class=\"ewa-rteLine\"><span>Storage and Environment Monitoring<\/span><\/div>\n<div class=\"ewa-rteLine\"><span>Consumables Management<\/span><\/div>\n<div class=\"ewa-rteLine\"><span>Medical Supply Management<\/span><\/div>\n<div class=\"ewa-rteLine\"><span>Medicine Supply Management<\/span><\/div>\n<div class=\"ewa-rteLine\"><span>Chemical Supply Management<\/span><\/div>\n<div class=\"ewa-rteLine\"><span>Equipment Management<\/span><\/div>\n<div class=\"ewa-rteLine\"><span>Experiment Setup Experience<\/span><\/div>\n<div class=\"ewa-rteLine\"><span>Measurement System Analysis Experience<\/span><\/div>\n<div class=\"ewa-rteLine\"><span>Root Cause Analyses and Investigation Experience<\/span><\/div>\n<div class=\"ewa-rteLine\"><span>Laboratory Management<\/span><\/div>\n<div class=\"ewa-rteLine\"><span>Safety Management<\/span><\/div>\n<div class=\"ewa-rteLine\"><span>GLP (Good Laboratory Practice) and GCLP (Good Clinical Laboratory Practice)<\/span><\/div>\n<div class=\"ewa-rteLine\"><span>Bioanalytics<\/span><\/div>\n<\/div>\n<p>[\/et_pb_toggle][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; custom_padding_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;1px||80px|||&#8221; custom_padding_tablet=&#8221;||48px||false|false&#8221; custom_padding_phone=&#8221;1px||48px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row _builder_version=&#8221;4.19.1&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.19.1&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_divider color=&#8221;#505358&#8243; divider_weight=&#8221;0.5px&#8221; _builder_version=&#8221;4.19.1&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;0px||34px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_divider][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_3,1_3,1_3&#8243; _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;0px||0px|||&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.19.1&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;Avant Regular||||||||&#8221; text_text_color=&#8221;#000000&#8243; text_font_size=&#8221;30px&#8221; text_line_height=&#8221;36px&#8221; custom_margin=&#8221;0px||10px||false|false&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p><span>Regulatory Services<\/span><\/p>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.19.5&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;Calibri Regular||||||||&#8221; text_text_color=&#8221;#000000&#8243; text_font_size=&#8221;16px&#8221; text_line_height=&#8221;22px&#8221; link_font=&#8221;Calibro Bold||||||||&#8221; link_text_color=&#8221;#89bbe5&#8243; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>Contact our <a href=\"mailto:stefanie.hossmann@dcberne.com; myriam.tinner@dcberne.com\">Regulatory Specialists<\/a><\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.19.1&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;Calibri Regular||||||||&#8221; text_text_color=&#8221;#505358&#8243; text_font_size=&#8221;16px&#8221; text_line_height=&#8221;22px&#8221; custom_margin_tablet=&#8221;-16px||||false|false&#8221; custom_margin_phone=&#8221;-16px||||false|false&#8221; custom_margin_last_edited=&#8221;on|tablet&#8221; custom_padding_last_edited=&#8221;off|desktop&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p><span>Are you working on a medical device or medical device software and struggling through the regulatory jungle? Do you know the &#8220;intended use&#8221; of your solution? Are you unsure how your device is classified and what it needs for market access in Europe (MDR) and the USA (FDA)? <\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.19.1&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_toggle title=&#8221;Our Regulatory Services&#8221; open_toggle_text_color=&#8221;#000000&#8243; open_toggle_background_color=&#8221;RGBA(255,255,255,0)&#8221; closed_toggle_text_color=&#8221;#000000&#8243; closed_toggle_background_color=&#8221;RGBA(255,255,255,0)&#8221; icon_color=&#8221;#000000&#8243; toggle_icon=&#8221;&#x33;||divi||400&#8243; open_icon_color=&#8221;#89bbe5&#8243; open_toggle_icon=&#8221;&#x32;||divi||400&#8243; _builder_version=&#8221;4.19.5&#8243; _module_preset=&#8221;default&#8221; title_text_color=&#8221;#000000&#8243; title_font=&#8221;Avant