{"id":12294,"date":"2025-03-31T08:23:39","date_gmt":"2025-03-31T07:23:39","guid":{"rendered":"https:\/\/www.thervacb.eu\/equip\/socratec\/"},"modified":"2025-04-08T09:41:49","modified_gmt":"2025-04-08T08:41:49","slug":"socratec","status":"publish","type":"page","link":"https:\/\/www.thervacb.eu\/ca\/equip\/socratec\/","title":{"rendered":"SocraTec"},"content":{"rendered":"

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\"Hospital<\/a><\/p>\n

[\/et_pb_map_pin_extended][et_pb_map_pin_extended title=”Fundaci\u00f3 Cl\u00ednic per a la Recerca Biom\u00e8dica ” pin_address=”Carrer del Rossell\u00f3, 149, 08036 Barcelona, Spanien” pin_address_lat=”41.3885899″ pin_address_lng=”2.1508862″ pin_fill_color=”#2d788c” pin_stroke_color=”#06423a” pin_circle_color=”#ffffff” _builder_version=”4.21.0″ global_colors_info=”{}”]<\/p>\n

\"Fundaci\u00f3<\/a><\/p>\n

[\/et_pb_map_pin_extended][et_pb_map_pin_extended title=”Helmholtz-Zentrum f\u00fcr Infektionsforschung GmbH (HZI)” pin_address=”Ingolst\u00e4dter Landstra\u00dfe 1, 85764 Oberschlei\u00dfheim, Deutschland” pin_address_lat=”48.2208172″ pin_address_lng=”11.5871674″ pin_fill_color=”#2d788c” pin_stroke_color=”#06423a” pin_circle_color=”#ffffff” _builder_version=”4.21.0″ global_colors_info=”{}”]<\/p>\n

\"Helmholtz-Zentrum<\/a><\/p>\n

[\/et_pb_map_pin_extended][et_pb_map_pin_extended title=”Helmholtz Munich” pin_address=”Inhoffenstra\u00dfe 7, 38124 Braunschweig, Deutschland” pin_address_lat=”52.2109803″ pin_address_lng=”10.5314925″ pin_fill_color=”#2d788c” pin_stroke_color=”#06423a” pin_circle_color=”#ffffff” _builder_version=”4.25.0″ global_colors_info=”{}”]\"Helmholtz<\/a>[\/et_pb_map_pin_extended][et_pb_map_pin_extended title=”Medizinische Hochschule Hannover” pin_address=”Carl-Neuberg-Stra\u00dfe 1, 30625 Hannover, Deutschland” pin_address_lat=”52.3834749″ pin_address_lng=”9.8047999″ pin_fill_color=”#2d788c” pin_stroke_color=”#06423a” pin_circle_color=”#ffffff” _builder_version=”4.21.0″ global_colors_info=”{}”]<\/p>\n

\"MHH\"<\/a><\/p>\n

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\"NIMR-Mbeya<\/a><\/p>\n

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\"\u6c64\u59c6\"<\/a> <\/p>\n

