{"id":1018,"date":"2026-03-23T19:18:41","date_gmt":"2026-03-23T18:18:41","guid":{"rendered":"https:\/\/criteriamedica.com\/clinical-trials\/"},"modified":"2026-09-03T13:05:59","modified_gmt":"2026-09-03T11:05:59","slug":"clinical-trials","status":"publish","type":"page","link":"https:\/\/criteriamedica.com\/en\/clinical-trials\/","title":{"rendered":"Clinical Trials"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.27.5&#8243; _module_preset=&#8221;default&#8221; background_enable_color=&#8221;off&#8221; background_image=&#8221;https:\/\/criteriamedica.com\/wp-content\/uploads\/2026\/03\/Imagen-principal-servicios-ensayos-clinicos.jpg&#8221; background_position=&#8221;top_center&#8221; background_vertical_offset=&#8221;41%&#8221; background_enable_video_mp4=&#8221;off&#8221; background_enable_mask_style=&#8221;on&#8221; background_mask_style=&#8221;square-stripes&#8221; background_mask_color=&#8221;RGBA(255,255,255,0)&#8221; min_height=&#8221;70vh&#8221; custom_margin=&#8221;0px||||false|false&#8221; custom_padding=&#8221;0px||0px|||&#8221; background_last_edited=&#8221;on|phone&#8221; background_image_tablet=&#8221;https:\/\/criteriamedica.com\/wp-content\/uploads\/2026\/03\/Imagen-principal-servicios-ensayos-clinicos.jpg&#8221; background_image_phone=&#8221;https:\/\/criteriamedica.com\/wp-content\/uploads\/2026\/03\/Imagen-principal-servicios-ensayos-clinicos.jpg&#8221; background_enable_image_tablet=&#8221;on&#8221; background_enable_image_phone=&#8221;on&#8221; background_position_tablet=&#8221;top_left&#8221; background_position_phone=&#8221;top_left&#8221; background_horizontal_offset_tablet=&#8221;53%&#8221; background_horizontal_offset_phone=&#8221;74%&#8221; background_vertical_offset_tablet=&#8221;0%&#8221; custom_css_main_element=&#8221;display: flex;||align-items: center;&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row _builder_version=&#8221;4.27.5&#8243; _module_preset=&#8221;default&#8221; width_tablet=&#8221;&#8221; width_phone=&#8221;90%&#8221; width_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.27.5&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text content_tablet=&#8221;<\/p>\n<p>Expert Medical Opinion<br \/>in Clinical Trials<\/p>\n<p>&#8221; content_phone=&#8221;<\/p>\n<p>Expert Medical Opinion in Clinical Trials<\/p>\n<p>&#8221; content_last_edited=&#8221;on|desktop&#8221; _builder_version=&#8221;4.27.5&#8243; _module_preset=&#8221;default&#8221; text_text_color=&#8221;#FFFFFF&#8221; text_font_size=&#8221;37px&#8221; text_line_height=&#8221;1.3em&#8221; text_orientation=&#8221;center&#8221; custom_padding=&#8221;|160px||160px|false|true&#8221; custom_padding_tablet=&#8221;|40px||40px|false|true&#8221; custom_padding_phone=&#8221;|40px||40px|false|false&#8221; custom_padding_last_edited=&#8221;on|desktop&#8221; text_font_size_tablet=&#8221;37px&#8221; text_font_size_phone=&#8221;27px&#8221; text_font_size_last_edited=&#8221;on|phone&#8221; text_line_height_tablet=&#8221;1.3em&#8221; text_line_height_phone=&#8221;1.1em&#8221; text_line_height_last_edited=&#8221;on|phone&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p>Expert Medical Opinion<br \/>in Clinical Trials<\/p>\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;4.27.5&#8243; _module_preset=&#8221;default&#8221; width=&#8221;100%&#8221; max_width=&#8221;1200px&#8221; module_alignment=&#8221;center&#8221; custom_padding=&#8221;||3px|||&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row _builder_version=&#8221;4.27.5&#8243; _module_preset=&#8221;default&#8221; width=&#8221;85%&#8221; width_tablet=&#8221;80%&#8221; width_phone=&#8221;80%&#8221; width_last_edited=&#8221;on|phone&#8221; module_alignment=&#8221;center&#8221; custom_padding=&#8221;||37px|||&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.27.5&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text content_tablet=&#8221;<\/p>\n<h1 style=%22text-align: left;%22>EXPERT MEDICAL OPINION IN CLINICAL TRIALS WITH MEDICINES AND MEDICAL DEVICES FOR HUMAN USE<\/h1>\n<p>&#8221; content_phone=&#8221;<\/p>\n<h1 style=%22text-align: left;%22>EXPERT MEDICAL OPINION IN CLINICAL TRIALS WITH MEDICINES AND MEDICAL DEVICES FOR HUMAN