{"id":3356,"date":"2022-02-23T11:06:59","date_gmt":"2022-02-23T11:06:59","guid":{"rendered":"https:\/\/pharma-expertise.com\/?page_id=3356"},"modified":"2022-10-26T14:41:44","modified_gmt":"2022-10-26T14:41:44","slug":"clinical-studies","status":"publish","type":"page","link":"https:\/\/pharma-expertise.com\/en\/clinical-studies\/","title":{"rendered":"Clinical Studies"},"content":{"rendered":"

[et_pb_section fb_built=”1″ fullwidth=”on” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_fullwidth_image src=”https:\/\/pharma-expertise.com\/wp-content\/uploads\/2021\/10\/top_pharma-arzneimittel-min.jpg” alt=”Pharma & Arzneimittel” title_text=”Arzneimittel” _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_fullwidth_image][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.16″ _module_preset=”default” global_colors_info=”{}”][et_pb_row _builder_version=”4.16″ custom_margin=”||0px||false|false” custom_padding=”0px||0px||false|false” locked=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.16″ custom_padding=”|||” global_colors_info=”{}” custom_padding__hover=”|||”][et_pb_text _builder_version=”4.17.3″ text_font=”||||||||” text_line_height=”2em” header_font=”Manrope|600|||||||” header_text_color=”#20292f” header_font_size=”26px” header_line_height=”1.3em” header_2_font=”Manrope|600||on|||||” header_2_text_color=”#193b7a” header_2_font_size=”14px” header_2_letter_spacing=”1px” header_2_line_height=”1.2em” header_3_font=”Manrope|500|||||||” header_3_font_size=”20px” header_3_line_height=”1.4em” custom_margin=”0px||0px||false|false” header_2_font_size_tablet=”42px” header_2_font_size_phone=”32px” header_2_font_size_last_edited=”off|desktop” header_3_font_size_tablet=”28px” header_3_font_size_phone=”20px” header_3_font_size_last_edited=”on|phone” locked=”off” global_colors_info=”{}”]<\/p>\n

Clinical studies<\/h2>\n

From the planning of the study design to the final study report and marketing authorization<\/h1>\n

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Pharma Expertise Consulting accompanies you both in the conduct of in vitro trials<\/strong> prior to clinical studies <\/strong>(Fraunhofer Institutes etc.) and in the planning and execution of a Phase II to IV clinical trial by a Contract Research Organization (CRO)<\/strong> or a contract research organization. We work strictly according to Good Clinical Practice (GCP)<\/strong>, the German Data Protection Regulation (DSGVO) and national and international laws and guidelines.<\/p>\n

We support you in all tasks: the organization<\/strong> and planning of the study,<\/strong> selection of a suitable CRO<\/strong>, contracting<\/strong> (delimitation of responsibility contracts), observation plan<\/strong>\u00a0or study protocol<\/strong> (synopsis), submission\/notification<\/strong> to the authorities Federal Institute for Drugs and Medical Devices (BfArM)<\/strong><\/a>, ethics committees, and umbrella organization of the health insurance funds<\/strong><\/a>), database creation<\/strong> and randomization<\/strong>, monitoring <\/strong>and data collection<\/strong>, and statistical analyses<\/strong> (biometrics or biostatistics) in a Statistical Analysis Plan<\/strong> (SAP), as well as the final report in the context of medical writing.<\/p>\n

We take over individual services, but also offer a full service. Please do not hesitate to contact us!<\/strong><\/p>\n

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Our services in the field of clinical trials of pharmaceuticals:<\/h2>\n

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Planning<\/strong> of the study design\/
Study procedure
<\/strong><\/p>\n

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Selection <\/strong>of qualified study sites \/ contract design<\/strong><\/p>\n

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Audits <\/strong>for review <\/strong>and evaluation <\/strong>of study centers<\/strong><\/p>\n

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Instruction<\/strong> of investigators<\/strong><\/p>\n

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Communication with authorities<\/strong>
(approvals<\/strong> of the ethics committee<\/strong> etc.)<\/p>\n

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Conclusion of patient insurance policies<\/p>\n

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Compliance with the study plan \/ legally compliant conduct of the study in accordance with Good Clinical Practice<\/p>\n

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Statistical evaluations<\/strong><\/p>\n

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Control <\/strong>of compliance <\/strong>with timelines \/ <\/strong>planned study budget
<\/strong><\/p>\n

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Remuneration <\/strong>of the study physicians<\/strong><\/p>\n

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Monitoring \/ communication <\/strong>with the clinical research associates (CRAs) <\/strong>at the study sites, <\/strong>Principal Investigator <\/strong>and the sponsor
<\/strong><\/p>\n

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Source Data Verification (SDV) <\/strong>through CRA-compliant reporting <\/strong>of serious adverse events<\/strong>
(SAEs)<\/strong><\/p>\n

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Registration <\/strong>of study results<\/strong> in the appropriate databases<\/strong><\/p>\n

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Clinical studies From the planning of the study design to the final study report and marketing authorizationPharma Expertise Consulting accompanies you both in the conduct of in vitro trials prior to clinical studies (Fraunhofer Institutes etc.) and in the planning and execution of a Phase II to IV clinical trial by a Contract Research Organization […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","inline_featured_image":false,"footnotes":""},"class_list":["post-3356","page","type-page","status-publish","hentry"],"yoast_head":"\nClincial trials \u00bb FDA Good clinical practice GCP<\/title>\n<meta name=\"description\" content=\"Our clincial services: clinical trials \u2714 patient recruitment \u2714 GCP \u2714 Ethics Committee \u2714 Study Design \u2714 Study Site \u2714 CRO \u2714 IB investigator\u2714 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