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\"UNIVERSITY<\/a><\/p>\n

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\"Klinikum<\/a><\/p>\n

[\/et_pb_map_pin_extended][et_pb_map_pin_extended title=”UKE Hamburg Eppendorf” pin_address=”Martinistra\u00dfe 52, 20251 Hamburg, Deutschland” pin_address_lat=”53.5902421″ pin_address_lng=”9.9785922″ pin_fill_color=”#2d788c” pin_stroke_color=”#06423a” pin_circle_color=”#ffffff” _builder_version=”4.25.0″ global_colors_info=”{}”]\"UKE<\/a>[\/et_pb_map_pin_extended][et_pb_map_pin_extended title=”Azienda Ospedaliero- Universitaria di Parma” pin_address=”Str. dell’Universit\u00e0, 12, 43121 Parma PR, Italien” pin_address_lat=”44.8012357″ pin_address_lng=”10.3255389″ pin_fill_color=”#2d788c” pin_stroke_color=”#06423a” pin_circle_color=”#ffffff” _builder_version=”4.21.0″ global_colors_info=”{}”]\"Azienda<\/a>[\/et_pb_map_pin_extended][et_pb_map_pin_extended title=”Universit\u00e4tsklinikum Leipzig” pin_address=”Ritterstra\u00dfe 26, 04109 Leipzig, Deutschland” pin_address_lat=”51.3412809″ pin_address_lng=”12.3802676″ pin_fill_color=”#2d788c” pin_stroke_color=”#06423a” pin_circle_color=”#ffffff” _builder_version=”4.25.0″ global_colors_info=”{}”]\"Universit\u00e4tsklinikum<\/a>[\/et_pb_map_pin_extended][et_pb_map_pin_extended title=”Barts Health NHS Trust” pin_address=”Co-operative Bank Plc, 9 Prescot St, Whitechapel, London E1 8AZ, Vereinigtes K\u00f6nigreich” zoom_level=”5″ pin_address_lat=”51.5115034″ pin_address_lng=”-0.0706499″ pin_fill_color=”#2d788c” pin_stroke_color=”#06423a” pin_circle_color=”#ffffff” _builder_version=”4.21.0″ global_colors_info=”{}”]<\/p>\n

\"Barts<\/a><\/p>\n

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\"ARTTIC<\/a><\/p>\n

[\/et_pb_map_pin_extended][et_pb_map_pin_extended title=”SocraTec R&D GmbH” pin_address=”Im Setzling 35, 61440 Oberursel (Taunus), Deutschland” pin_address_lat=”50.1968591″ pin_address_lng=”8.5860136″ pin_fill_color=”#2d788c” pin_stroke_color=”#06423a” pin_circle_color=”#ffffff” _builder_version=”4.25.0″ overflow-x=”hidden” overflow-y=”hidden” display_conditions=”W3siaWQiOiJkYTM2ZDRmMi05ZjgxLTQ4NTEtOWVjMC04NDc5MWNiYWNmODciLCJjb25kaXRpb24iOiJkYXRlQXJjaGl2ZSIsImNvbmRpdGlvblNldHRpbmdzIjp7ImRpc3BsYXlSdWxlIjoiaXNBZnRlciIsImRhdGVBcmNoaXZlIjoiMjAyNS0wMy0yNyIsImFkbWluTGFiZWwiOiJEYXRlIEFyY2hpdmUiLCJlbmFibGVDb25kaXRpb24iOiJvbiJ9LCJvcGVyYXRvciI6Ik9SIn1d” global_colors_info=”{}”]\"SocraTec<\/a>[\/et_pb_map_pin_extended][\/et_pb_map_fullwidth_extended][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.16″ da_disable_devices=”off|off|off” global_colors_info=”{}” da_is_popup=”off” da_exit_intent=”off” da_has_close=”on” da_alt_close=”off” da_dark_close=”off” da_not_modal=”on” da_is_singular=”off” da_with_loader=”off” da_has_shadow=”on”][et_pb_row column_structure=”3_4,1_4″ _builder_version=”4.16″ global_colors_info=”{}”][et_pb_column type=”3_4″ _builder_version=”4.16″ global_colors_info=”{}”][et_pb_text _builder_version=”4.25.0″ global_colors_info=”{}”]<\/p>\n