USE<\/h1>\n<p>&#8221; content_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.27.5&#8243; _module_preset=&#8221;default&#8221; text_text_color=&#8221;#00638E&#8221; text_font_size=&#8221;24px&#8221; text_line_height=&#8221;1.3em&#8221; header_font=&#8221;|700|||||||&#8221; header_text_color=&#8221;#4C565C&#8221; header_line_height=&#8221;1.2em&#8221; text_orientation=&#8221;center&#8221; custom_margin=&#8221;||0px|||&#8221; custom_padding=&#8221;|70px|10px|70px|false|true&#8221; custom_padding_tablet=&#8221;||10px|0px|false|false&#8221; custom_padding_phone=&#8221;||10px||false|false&#8221; custom_padding_last_edited=&#8221;on|desktop&#8221; header_font_size_tablet=&#8221;24px&#8221; header_font_size_phone=&#8221;24px&#8221; header_font_size_last_edited=&#8221;on|phone&#8221; header_2_font_size_tablet=&#8221;&#8221; header_2_font_size_phone=&#8221;&#8221; header_2_font_size_last_edited=&#8221;on|desktop&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h1 style=\"text-align: center;\">EXPERT MEDICAL OPINION IN CLINICAL TRIALS WITH MEDICINES AND MEDICAL DEVICES FOR HUMAN USE<\/h1>\n<p>[\/et_pb_text][et_pb_text content_tablet=&#8221;<\/p>\n<p>Clinical trials constitute the fundamental pillar of the development of new treatments, allowing for the evaluation of their safety, efficacy, and applicability in humans under a highly demanding regulatory framework.<\/p>\n<p>They are structured into different phases\u2014from the first administration in humans (Phase I) to evaluation in real clinical practice (Phase IV)\u2014each with specific scientific objectives and ethical requirements. The correct execution of these phases is critical both for the validity of the results and for the protection of participants. <\/p>\n<p>Our firm offers highly specialized expert advice in the field of clinical research, providing independent, rigorous, and technically sound analyses in judicial and extrajudicial proceedings.<\/p>\n<p>The reports are prepared by professionals who actively participate in conducting clinical trials, which provides direct and up-to-date knowledge of real clinical practice, as well as a deep understanding of the methodological, regulatory, and ethical aspects involved.<\/p>\n<p>This approach allows for a comprehensive evaluation of clinical trials in all their phases with a multidisciplinary and evidence-based perspective.<\/p>\n<p>We intervene in the preparation of expert reports in situations that require a high degree of specialization, including:<\/p>\n<p>&#8221; content_phone=&#8221;<\/p>\n<p>Clinical trials constitute the fundamental pillar of the development of new treatments, allowing for the evaluation of their safety, efficacy, and applicability in humans under a highly demanding regulatory framework.<\/p>\n<p>They are structured into different phases\u2014from the first administration in humans (Phase I) to evaluation in real clinical practice (Phase IV)\u2014each with specific scientific objectives and ethical requirements. The correct execution of these phases is critical both for the validity of the results and for the protection of participants. <\/p>\n<p>Our firm offers highly specialized expert advice in the field of clinical research, providing independent, rigorous, and technically sound analyses in judicial and extrajudicial proceedings.<\/p>\n<p>The reports are prepared by professionals who actively participate in conducting clinical trials, which provides direct and up-to-date knowledge of real clinical practice, as well as a deep understanding of the methodological, regulatory, and ethical aspects involved.<\/p>\n<p>This approach allows for a comprehensive evaluation of clinical trials in all their phases with a multidisciplinary and evidence-based perspective.<\/p>\n<p>We intervene in the preparation of expert reports in situations that require a high degree of specialization, including:<\/p>\n<p>&#8221; content_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.27.5&#8243; _module_preset=&#8221;default&#8221; text_text_color=&#8221;#4C565C&#8221; text_font_size=&#8221;16px&#8221; text_line_height=&#8221;1.5em&#8221; custom_padding=&#8221;|170px||170px|false|true&#8221; custom_padding_tablet=&#8221;|0px||0px|false|true&#8221; custom_padding_phone=&#8221;|0px||0px|false|true&#8221; custom_padding_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p style=\"text-align: center;\">Clinical trials constitute the fundamental pillar of the development of new treatments, allowing for the evaluation of their safety, efficacy, and applicability in humans under a highly demanding regulatory framework.