Regular||||||||&#8221; title_font_size=&#8221;16px&#8221; title_line_height=&#8221;26px&#8221; closed_title_font=&#8221;Avant Regular||||||||&#8221; closed_title_line_height=&#8221;26px&#8221; body_font=&#8221;Calibri Regular||||||||&#8221; body_text_color=&#8221;#000000&#8243; body_font_size=&#8221;12px&#8221; body_line_height=&#8221;18px&#8221; custom_margin=&#8221;0px||0px||false|false&#8221; custom_padding=&#8221;10px|0px|10px|0px|false|false&#8221; border_width_all=&#8221;0px&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">Quality Management System ISO 9001.2015<\/div>\n<div class=\"ewa-rteLine\">Deviation Management<\/div>\n<div class=\"ewa-rteLine\">OOX Management<\/div>\n<div class=\"ewa-rteLine\">CAPA Management<\/div>\n<div class=\"ewa-rteLine\">Change Management<\/div>\n<div class=\"ewa-rteLine\">Good Manufacturing Practice<\/div>\n<div class=\"ewa-rteLine\">Good Documentation Practice<\/div>\n<div class=\"ewa-rteLine\">Training Management<\/div>\n<div class=\"ewa-rteLine\">Risk Management<\/div>\n<div class=\"ewa-rteLine\">ISO 14155 Regulations<\/div>\n<div class=\"ewa-rteLine\">ISO 13485 Regulations<\/div>\n<div class=\"ewa-rteLine\">FDA \/ MDR go to market<\/div>\n<\/div>\n<\/div>\n<p>[\/et_pb_toggle][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; custom_padding_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;1px||80px|||&#8221; custom_padding_tablet=&#8221;||48px||false|false&#8221; custom_padding_phone=&#8221;1px||48px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row _builder_version=&#8221;4.19.1&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.19.1&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_divider color=&#8221;#505358&#8243; divider_weight=&#8221;0.5px&#8221; _builder_version=&#8221;4.19.1&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;0px||34px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_divider][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_3,1_3,1_3&#8243; _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;0px||0px|||&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.19.1&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;Avant Regular||||||||&#8221; text_text_color=&#8221;#000000&#8243; text_font_size=&#8221;30px&#8221; text_line_height=&#8221;36px&#8221; custom_margin=&#8221;0px||10px||false|false&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p><span>Data Services<\/span><\/p>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.19.5&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;Calibri Regular||||||||&#8221; text_text_color=&#8221;#000000&#8243; text_font_size=&#8221;16px&#8221; text_line_height=&#8221;22px&#8221; link_font=&#8221;Calibro Bold||||||||&#8221; link_text_color=&#8221;#89bbe5&#8243; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>Contact our <a href=\"mailto:datascience@dcberne.com\">Data Team<\/a><\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.19.1&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;Calibri Regular||||||||&#8221; text_text_color=&#8221;#505358&#8243; text_font_size=&#8221;16px&#8221; text_line_height=&#8221;22px&#8221; custom_margin_tablet=&#8221;-16px||||false|false&#8221; custom_margin_phone=&#8221;-16px||||false|false&#8221; custom_margin_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p><span>Does your solution generate a lot of data and do you want to analyse it? Are you developing an algorithm and would like to exchange ideas with experienced specialists \/ validate the algorithm? Are you unsure how to process and visualise your data in a statistically correct way?