\ube44\uc784\uc0c1-\uc784\uc0c1 \ud1b5\ud569 \uac00\uad50 \uc804\ub7b5: \uacfc\ud559\uc801 \uc5f0\uc18d\uc131 \ubc0f \uaddc\uc81c \uc815\ud569\uc131 \ud655\ubcf4\ub97c \uc704\ud55c \uc911\uac1c \uc5f0\uad6c \uc804\ub7b5 \uc218\ub9bd<\/li>\n<\/ul>\n <\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row type=”full_width_background” full_screen_row_position=”middle” column_margin=”default” column_direction=”default” column_direction_tablet=”default” column_direction_phone=”default” bg_color=”#ffffff” scene_position=”center” left_padding_desktop=”10%” constrain_group_2=”yes” right_padding_desktop=”10%” top_padding_tablet=”8%” constrain_group_3=”yes” bottom_padding_tablet=”8%” left_padding_tablet=”3%” constrain_group_4=”yes” right_padding_tablet=”3%” left_padding_phone=”0″ constrain_group_6=”yes” right_padding_phone=”0″ text_color=”dark” text_align=”left” row_border_radius=”none” row_border_radius_applies=”bg” overflow=”visible” id=”PK-PD” overlay_strength=”0.3″ gradient_direction=”left_to_right” shape_divider_position=”bottom” bg_image_animation=”none” shape_type=”” gradient_type=”default”][vc_column column_padding=”no-extra-padding” column_padding_tablet=”inherit” column_padding_phone=”inherit” column_padding_position=”all” column_element_direction_desktop=”default” column_element_spacing=”default” desktop_text_alignment=”default” tablet_text_alignment=”default” phone_text_alignment=”default” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_backdrop_filter=”none” column_shadow=”none” column_border_radius=”none” column_link_target=”_self” column_position=”default” gradient_direction=”left_to_right” overlay_strength=”0.3″ width=”1\/1″ tablet_width_inherit=”default” animation_type=”default” bg_image_animation=”none” border_type=”simple” column_border_width=”none” column_border_style=”solid”][divider line_type=”Full Width Line” line_thickness=”1″ divider_color=”accent-color” custom_height=”100″][vc_row_inner column_margin=”60px” column_direction=”default” column_direction_tablet=”default” column_direction_phone=”default” text_align=”left” row_position=”default” row_position_tablet=”inherit” row_position_phone=”inherit” overflow=”visible” pointer_events=”all”][vc_column_inner column_padding=”padding-4-percent” column_padding_tablet=”no-extra-padding” column_padding_phone=”no-extra-padding” column_padding_position=”all” column_element_direction_desktop=”default” column_element_spacing=”default” desktop_text_alignment=”default” tablet_text_alignment=”default” phone_text_alignment=”default” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_backdrop_filter=”none” column_shadow=”none” column_border_radius=”none” column_link_target=”_self” overflow=”visible” gradient_direction=”left_to_right” overlay_strength=”0.3″ width=”1\/1″ tablet_width_inherit=”default” animation_type=”default” enable_animation=”true” animation=”fade-in-from-bottom” animation_easing=”default” bg_image_animation=”none” border_type=”simple” column_border_width=”none” column_border_style=”solid” column_padding_type=”default” gradient_type=”default” delay=”400″][split_line_heading animation_type=”line-reveal-by-space” font_style=”h2″ line_reveal_by_space_text_effect=”default” stagger_animation=”true” content_alignment=”default” mobile_content_alignment=”inherit” link_target=”_self” text_content=”PK\/PD Modeling & Simulation (M&S)” font_line_height=”1.3″ text_direction=”default” font_size=”55″][\/split_line_heading][nectar_responsive_text inherited_font_style=”h4″ font_size_desktop=”28″ font_line_height=”1.3″ text_direction=”default” font_size_phone=”24″]\uc57d\ub3d9\ud559\/\uc57d\ub825\ud559 \ubaa8\ub378\ub9c1 \ubc0f \uc2dc\ubbac\ub808\uc774\uc158(M&S) \uae30\ubc18 \uc784\uc0c1 \uc804\ub7b5 \ucd5c\uc801\ud654[\/nectar_responsive_text][nectar_responsive_text inherited_font_style=”p” font_size_desktop=”19″ font_line_height=”1.3″ text_direction=”default”]\nPK\/PD \ubaa8\ub378\ub9c1 \ubc0f \uc2dc\ubbac\ub808\uc774\uc158(M&S)\uc740 \ubaa8\ub378 \uae30\ubc18 \uc2e0\uc57d\uac1c\ubc1c(MIDD, Model-Informed Drug Development)\uc758 \ud575\uc2ec \ubc29\ubc95\ub860\uc73c\ub85c, \uc6a9\ub7c9-\ub178\ucd9c-\ubc18\uc751 \uad00\uacc4\ub97c \uc815\ub7c9\uc801\uc73c\ub85c \ud3c9\uac00\ud568\uc73c\ub85c\uc368 \uc784\uc0c1\uc2dc\ud5d8\uc758 \ubd88\ud655\uc2e4\uc131\uc744 \uac10\uc18c\uc2dc\ud0a4\uace0, \ucd5c\uc801 \uc6a9\ub7c9 \uc120\uc815\uc744 \uc9c0\uc6d0\ud558\uba70, \uae30\uc220\uc801 \uc131\uacf5 \uac00\ub2a5\uc131(pTS) \ubc0f \uc784\uc0c1\uc801 \uc131\uacf5 \uac00\ub2a5\uc131\uc744 \uc81c\uace0\ud569\ub2c8\ub2e4.<\/p>\n
\ube44\uc5d1\uc2a4\ud50c\ub79c\ud2b8\uc758 \ud1b5\ud569 PK\/PD M&S \ud50c\ub7ab\ud3fc\uc740 \ube44\uc784\uc0c1 \ud6c4\ubcf4\ubb3c\uc9c8 \ubc1c\uad74 \ub2e8\uacc4\ubd80\ud130 \uc784\uc0c1\uc801 \uac1c\ub150\uc99d\uba85(POC)\uc5d0 \uc774\ub974\ub294 \uc911\uac1c \uc5f0\uad6c\uc758 \uac04\uadf9\uc744 \ud6a8\uacfc\uc801\uc73c\ub85c \uc5f0\uacb0\ud569\ub2c8\ub2e4. \uc2dc\ud5d8\uad00 \ub0b4(in vitro) \ubc0f \uc0dd\uccb4 \ub0b4(in vivo) \ube44\uc784\uc0c1 \ub370\uc774\ud130\ub97c \uc0dd\ub9ac\ud559\uc801 \uc57d\ub3d9\ud559(PBPK) \ubaa8\ub378\ub9c1, \uc815\ub7c9\uc801 \uc2dc\uc2a4\ud15c \uc57d\ub9ac\ud559(QSP), \uc9d1\ub2e8 PK\/PD \ubd84\uc11d, AI \uae30\ubc18 \uc2dc\ubbac\ub808\uc774\uc158 \ub4f1 \uae30\uacc4\ub860\uc801\u00b7\uacbd\ud5d8\uc801 \ubaa8\ub378\ub9c1 \uae30\ubc95\uacfc \ud1b5\ud569\ud558\uc5ec, \ucd5c\ucd08 \uc778\uccb4 \ud22c\uc5ec(FIH) \uc774\uc804 \ub2e8\uacc4\uc5d0\uc11c \uc778\uccb4 \uc57d\ub3d9\ud559(PK), \uc57d\ub825\ud559(PD), \uc720\ud6a8\uc131 \ubc0f \uc548\uc804\uc131\uc5d0 \ub300\ud55c \uace0\uc2e0\ub8b0\ub3c4 \uc608\uce21\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4. ICH E4, FDA MIDD \uac00\uc774\ub358\uc2a4, EMA \ubaa8\ub378\ub9c1 \ubc0f \uc2dc\ubbac\ub808\uc774\uc158 \ud504\ub808\uc784\uc6cc\ud06c\uc5d0 \ubd80\ud569\ud558\ub294 \ubaa9\uc801 \uc801\ud569\ud615(fit-for-purpose) \ubaa8\ub378\ub9c1 \uc804\ub7b5\uc744 \uc804\uccb4 \uac1c\ubc1c \uc0dd\uc560\uc8fc\uae30\uc5d0 \uac78\uccd0 \uc801\uc6a9\ud568\uc73c\ub85c\uc368, \uc758\uc0ac\uacb0\uc815\uc744 \uac00\uc18d\ud654\ud558\uace0 \uc784\uc0c1\uc2dc\ud5d8 \uc2e4\ud328\ub97c \ucd5c\uc18c\ud654\ud558\uba70 \uac1c\ubc1c \ud3ec\ud2b8\ud3f4\ub9ac\uc624\uc758 \uac00\uce58\ub97c \uadf9\ub300\ud654\ud569\ub2c8\ub2e4.<\/p>\n
Preclinical to Clinical Translation<\/strong><\/p>\n\u25b8\uc778\uccb4\uc5d0\uc11c \uc57d\ub3d9\ud559 \uc608\uce21\uc744 \uc704\ud55c Allometric Scaling \ubc0f PBPK \ubaa8\ub378\ub9c1<\/p>\n
\u25b8\ucd5c\uc18c\uc608\uc0c1\uc0dd\ubb3c\ud559\uc801\ud6a8\uacfc\uc6a9\ub7c9(MABEL) \ubc0f \ucd5c\ub300\uad8c\uc7a5\uc2dc\uc791\uc6a9\ub7c9(MRSD) \uc0b0\ucd9c<\/p>\n
\u25b8\ube44\uc784\uc0c1 \uc720\ud6a8\uc131 \ubc0f \uc548\uc804\uc131 \ub9c8\uc9c4\uc744 \ud65c\uc6a9\ud55c \uc778\uccb4 \ud22c\uc5ec \uc6a9\ub7c9 \uc608\uce21<\/p>\n
Clinical Trial Optimization<\/strong><\/p>\n\u25b8\ud45c\ubcf8 \uc218 \uc0b0\ucd9c \ubc0f \uc801\uc751\uc801 \uc124\uacc4\ub97c \uc704\ud55c \uac00\uc0c1 \uc784\uc0c1\uc2dc\ud5d8 \uc2dc\ubbac\ub808\uc774\uc158<\/p>\n
\u25b8\uc6a9\ub7c9 \ubc94\uc704 \ud0d0\uc0c9 \uc5f0\uad6c \ucd5c\uc801\ud654 \ubc0f \ub178\ucd9c-\ubc18\uc751 \ubaa8\ub378\ub9c1<\/p>\n
\u25b8\ud2b9\uc218 \uc9d1\ub2e8(\uc18c\uc544, \uc2e0\uc7a5\/\uac04 \uae30\ub2a5 \uc7a5\uc560, \uc57d\ubb3c\uc0c1\ud638\uc791\uc6a9) \ub300\uc0c1 \uacf5\ubcc0\ub7c9 \ubd84\uc11d<\/p>\n
Regulatory Strategy & Submissions<\/strong><\/p>\n\u25b8\uacbd\uc7c1 \ud658\uacbd \ud3c9\uac00\ub97c \uc704\ud55c Model-Based Meta-Analysis<\/p>\n
\u25b8FDA, EMA, \uc2dd\uc57d\ucc98(MFDS) \uac00\uc774\ub358\uc2a4\uc5d0 \ubd80\ud569\ud558\ub294 \ud1b5\ud569 \uc548\uc804\uc131\u00b7\uc720\ud6a8\uc131 \ubd84\uc11d<\/p>\n
\u25b8Clinical Pharmacology briefing package \ubc0f 2\uc0c1 \uc885\ub8cc \ubbf8\ud305(End-of-Phase 2 Meeting) \uc900\ube44 \uc9c0\uc6d0<\/p>\n
Post-Approval Lifecycle Management<\/strong><\/p>\n\u25b8\uc2e0\uaddc \uc801\uc751\uc99d \ubc0f \ud658\uc790\uad70 \ud655\ub300\ub97c \uc704\ud55c \ub77c\ubca8 \ud655\uc7a5 \ubaa8\ub378\ub9c1<\/p>\n