<\/p>\n<p style=\"text-align: center;\">They are structured into different phases\u2014from the first administration in humans (Phase I) to evaluation in real clinical practice (Phase IV)\u2014each with specific scientific objectives and ethical requirements. The correct execution of these phases is critical both for the validity of the results and for the protection of participants. <\/p>\n<p style=\"text-align: center;\">Our firm offers highly specialized expert advice in the field of clinical research, providing independent, rigorous, and technically sound analyses in judicial and extrajudicial proceedings.<\/p>\n<p style=\"text-align: center;\">The reports are prepared by professionals who actively participate in conducting clinical trials, which provides direct and up-to-date knowledge of real clinical practice, as well as a deep understanding of the methodological, regulatory, and ethical aspects involved.<\/p>\n<p style=\"text-align: center;\">This approach allows for a comprehensive evaluation of clinical trials in all their phases with a multidisciplinary and evidence-based perspective.<\/p>\n<p style=\"text-align: center;\">We intervene in the preparation of expert reports in situations that require a high degree of specialization, including:<\/p>\n<p>[\/et_pb_text][et_pb_text content_tablet=&#8221;<\/p>\n<ul>\n<li>Expert evaluation of the methodological quality and scientific validity of the clinical trial, including assessment of the specific drug&apos;s mechanism of action.<\/li>\n<li>Analysis of compliance with current regulations and Good Clinical Practice (GCP), which includes evaluating when a side effect occurs.<\/li>\n<li>Review of the informed consent process and patient safety guarantees.<\/li>\n<li>Assessment of adverse events and causality analysis in relation to the treatment under study.<\/li>\n<li>Evaluation of the performance of investigators, sponsors, CROs, and participating centers.<\/li>\n<li>Analysis of the causal relationship of the alleged adverse effect with the medicine or medical device subjected to the clinical trial.<\/li>\n<\/ul>\n<p>&#8221; content_phone=&#8221;<\/p>\n<ul>\n<li>Expert evaluation of the methodological quality and scientific validity of the clinical trial, including assessment of the specific drug&apos;s mechanism of action.<\/li>\n<li>Analysis of compliance with current regulations and Good Clinical Practice (GCP), which includes evaluating when a side effect occurs.<\/li>\n<li>Review of the informed consent process and patient safety guarantees.<\/li>\n<li>Assessment of adverse events and causality analysis in relation to the treatment under study.<\/li>\n<li>Evaluation of the performance of investigators, sponsors, CROs, and participating centers.<\/li>\n<li>Analysis of the causal relationship of the alleged adverse effect with the medicine or medical device subjected to the clinical trial.<\/li>\n<\/ul>\n<p>&#8221; content_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.27.5&#8243; _module_preset=&#8221;default&#8221; text_text_color=&#8221;#4C565C&#8221; text_font_size=&#8221;16px&#8221; text_line_height=&#8221;1.5em&#8221; custom_padding=&#8221;|270px||270px|false|true&#8221; custom_padding_tablet=&#8221;|0px||0px|false|true&#8221; custom_padding_phone=&#8221;|0px||0px|false|true&#8221; custom_padding_last_edited=&#8221;on|phone&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<ul>\n<li>Expert evaluation of the methodological quality and scientific validity of the clinical trial, including assessment of the specific drug&#8217;s mechanism of action.<\/li>\n<li>Analysis of compliance with current regulations and Good Clinical Practice (GCP), which includes evaluating when a side effect occurs.<\/li>\n<li>Review of the informed consent process and patient safety guarantees.<\/li>\n<li>Assessment of adverse events and causality analysis in relation to the treatment under study.<\/li>\n<li>Evaluation of the performance of investigators, sponsors, CROs, and participating centers.