<\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.19.1&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_toggle title=&#8221;Our Data Services&#8221; open_toggle_text_color=&#8221;#000000&#8243; open_toggle_background_color=&#8221;RGBA(255,255,255,0)&#8221; closed_toggle_text_color=&#8221;#000000&#8243; closed_toggle_background_color=&#8221;RGBA(255,255,255,0)&#8221; icon_color=&#8221;#000000&#8243; toggle_icon=&#8221;&#x33;||divi||400&#8243; open_icon_color=&#8221;#89bbe5&#8243; open_toggle_icon=&#8221;&#x32;||divi||400&#8243; _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; title_text_color=&#8221;#000000&#8243; title_font=&#8221;Avant Regular||||||||&#8221; title_font_size=&#8221;16px&#8221; title_line_height=&#8221;26px&#8221; closed_title_font=&#8221;Avant Regular||||||||&#8221; closed_title_line_height=&#8221;26px&#8221; body_font=&#8221;Calibri Regular||||||||&#8221; body_text_color=&#8221;#000000&#8243; body_font_size=&#8221;12px&#8221; body_line_height=&#8221;18px&#8221; custom_margin=&#8221;0px||0px||false|false&#8221; custom_padding=&#8221;10px|0px|10px|0px|false|false&#8221; border_width_all=&#8221;0px&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\"><span>Secure data storage &#8211; safe harbour for clinical data<\/span><\/div>\n<div class=\"ewa-rteLine\"><span>Access to data<\/span><\/div>\n<div class=\"ewa-rteLine\"><span>Validation of algorithm<\/span><\/div>\n<div class=\"ewa-rteLine\"><span>Algorithm development<\/span><\/div>\n<div class=\"ewa-rteLine\"><span>Statistical Analysis<\/span><\/div>\n<div class=\"ewa-rteLine\"><span>CRF Design and Implementation<\/span><\/div>\n<\/div>\n<\/div>\n<\/div>\n<p>[\/et_pb_toggle][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; custom_padding_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;1px||80px|||&#8221; custom_padding_tablet=&#8221;||48px||false|false&#8221; custom_padding_phone=&#8221;1px||48px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row _builder_version=&#8221;4.19.1&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.19.1&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_divider color=&#8221;#505358&#8243; divider_weight=&#8221;0.5px&#8221; _builder_version=&#8221;4.19.1&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;0px||34px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_divider][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_3,1_3,1_3&#8243; _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;0px||0px|||&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.19.1&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;Avant Regular||||||||&#8221; text_text_color=&#8221;#000000&#8243; text_font_size=&#8221;30px&#8221; text_line_height=&#8221;36px&#8221; custom_margin=&#8221;0px||10px||false|false&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p><span>Business Services<\/span><\/p>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.19.5&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;Calibri Regular||||||||&#8221; text_text_color=&#8221;#000000&#8243; text_font_size=&#8221;16px&#8221; text_line_height=&#8221;22px&#8221; link_font=&#8221;Calibro Bold||||||||&#8221; link_text_color=&#8221;#89bbe5&#8243; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>Contact our<a href=\"mailto:innovation@dcberne.com\"> Innovation Team<\/a><\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.19.1&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;Calibri Regular||||||||&#8221; text_text_color=&#8221;#505358&#8243; text_font_size=&#8221;16px&#8221; text_line_height=&#8221;22px&#8221; custom_margin_tablet=&#8221;-16px||||false|false&#8221; custom_margin_phone=&#8221;-16px||||false|false&#8221; custom_margin_last_edited=&#8221;on|tablet&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p><span>Do you have an idea, but are unsure whether and how it can be turned into a business model? Do you want to validate your business idea? Do you need a business case review? Do you want to start a company and are looking for selective support?