SocraTec R&D GmbH<\/h1>\n

Informaci\u00f3 general<\/h2>\n

SocraTec R&D GmbH \u00e9s una organitzaci\u00f3 d’investigaci\u00f3 per contracte (CRO) de serveis complets, que realitza professionalment estudis cl\u00ednics des de 1998. Operen les seves pr\u00f2pies Unitats de Farmacologia Cl\u00ednica (CPU) d’\u00faltima generaci\u00f3 dedicada a la realitzaci\u00f3 cl\u00ednica d’assaigs de fase inicial en subjectes i pacients sans. L’equip d’R&D de SocraTec, amb seu a tres ubicacions a Alemanya, est\u00e0 especialitzat en solucions d’investigaci\u00f3 cl\u00ednica en el desenvolupament de f\u00e0rmacs en fase inicial i tardana. Proporcionen tota la gamma de serveis d’investigaci\u00f3 cl\u00ednica a les ind\u00fastries farmac\u00e8utiques, biotecnol\u00f2giques i de dispositius m\u00e8dics i gestionen i realitzen estudis cl\u00ednics des de la primera aplicaci\u00f3 en humans, passant per la prova de concepte en la poblaci\u00f3 de pacients, fins a estudis d’efic\u00e0cia en les \u00faltimes etapes de les proves cl\u00edniques.
Els serveis inclouen consultoria cient\u00edfica d’experts l\u00edders per al desenvolupament del disseny d’estudis, assessorament cient\u00edfic i declaracions d’experts, realitzaci\u00f3 cl\u00ednica d’estudis fase I-IV, garantia de qualitat, seguiment, gesti\u00f3 de dades, bioestad\u00edstica i farmacocin\u00e8tica, redacci\u00f3 m\u00e8dica i farmacovigil\u00e0ncia.
Fins ara, SocraTec ha dut a terme diversos centenars d’assaigs de Fase I, incloent estudis de vacunaci\u00f3 i primers en humans, aix\u00ed com estudis que avaluen la biodisponibilitat (com s’absorbeixen i utilitzen els f\u00e0rmacs pel cos) amb diverses formes de dosificaci\u00f3 i m\u00e8todes de lliurament, com ara comprimits, injeccions i pegats transd\u00e8rmics. La seva experi\u00e8ncia abasta proves cl\u00edniques de mol\u00e8cules petites i productes biol\u00f2gics.
Amb la seva experi\u00e8ncia substancial en la realitzaci\u00f3 d’assajos nacionals i internacionals, SocraTec R&D es compromet a donar suport al projecte TherVacB i avan\u00e7ar en tractaments innovadors per a l’hepatitis B.<\/p>\n

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SocraTec R&D GmbH<\/strong><\/p>\n

Seu
S\u00f3c Setzling 35
61440 Oberursel
Alemanya
enlla\u00e7<\/a><\/p>\n

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Rol a TherVacB<\/h2>\n

SocraTec R&D t\u00e9 un paper vital en el projecte TherVacB gestionant i executant l’assaig cl\u00ednic. Supervisen la gesti\u00f3 i el seguiment dels assaigs cl\u00ednics, garantint l’organitzaci\u00f3 professional i la realitzaci\u00f3 de l’assaig mitjan\u00e7ant visites in situ que confirmen l’exactitud i el compliment de les dades. A m\u00e9s, el grup de gesti\u00f3 de projectes de SocraTec R&D gestiona les presentacions i aprovacions reguladores tant a la UE com al Regne Unit, assegurant-se que totes les presentacions compleixen els est\u00e0ndards legals i \u00e8tics. L’equip coordina el projecte cl\u00ednic facilitant la col\u00b7laboraci\u00f3, fent un seguiment del progr\u00e9s i abordant els reptes. A m\u00e9s, SocraTec R&D s’encarrega de la presentaci\u00f3 d’informes, que inclou la redacci\u00f3 de l’Informe de l’Estudi Cl\u00ednic i l’elaboraci\u00f3 d’un resum per a profe per fer que els resultats siguin accessibles tant als investigadors professionals com al p\u00fablic.<\/p>\n

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Personal del projecte<\/h2>\n

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\u00c9s un farmac\u00e8utic amb una \u00e0mplia experi\u00e8ncia en investigaci\u00f3 cl\u00ednica i gesti\u00f3 d’assaigs. Andr\u00e9 Warnke es va incorporar a SocraTec R&D l’any 2004 com a director de projecte, jugant un paper clau en l’ampliaci\u00f3 de la cartera d’assaigs cl\u00ednics de la companyia. L’any 2012 va esdevenir membre del consell d’administraci\u00f3 i director general. La seva experi\u00e8ncia abasta el disseny, la realitzaci\u00f3, el seguiment i la presentaci\u00f3 d’assaigs, amb un enfocament en malalties respirat\u00f2ries, oftalmologia, ginecologia, oncologia, gesti\u00f3 del dolor i nefrologia.<\/p>\n