<\/li>\n<li>Analysis of the causal relationship of the alleged adverse effect with the medicine or medical device subjected to the clinical trial.<\/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;4.27.5&#8243; _module_preset=&#8221;default&#8221; background_color=&#8221;#00638E&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row _builder_version=&#8221;4.27.5&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.27.5&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text content_tablet=&#8221;<\/p>\n<h1 style=%22text-align: center;%22>OUR REPORTS STAND OUT FOR THEIR TECHNICAL PRECISION, ARGUMENTATIVE CLARITY, AND UTILITY IN JUDICIAL PROCEEDINGS, OFFERING EXPERT SUPPORT IN COMPLEX LITIGATION RELATED TO THE FIELD OF CLINICAL RESEARCH*<\/h1>\n<p>&#8221; content_phone=&#8221;<\/p>\n<h1 style=%22text-align: center;%22>OUR REPORTS STAND OUT FOR THEIR TECHNICAL PRECISION, ARGUMENTATIVE CLARITY, AND UTILITY IN JUDICIAL PROCEEDINGS, OFFERING EXPERT SUPPORT IN COMPLEX LITIGATION RELATED TO THE FIELD OF CLINICAL RESEARCH*<\/h1>\n<p>&#8221; content_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.27.5&#8243; _module_preset=&#8221;default&#8221; text_text_color=&#8221;#FFFFFF&#8221; text_font_size=&#8221;24px&#8221; text_line_height=&#8221;1.3em&#8221; header_font=&#8221;|700|||||||&#8221; header_text_color=&#8221;#FFFFFF&#8221; header_line_height=&#8221;1.2em&#8221; text_orientation=&#8221;center&#8221; custom_margin=&#8221;||0px|||&#8221; custom_padding=&#8221;||10px||false|false&#8221; custom_padding_tablet=&#8221;||10px||false|false&#8221; custom_padding_phone=&#8221;||10px||false|false&#8221; custom_padding_last_edited=&#8221;on|desktop&#8221; header_font_size_tablet=&#8221;24px&#8221; header_font_size_phone=&#8221;24px&#8221; header_font_size_last_edited=&#8221;on|phone&#8221; header_2_font_size_tablet=&#8221;&#8221; header_2_font_size_phone=&#8221;&#8221; header_2_font_size_last_edited=&#8221;on|desktop&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h1 style=\"text-align: center;\">OUR REPORTS STAND OUT FOR THEIR TECHNICAL PRECISION, ARGUMENTATIVE CLARITY, AND UTILITY IN JUDICIAL PROCEEDINGS, OFFERING EXPERT SUPPORT IN COMPLEX LITIGATION RELATED TO THE FIELD OF CLINICAL RESEARCH*<\/h1>\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;4.27.5&#8243; _module_preset=&#8221;default&#8221; width=&#8221;100%&#8221; max_width=&#8221;1200px&#8221; module_alignment=&#8221;center&#8221; custom_padding=&#8221;||100px|||&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_row _builder_version=&#8221;4.27.5&#8243; _module_preset=&#8221;default&#8221; width=&#8221;85%&#8221; width_tablet=&#8221;80%&#8221; width_phone=&#8221;80%&#8221; width_last_edited=&#8221;on|phone&#8221; module_alignment=&#8221;center&#8221; custom_padding=&#8221;||37px|||&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.27.5&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text content_tablet=&#8221;<\/p>\n<p>*According to the Spanish Agency for Medicines and Medical Devices (Last update: December 29, 2025)<\/p>\n<p>&#8221; content_phone=&#8221;<\/p>\n<p>*According to the Spanish Agency for Medicines and Medical Devices (Last update: December 29, 2025)<\/p>\n<p>&#8221; content_last_edited=&#8221;on|desktop&#8221; _builder_version=&#8221;4.27.5&#8243; _module_preset=&#8221;default&#8221; text_text_color=&#8221;#4C565C&#8221; text_font_size=&#8221;16px&#8221; text_line_height=&#8221;1.5em&#8221; custom_margin=&#8221;||80px|||&#8221; custom_padding=&#8221;|170px||170px|false|true&#8221; custom_padding_tablet=&#8221;|0px||0px|false|true&#8221; custom_padding_phone=&#8221;|0px||0px|false|true&#8221; custom_padding_last_edited=&#8221;on|phone&#8221; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p style=\"text-align: center;\">*According to the Spanish Agency for Medicines and Medical Devices (Last update: December 29, 2025)<\/p>\n<p>[\/et_pb_text][et_pb_text content_tablet=&#8221;<\/p>\n<h2 style=%22text-align: left;%22>CLINICAL TRIALS WITH MEDICINES FOR HUMAN USE<\/h2>\n<p>&#8221; content_phone=&#8221;<\/p>\n<h2 style=%22text-align: left;%22>CLINICAL TRIALS WITH MEDICINES FOR HUMAN