<\/span><\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.19.1&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_toggle title=&#8221;Our Business Services&#8221; open_toggle_text_color=&#8221;#000000&#8243; open_toggle_background_color=&#8221;RGBA(255,255,255,0)&#8221; closed_toggle_text_color=&#8221;#000000&#8243; closed_toggle_background_color=&#8221;RGBA(255,255,255,0)&#8221; icon_color=&#8221;#000000&#8243; toggle_icon=&#8221;&#x33;||divi||400&#8243; open_icon_color=&#8221;#89bbe5&#8243; open_toggle_icon=&#8221;&#x32;||divi||400&#8243; _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; title_text_color=&#8221;#000000&#8243; title_font=&#8221;Avant Regular||||||||&#8221; title_font_size=&#8221;16px&#8221; title_line_height=&#8221;26px&#8221; closed_title_font=&#8221;Avant Regular||||||||&#8221; closed_title_line_height=&#8221;26px&#8221; body_font=&#8221;Calibri Regular||||||||&#8221; body_text_color=&#8221;#000000&#8243; body_font_size=&#8221;12px&#8221; body_line_height=&#8221;18px&#8221; custom_margin=&#8221;0px||0px||false|false&#8221; custom_padding=&#8221;10px|0px|10px|0px|false|false&#8221; border_width_all=&#8221;0px&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">\n<div class=\"ewa-rteLine\">Business Model creation and validation<\/div>\n<div class=\"ewa-rteLine\">User Research<\/div>\n<div class=\"ewa-rteLine\">Lean Startup principles<\/div>\n<div class=\"ewa-rteLine\">Project Management<\/div>\n<div class=\"ewa-rteLine\">Incorporation<\/div>\n<div class=\"ewa-rteLine\">Business Case validation<\/div>\n<div class=\"ewa-rteLine\">Marketing Strategy<\/div>\n<div class=\"ewa-rteLine\">Customer-\/patient journey mappings<\/div>\n<div class=\"ewa-rteLine\">Product Development<\/div>\n<div class=\"ewa-rteLine\">Financial- and HR Services<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p>[\/et_pb_toggle][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; custom_padding_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; min_height=&#8221;321.8px&#8221; custom_padding=&#8221;1px||120px|||&#8221; custom_padding_tablet=&#8221;1px||120px|||&#8221; custom_padding_phone=&#8221;1px||80px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row _builder_version=&#8221;4.19.1&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.19.1&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_divider color=&#8221;#505358&#8243; divider_weight=&#8221;0.5px&#8221; _builder_version=&#8221;4.19.1&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;0px||34px||false|false&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_divider][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=&#8221;1_3,1_3,1_3&#8243; custom_padding_last_edited=&#8221;on|tablet&#8221; _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;0px||80px||false|false&#8221; custom_padding_tablet=&#8221;||48px||false|false&#8221; custom_padding_phone=&#8221;||48px||false|false&#8221; border_width_bottom=&#8221;0.5px&#8221; border_color_bottom=&#8221;#505358&#8243; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.19.1&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;Avant Regular||||||||&#8221; text_text_color=&#8221;#000000&#8243; text_font_size=&#8221;30px&#8221; text_line_height=&#8221;36px&#8221; custom_margin=&#8221;0px||10px||false|false&#8221; custom_padding=&#8221;0px||0px||false|false&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p><span>Marketing &amp; Communication Services<\/span><\/p>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.19.5&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;Calibri Regular||||||||&#8221; text_text_color=&#8221;#000000&#8243; text_font_size=&#8221;16px&#8221; text_line_height=&#8221;22px&#8221; link_font=&#8221;Calibro Bold||||||||&#8221; link_text_color=&#8221;#89bbe5&#8243; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>Contact our <a href=\"mailto:medien@dcberne.com\"> Communication Team<\/a><\/p>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.19.1&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.19.4&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;Calibri Regular||||||||&#8221; text_text_color=&#8221;#505358&#8243; text_font_size=&#8221;16px&#8221; text_line_height=&#8221;22px&#8221; custom_margin_tablet=&#8221;-16px||||false|false&#8221; custom_margin_phone=&#8221;-16px||||false|false&#8221; custom_margin_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p><span>You have a brilliant idea or maybe even a product and nobody knows about it? Do you want to present your idea to potential investors and need support with your pitch? 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