\u25b8\uc9d1\ub2e8 PK\/PD \ud504\ub808\uc784\uc6cc\ud06c\uc640 \uc2e4\uc0ac\uc6a9\uc99d\uac70(RWE) \ud1b5\ud569 \ubd84\uc11d<\/p>\n
\u25b8\uc2dc\ud310 \ud6c4 \uc870\uac74\ubd80 \uc774\ud589(Post-Marketing Commitment) \uc9c0\uc6d0\uc744 \uc704\ud55c \uacc4\ub7c9\uc57d\ub9ac\ud559 \ubd84\uc11d[\/nectar_responsive_text][nectar_badge display_tag=”h6″ badge_style=”default” bg_color_type=”global” color=”extra-color-2″ text_color=”#ffffff” padding=”small” border_radius=”20px” display=”block” text=”Modeling & Simulation Services”]
\n
\n- Physiologically Based Pharmacokinetic (PBPK) Modeling<\/strong>
\n– \ucd5c\ucd08 \uc778\uccb4 \ud22c\uc5ec(FIH) \uc6a9\ub7c9 \uc120\uc815, \uc57d\ubb3c\uc0c1\ud638\uc791\uc6a9(DDI) \uc608\uce21 \ubc0f \uba74\uc81c \uc804\ub7b5, \ud2b9\uc218 \uc9d1\ub2e8 \ubd84\uc11d<\/li>\n- PK\/PD & Quantitative Systems Pharmacology (QSP)<\/strong>
\n– \uc720\ud6a8\uc131 \ubc0f \ud45c\uc801 \uacb0\ud569(Target Engagement) \ud3c9\uac00, \uc911\uac1c \uc5f0\uad6c \ubaa8\ub378\ub9c1<\/li>\n- Biopharmaceutics & IVIVC (In Vitro-In Vivo Correlation)<\/strong>
\n– \uc0dd\ubb3c\ud559\uc801 \ub3d9\ub4f1\uc131 \uba74\uc81c(Biowaiver) \uc9c0\uc6d0, \uc81c\ud615 \ucd5c\uc801\ud654<\/li>\n<\/ul>\n <\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row type=”full_width_background” full_screen_row_position=”middle” column_margin=”default” column_direction=”default” column_direction_tablet=”default” column_direction_phone=”default” bg_color=”#ffffff” scene_position=”center” left_padding_desktop=”10%” constrain_group_2=”yes” right_padding_desktop=”10%” top_padding_tablet=”8%” constrain_group_3=”yes” bottom_padding_tablet=”8%” left_padding_tablet=”3%” constrain_group_4=”yes” right_padding_tablet=”3%” left_padding_phone=”0″ constrain_group_6=”yes” right_padding_phone=”0″ text_color=”dark” text_align=”left” row_border_radius=”none” row_border_radius_applies=”bg” overflow=”visible” id=”clinical-strategy” overlay_strength=”0.3″ gradient_direction=”left_to_right” shape_divider_position=”bottom” bg_image_animation=”none” shape_type=”” gradient_type=”default”][vc_column column_padding=”no-extra-padding” column_padding_tablet=”inherit” column_padding_phone=”inherit” column_padding_position=”all” column_element_direction_desktop=”default” column_element_spacing=”default” desktop_text_alignment=”default” tablet_text_alignment=”default” phone_text_alignment=”default” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_backdrop_filter=”none” column_shadow=”none” column_border_radius=”none” column_link_target=”_self” column_position=”default” gradient_direction=”left_to_right” overlay_strength=”0.3″ width=”1\/1″ tablet_width_inherit=”default” animation_type=”default” bg_image_animation=”none” border_type=”simple” column_border_width=”none” column_border_style=”solid”][divider line_type=”Full Width Line” line_thickness=”1″ divider_color=”accent-color” custom_height=”100″][vc_row_inner column_margin=”60px” column_direction=”default” column_direction_tablet=”default” column_direction_phone=”default” text_align=”left” row_position=”default” row_position_tablet=”inherit” row_position_phone=”inherit” overflow=”visible” pointer_events=”all”][vc_column_inner column_padding=”padding-4-percent” column_padding_tablet=”no-extra-padding” column_padding_phone=”no-extra-padding” column_padding_position=”all” column_element_direction_desktop=”default” column_element_spacing=”default” desktop_text_alignment=”default” tablet_text_alignment=”default” phone_text_alignment=”default” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_backdrop_filter=”none” column_shadow=”none” column_border_radius=”none” column_link_target=”_self” overflow=”visible” gradient_direction=”left_to_right” overlay_strength=”0.3″ width=”1\/1″ tablet_width_inherit=”default” animation_type=”default” enable_animation=”true” animation=”fade-in-from-bottom” animation_easing=”default” bg_image_animation=”none” border_type=”simple” column_border_width=”none” column_border_style=”solid” column_padding_type=”default” gradient_type=”default” delay=”400″][split_line_heading animation_type=”line-reveal-by-space” font_style=”h2″ line_reveal_by_space_text_effect=”default” stagger_animation=”true” content_alignment=”default” mobile_content_alignment=”inherit” link_target=”_self” text_content=”Clinical Strategy & Consulting” font_line_height=”1.3″ text_direction=”default” font_size=”55″][\/split_line_heading][nectar_responsive_text inherited_font_style=”h4″ font_size_desktop=”28″ font_line_height=”1.3″ text_direction=”default” font_size_phone=”24″]\uac1c\ubc1c \uc804\ub7b5 \ucd5c\uc801\ud654\ub97c \ud1b5\ud55c \uc784\uc0c1 \uc131\uacf5 \uac00\ub2a5\uc131 \uadf9\ub300\ud654[\/nectar_responsive_text][nectar_responsive_text inherited_font_style=”p” font_size_desktop=”19″ font_line_height=”1.3″ text_direction=”default”]\uc784\uc0c1\uac1c\ubc1c\uc758 \uc131\uacf5 \uc5ec\ubd80\ub294 \uc804\ub7b5\uc758 \uc815\uad50\ud568\uc5d0\uc11c \uacb0\uc815\ub429\ub2c8\ub2e4. \uacfc\ud559\uc801 \ud0c0\ub2f9\uc131\uacfc \uaddc\uc81c \uc2b9\uc778 \uac00\ub2a5\uc131\uc744 \ub3d9\uc2dc\uc5d0 \ucda9\uc871\uc2dc\ud0a4\ub294 \uc124\uacc4\ub294 \uc784\uc0c1 \uae30\uac04 \ub2e8\ucd95, \ube44\uc6a9 \uc808\uac10, \uc2e4\ud328 \ub9ac\uc2a4\ud06c \ucd5c\uc18c\ud654\ub85c \uc774\uc5b4\uc9d1\ub2c8\ub2e4.