USE<\/h2>\n<p>&#8221; content_last_edited=&#8221;on|desktop&#8221; _builder_version=&#8221;4.27.5&#8243; _module_preset=&#8221;default&#8221; text_text_color=&#8221;#00638E&#8221; text_font_size=&#8221;24px&#8221; text_line_height=&#8221;1.3em&#8221; header_font=&#8221;|700|||||||&#8221; header_text_color=&#8221;#00638E&#8221; header_line_height=&#8221;1.2em&#8221; header_2_line_height=&#8221;1.3em&#8221; text_orientation=&#8221;center&#8221; custom_margin=&#8221;||0px|||&#8221; custom_padding=&#8221;40px|120px|10px|120px|false|true&#8221; custom_padding_tablet=&#8221;|0px|10px|0px|false|true&#8221; custom_padding_phone=&#8221;||10px||false|false&#8221; custom_padding_last_edited=&#8221;on|desktop&#8221; header_font_size_tablet=&#8221;24px&#8221; header_font_size_phone=&#8221;24px&#8221; header_font_size_last_edited=&#8221;on|phone&#8221; header_2_font_size_tablet=&#8221;&#8221; header_2_font_size_phone=&#8221;&#8221; header_2_font_size_last_edited=&#8221;on|tablet&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h2 style=\"text-align: center;\">CLINICAL TRIALS WITH MEDICINES FOR HUMAN USE<\/h2>\n<p>[\/et_pb_text][et_pb_text content_tablet=&#8221;<\/p>\n<p>A clinical trial with medicines is research conducted on people, intended to study the efficacy and safety of a drug. The objective of these studies is to obtain data confirming that the benefit\/risk balance is positive for a given therapy, in order to subsequently request marketing authorization for the medicine. <\/p>\n<p>Clinical research goes through several phases, in which the study populations progressively increase:<\/p>\n<p>&#8221; content_phone=&#8221;<\/p>\n<p>A clinical trial with medicines is research conducted on people, intended to study the efficacy and safety of a drug. The objective of these studies is to obtain data confirming that the benefit\/risk balance is positive for a given therapy, in order to subsequently request marketing authorization for the medicine. <\/p>\n<p>Clinical research goes through several phases, in which the study populations progressively increase:<\/p>\n<p>&#8221; content_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.27.5&#8243; _module_preset=&#8221;default&#8221; text_text_color=&#8221;#4C565C&#8221; text_font_size=&#8221;16px&#8221; text_line_height=&#8221;1.5em&#8221; custom_padding=&#8221;|170px||170px|false|true&#8221; custom_padding_tablet=&#8221;|0px||0px|false|true&#8221; custom_padding_phone=&#8221;|0px||0px|false|true&#8221; custom_padding_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p style=\"text-align: center;\">A clinical trial with medicines is research conducted on people, intended to study the efficacy and safety of a drug. The objective of these studies is to obtain data confirming that the benefit\/risk balance is positive for a given therapy, in order to subsequently request marketing authorization for the medicine. <\/p>\n<p style=\"text-align: center;\">Clinical research goes through several phases, in which the study populations progressively increase:<\/p>\n<p>[\/et_pb_text][et_pb_text content_tablet=&#8221;<\/p>\n<ul>\n<li><strong>Phase I:<\/strong> few participants (dozens), who may be healthy volunteers depending on the pathology under study, to confirm that the administration of the drug is safe.<\/li>\n<li><strong>Phase II:<\/strong> efficacy analyses begin in a population that can reach 200-300 people, with safety at the explored doses being another primary objective.<\/li>\n<li><strong>Phase III:<\/strong> confirmation of the drug&apos;s efficacy in thousands of participants with the aim of obtaining data for a marketing authorization application.<\/li>\n<li><strong>Phase IV:<\/strong> long-term studies with already authorized medicines to study rare adverse reactions or identify potential additional benefits.<\/li>\n<\/ul>\n<p>&#8221; content_phone=&#8221;<\/p>\n<ul>\n<li><strong>Phase I:<\/strong> few participants (dozens), who may be healthy volunteers depending on the pathology under study, to confirm that the administration of the drug is safe.<\/li>\n<li><strong>Phase II:<\/strong> efficacy analyses begin in a population that can reach 200-300 people, with safety at the explored doses being another primary objective.<\/li>\n<li><strong>Phase III:<\/strong> confirmation of the drug&apos;s efficacy in thousands of participants with the aim of obtaining data for a marketing authorization application.