[\/et_pb_team_member][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.16″ global_colors_info=”{}”][et_pb_team_member name=”Maria Ansch\u00fctz” position=”Cap de gesti\u00f3 de projectes cl\u00ednics” image_url=”https:\/\/www.thervacb.eu\/wp-content\/uploads\/anschuetz-maria.jpg” _builder_version=”4.25.0″ header_text_align=”center” position_text_align=”center” position_line_height=”2em” text_orientation=”left” custom_padding=”40px|20px|20px|20px|false|false” custom_css_member_image=”-webkit-clip-path: circle(45% at 50% 68%);||clip-path: circle(43% at 50% 68%);||margin-top:-20px;||height:160px;||margin-left: auto;||margin-right: auto;||” custom_css_member_description=”margin-top:80px” border_radii=”on|10px|10px|10px|10px” box_shadow_style=”preset1″ global_colors_info=”{}”]<\/p>\n

\u00c9s farmac\u00e8utica i experta en investigaci\u00f3 cl\u00ednica amb una \u00e0mplia experi\u00e8ncia en assaigs de fase inicial. Maria Ansch\u00fctz dirigeix \u200b\u200bel departament de gesti\u00f3 de projectes per a assaigs cl\u00ednics de SocraTec R&D, assegurant el compliment i una execuci\u00f3 d’alta qualitat. Amb una s\u00f2lida formaci\u00f3 en processos regulatoris, supervisa la realitzaci\u00f3 de les proves, la documentaci\u00f3 i els informes. Per al projecte TherVacB, \u00e9s responsable de la gesti\u00f3 del projecte, la regulaci\u00f3 i la coordinaci\u00f3 de l’execuci\u00f3 d’assaigs amb el seu equip de caps de projecte i assistents.<\/p>\n

[\/et_pb_team_member][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.16″ global_colors_info=”{}”][et_pb_team_member name=”Sarah Spriestersbach” position=”Cap de seguiment cl\u00ednic” image_url=”https:\/\/www.thervacb.eu\/wp-content\/uploads\/spriestersbach-sarah.jpg” _builder_version=”4.25.0″ header_text_align=”center” position_text_align=”center” position_line_height=”2em” text_orientation=”left” custom_padding=”40px|20px|20px|20px|false|false” custom_css_member_image=”-webkit-clip-path: circle(45% at 50% 68%);||clip-path: circle(43% at 50% 68%);||margin-top:-20px;||height:160px;||margin-left: auto;||margin-right: auto;||” custom_css_member_description=”margin-top:80px” border_radii=”on|10px|10px|10px|10px” box_shadow_style=”preset1″ global_colors_info=”{}”]<\/p>\n

\u00c9s una farmac\u00e8utica amb experi\u00e8ncia en gesti\u00f3 i seguiment d’assaigs cl\u00ednics. Sarah Spriestersbach es va incorporar a SocraTec R&D el 2021 i es va convertir en cap de la divisi\u00f3 de monitoratge el 2022, supervisant l’equip de monitors. T\u00e9 experi\u00e8ncia amb assaigs mono i multic\u00e8ntrics, estudis de dispositius m\u00e8dics i assaigs virtuals. Per al projecte TherVacB, aporta la seva experi\u00e8ncia en gesti\u00f3 i seguiment de projectes per garantir una execuci\u00f3 de proves d’alta qualitat.<\/p>\n

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SocraTec R&D GmbH Informaci\u00f3 general SocraTec R&D GmbH \u00e9s una organitzaci\u00f3 d’investigaci\u00f3 per contracte (CRO) de serveis complets, que realitza professionalment estudis cl\u00ednics des de 1998. Operen les seves pr\u00f2pies Unitats de Farmacologia Cl\u00ednica (CPU) d’\u00faltima generaci\u00f3 dedicada a la realitzaci\u00f3 cl\u00ednica d’assaigs de fase inicial en subjectes i pacients sans. L’equip d’R&D de SocraTec, […]<\/p>\n","protected":false},"author":5,"featured_media":12246,"parent":3533,"menu_order":18,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":"","_links_to":"","_links_to_target":""},"class_list":["post-12294","page","type-page","status-publish","has-post-thumbnail","hentry"],"aioseo_notices":[],"aioseo_head":"\n\t\t\n\t\n\t\n\t\n\t\n\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t