\nBXPLANT\ub294 TPP(Target Product Profile) \uc124\uc815\ubd80\ud130 \uc784\uc0c1\uc2dc\ud5d8 \uc124\uacc4, \uaddc\uc81c \uacbd\ub85c, \uc2dc\uc7a5 \uc9c4\uc785 \uc804\ub7b5\uae4c\uc9c0 \uc804 \uc8fc\uae30\uc5d0 \uac78\uccd0 \uac1c\ubc1c \uac00\uce58\ub97c \uadf9\ub300\ud654\ud558\ub294 \ub9de\ucda4\ud615 \uc804\ub7b5 \ucee8\uc124\ud305\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4.[\/nectar_responsive_text][nectar_badge display_tag=”h6″ badge_style=”default” bg_color_type=”global” color=”extra-color-2″ text_color=”#ffffff” padding=”small” border_radius=”20px” display=”block” text=”Clinical Strategy & Consulting Services”] \n
\n- Development strategy formulation:<\/strong> \ubaa9\ud45c \uc81c\ud488 \ud504\ub85c\ud30c\uc77c(TPP) \ubc0f \uc784\uc0c1 \uac1c\ubc1c \uacc4\ud68d(CDP) \uc218\ub9bd, \uc801\uc751\uc99d \uc120\uc815, \uacbd\uc7c1\uc801 \ucc28\ubcc4\ud654 \uc804\ub7b5 \ubc0f \uc0dd\uc560\uc8fc\uae30 \uacc4\ud68d \uc218\ub9bd<\/li>\n
- Clinical program architecture:<\/strong> \uc784\uc0c1 \ub2e8\uacc4\ubcc4 \uc801\ud569\ud55c \uc2dc\ud5d8 \uc124\uacc4, \ud3c9\uac00\ubcc0\uc218(Endpoint) \uc120\uc815, \ubaa9\ud45c \ud658\uc790\uad70 \uc815\uc758 \ubc0f \uc801\uc751\uc801 \uc784\uc0c1\uc2dc\ud5d8(Adaptive Trial) \uc804\ub7b5 \uc218\ub9bd<\/li>\n
- Gap analysis and risk mitigation:<\/strong> \ube44\uc784\uc0c1-\uc784\uc0c1 \uc911\uac1c \uc5f0\uad6c \ud3c9\uac00, \ub370\uc774\ud130 \ucda9\uc871\uc131 \uac80\ud1a0 \ubc0f \uaddc\uc81c\uc801 \uc704\ud5d8 \uc694\uc18c \uc2dd\ubcc4<\/li>\n
- Regulatory pathway optimization:<\/strong> IND\/CTA \uc804\ub7b5 \uc218\ub9bd, \uc2e0\uc18d\uc2ec\uc0ac(Breakthrough\/Expedited) \uc9c0\uc815 \uac00\ub2a5\uc131 \uac80\ud1a0, \uaddc\uc81c\uae30\uad00 \ub300\uc751 \uacc4\ud68d \ubc0f \ud5c8\uac00 \uc77c\uc815 \ub2e8\ucd95 \uc804\ub7b5<\/li>\n
- Market access and commercialization strategy:<\/strong> \ubcf4\uac74\uacbd\uc81c\uc131(HEOR) \uadfc\uac70 \uacc4\ud68d \uc218\ub9bd, \uae09\uc5ec \ub4f1\uc7ac \uacbd\ub85c \uac80\ud1a0 \ubc0f \uacbd\uc7c1\ub825 \ud655\ubcf4\ub97c \uc704\ud55c \ud5c8\uac00\uc0ac\ud56d(Label) \ucd5c\uc801\ud654 \uc804\ub7b5<\/li>\n<\/ul>\n <\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row][vc_row type=”full_width_background” full_screen_row_position=”middle” column_margin=”default” column_direction=”default” column_direction_tablet=”default” column_direction_phone=”default” bg_color=”#ffffff” scene_position=”center” bottom_padding=”5%” left_padding_desktop=”10%” constrain_group_2=”yes” right_padding_desktop=”10%” top_padding_tablet=”8%” constrain_group_3=”yes” bottom_padding_tablet=”8%” left_padding_tablet=”3%” constrain_group_4=”yes” right_padding_tablet=”3%” left_padding_phone=”0″ constrain_group_6=”yes” right_padding_phone=”0″ text_color=”dark” text_align=”left” row_border_radius=”none” row_border_radius_applies=”bg” overflow=”visible” id=”CPL” overlay_strength=”0.3″ gradient_direction=”left_to_right” shape_divider_position=”bottom” bg_image_animation=”none” shape_type=”” gradient_type=”default”][vc_column column_padding=”no-extra-padding” column_padding_tablet=”inherit” column_padding_phone=”inherit” column_padding_position=”all” column_element_direction_desktop=”default” column_element_spacing=”default” desktop_text_alignment=”default” tablet_text_alignment=”default” phone_text_alignment=”default” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_backdrop_filter=”none” column_shadow=”none” column_border_radius=”none” column_link_target=”_self” column_position=”default” gradient_direction=”left_to_right” overlay_strength=”0.3″ width=”1\/1″ tablet_width_inherit=”default” animation_type=”default” bg_image_animation=”none” border_type=”simple” column_border_width=”none” column_border_style=”solid”][divider line_type=”Full Width Line” line_thickness=”1″ divider_color=”accent-color” custom_height=”100″][vc_row_inner column_margin=”60px” column_direction=”default” column_direction_tablet=”default” column_direction_phone=”default” text_align=”left” row_position=”default” row_position_tablet=”inherit” row_position_phone=”inherit” overflow=”visible” pointer_events=”all”][vc_column_inner column_padding=”padding-4-percent” column_padding_tablet=”no-extra-padding” column_padding_phone=”no-extra-padding” column_padding_position=”all” column_element_direction_desktop=”default” column_element_spacing=”default” desktop_text_alignment=”default” tablet_text_alignment=”default” phone_text_alignment=”default” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_backdrop_filter=”none” column_shadow=”none” column_border_radius=”none” column_link_target=”_self” overflow=”visible” gradient_direction=”left_to_right” overlay_strength=”0.3″ width=”1\/1″ tablet_width_inherit=”default” animation_type=”default” enable_animation=”true” animation=”fade-in-from-bottom” animation_easing=”default” bg_image_animation=”none” border_type=”simple” column_border_width=”none” column_border_style=”solid” column_padding_type=”default” gradient_type=”default” delay=”400″][split_line_heading animation_type=”line-reveal-by-space” font_style=”h2″ line_reveal_by_space_text_effect=”default” stagger_animation=”true” content_alignment=”default” mobile_content_alignment=”inherit” link_target=”_self” text_content=”Clinical Project Lead (CPL) Services” font_line_height=”1.3″ text_direction=”default” font_size=”55″][\/split_line_heading][nectar_responsive_text inherited_font_style=”h4″ font_size_desktop=”28″ font_line_height=”1.3″ text_direction=”default” font_size_phone=”24″]\uc2a4\ud3f0\uc11c\uc758 \ud655\uc7a5\ub41c \uc784\uc0c1 \uc870\uc9c1 \uc5ed\ud560[\/nectar_responsive_text][nectar_responsive_text inherited_font_style=”p” font_size_desktop=”19″ font_line_height=”1.3″ text_direction=”default”]CPL\uc740 \uc758\uc0ac\uacb0\uc815\uacfc \ud604\uc7a5 \uc2e4\ud589\uc744 \uc5f0\uacb0\ud558\ub294 \u201c\uc784\uc0c1 \ub9ac\ub354\uc2ed\uc758 \uc911\uc2ec\ucd95\u201d\uc785\ub2c8\ub2e4.