<\/li>\n<li><strong>Phase IV:<\/strong> long-term studies with already authorized medicines to study rare adverse reactions or identify potential additional benefits.<\/li>\n<\/ul>\n<p>&#8221; content_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.27.5&#8243; _module_preset=&#8221;default&#8221; text_text_color=&#8221;#4C565C&#8221; text_font_size=&#8221;16px&#8221; text_line_height=&#8221;1.5em&#8221; custom_padding=&#8221;|270px||270px|false|true&#8221; custom_padding_tablet=&#8221;|0px||0px|false|true&#8221; custom_padding_phone=&#8221;|0px||0px|false|true&#8221; custom_padding_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<ul>\n<li><strong>Phase I:<\/strong> few participants (dozens), who may be healthy volunteers depending on the pathology under study, to confirm that the administration of the drug is safe.<\/li>\n<li><strong>Phase II:<\/strong> efficacy analyses begin in a population that can reach 200-300 people, with safety at the explored doses being another primary objective.<\/li>\n<li><strong>Phase III:<\/strong> confirmation of the drug&#8217;s efficacy in thousands of participants with the aim of obtaining data for a marketing authorization application.<\/li>\n<li><strong>Phase IV:<\/strong> long-term studies with already authorized medicines to study rare adverse reactions or identify potential additional benefits.<\/li>\n<\/ul>\n<p>[\/et_pb_text][et_pb_text content_tablet=&#8221;<\/p>\n<p>The <strong><a href=%22https:\/\/www.aemps.gob.es\/%22 data-et-target-link=%22_blank%22 rel=%22noopener%22>AEMPS<\/a><\/strong> is the competent authority in Spain for issuing authorization for clinical trials with medicines. However, it should be noted that the review of the different scientific-ethical aspects of the study is carried out in a coordinated manner between the AEMPS and the Ethics Committees (CEIm). <\/p>\n<p>&#8221; content_phone=&#8221;<\/p>\n<p>The <strong><a href=%22https:\/\/www.aemps.gob.es\/%22 data-et-target-link=%22_blank%22 rel=%22noopener%22>AEMPS<\/a><\/strong> is the competent authority in Spain for issuing authorization for clinical trials with medicines. However, it should be noted that the review of the different scientific-ethical aspects of the study is carried out in a coordinated manner between the AEMPS and the Ethics Committees (CEIm). <\/p>\n<p>&#8221; content_last_edited=&#8221;on|phone&#8221; _builder_version=&#8221;4.27.5&#8243; _module_preset=&#8221;default&#8221; text_text_color=&#8221;#4C565C&#8221; text_font_size=&#8221;16px&#8221; text_line_height=&#8221;1.5em&#8221; custom_padding=&#8221;|170px||170px|false|true&#8221; custom_padding_tablet=&#8221;|0px||0px|false|true&#8221; custom_padding_phone=&#8221;|0px||0px|false|true&#8221; custom_padding_last_edited=&#8221;on|phone&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<p style=\"text-align: center;\">The <strong><a href=\"https:\/\/www.aemps.gob.es\/\" target=\"_blank\" rel=\"noopener\">AEMPS<\/a><\/strong> is the competent authority in Spain for issuing authorization for clinical trials with medicines. However, it should be noted that the review of the different scientific-ethical aspects of the study is carried out in a coordinated manner between the AEMPS and the Ethics Committees (CEIm). <\/p>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Expert Medical Opinionin Clinical TrialsEXPERT MEDICAL OPINION IN CLINICAL TRIALS WITH MEDICINES AND MEDICAL DEVICES FOR HUMAN USEClinical trials constitute the fundamental pillar of the development of new treatments, allowing for the evaluation of their safety, efficacy, and applicability in humans under a highly demanding regulatory framework. They are structured into different phases\u2014from the first [&hellip;]<\/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":"","footnotes":""},"class_list":["post-1018","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Clinical Trials - CRITERIA M\u00c9DICA<\/title>\n<meta name=\"description\" content=\"Criteria M\u00e9dica provides highly specialized expert advice in the field of clinical research.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/criteriamedica.com\/en\/clinical-trials\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Clinical Trials - 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