\nBXPLANT\uc758 CPL \uc11c\ube44\uc2a4\ub294 \uc2a4\ud3f0\uc11c\uc758 \ub0b4\ubd80 \uc784\uc0c1 \ubd80\uc11c\ucc98\ub7fc \uae30\ub2a5\ud558\uba70, \ud504\ub85c\uc81d\ud2b8\uc758 \ubaa9\ud45c\u00b7\uc77c\uc815\u00b7\uc608\uc0b0\u00b7\ud488\uc9c8\uc744 \ud1b5\ud569\uc801\uc73c\ub85c \uad00\ub9ac\ud558\uc5ec \uc784\uc0c1\uc2dc\ud5d8 \uc131\uacf5\ub960\uc744 \ub192\uc774\ub294 \ud575\uc2ec \ub9ac\ub354\uc2ed\uc744 \uc81c\uacf5\ud569\ub2c8\ub2e4. \uc6b0\ub9ac\ub294 \uc885\ud569\uc801\uc778 \ud504\ub85c\uc81d\ud2b8 \uc6b4\uc601 \ud1b5\uc81c(oversight)\uc640 CRO \ubc0f \ubca4\ub354\uc640\uc758 \uc6d0\ud65c\ud55c \ucee4\ubba4\ub2c8\ucf00\uc774\uc158\uc744 \ud1b5\ud574 \ud504\ub85c\ud1a0\ucf5c \uc77c\uad00\uc131\uacfc \uc2e4\ud589 \ud488\uc9c8\uc744 \ubcf4\uc7a5\ud569\ub2c8\ub2e4.[\/nectar_responsive_text][nectar_badge display_tag=”h6″ badge_style=”default” bg_color_type=”global” color=”extra-color-2″ text_color=”#ffffff” padding=”small” border_radius=”20px” display=”block” text=”CPL Services”] \n
\n- Virtual clinical team leadership:<\/strong> \uc804\ub7b5\uc801 \ubc29\ud5a5 \uc124\uc815, \ub0b4\/\uc678\ubd80 \uc774\ud574\uad00\uacc4\uc790 \uac04 \uad50\ucc28\uae30\ub2a5\uc801 \uc870\uc815, \uc758\uc0ac\uacb0\uc815 \uad8c\ud55c \ud589\uc0ac \ubc0f \ud300 alignment<\/li>\n
- Vendor and CRO oversight:<\/strong> \uacc4\uc57d \ud611\uc0c1, \uc131\uacfc \ubaa8\ub2c8\ud130\ub9c1, \uc0b0\ucd9c\ubb3c \uac80\ud1a0, issue escalation \ubc0f \ud488\uc9c8 \ubcf4\uc99d<\/li>\n
- Timeline and budget governance:<\/strong> Milestone tracking, \uc790\uc6d0 \ucd5c\uc801\ud654, \uc7ac\ubb34 \uc608\uce21, \uc704\ud5d8 \uc870\uc815 \uacc4\ud68d \uc218\ub9bd \ubc0f \uad00\ub9ac<\/li>\n
- Proactive issue resolution:<\/strong> \uacc4\ud68d \uc774\ud0c8\/\uc704\ubc18 \uad00\ub9ac, \ub300\uc0c1\uc790 \ub4f1\ub85d \ubb38\uc81c \ub300\uc751, \uc5f0\uad6c\uae30\uad00 \uc131\uacfc \ucd5c\uc801\ud654, \uaddc\uc81c\uae30\uad00 \uc9c8\uc758 \ub300\uc751 \ubc0f \uc801\uc751\uc801 \ubb38\uc81c \ud574\uacb0<\/li>\n
- Quality and compliance assurance:<\/strong> GCP \uc900\uc218 \ubaa8\ub2c8\ud130\ub9c1, \uc2e4\uc0ac \ub300\ube44, \uc810\uac80 \uc900\ube44 \ubc0f \ud45c\uc900\uc791\uc5c5\uc9c0\uce68\/\ud45c\uc900\uc6b4\uc601\uc808\ucc28(SOP)\/\uac00\uc774\ub4dc\ub77c\uc778 \uc774\ud589<\/li>\n
- Executive reporting and communication:<\/strong> \uc774\uc0ac\ud68c \ubcf4\uace0, \ud22c\uc790\uc790 \ud504\ub808\uc820\ud14c\uc774\uc158, \ud30c\ud2b8\ub108\uc2ed \ucee4\ubba4\ub2c8\ucf00\uc774\uc158 \ubc0f \uaddc\uc81c\uae30\uad00 \ub300\uc751<\/li>\n<\/ul>\n <\/div>[\/vc_column_inner][\/vc_row_inner][\/vc_column][\/vc_row]\n","protected":false},"excerpt":{"rendered":"
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