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Mastering trial management

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InSIGHT, our clinical trial management system (CTMS), is a powerful web-based, integrated information solution that consolidates, standardizes and visualizes operational and clinical data from multiple sources to generate a holistic view of all study information. InSIGHT allows you to turn your data into real knowledge, supporting better and faster decision-making throughout the life of a trial.

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“More than 20 years of experience distilled in our CTMS: InSIGHT.”

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INSIGHT AT A GLANCE

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With InSIGHT, you have the tools and resources at hand required to manage and optimize your study:

[/fusion_text][fusion_checklist hide_on_mobile=”small-visibility,medium-visibility,large-visibility” size=”17px” divider=”yes” divider_color=”rgba(224,222,222,0)”][fusion_li_item]

COMPETENCE: InSIGHT’s development is based on operational excellence tailored to SCOPE’s processes.

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CUSTOMER-FOCUS: Adjusted to the specific needs of clients and users, our custom CTMS provides the flexibility needed to integrate 3rd party systems driving a “Best-of-Breed” solution.

[/fusion_li_item][fusion_li_item]

OVERSIGHT: Leave out the guess work and maintain a real-time overview with our sophisticated dashboards and trackers.

[/fusion_li_item][fusion_li_item]

EFFICIENCY: InSIGHT’s powerful document management features support collaboration from initial draft stages to approval, e-signature and final release of the field document.

[/fusion_li_item][fusion_li_item]

TRUST: Confidence and data integrity with controlled access to our integrated KaleidoSCOPE platform.

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Our electronic signature

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InSIGHT enables data import

[/fusion_text][/fusion_builder_column][/fusion_builder_row][/fusion_builder_container][fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” status=”published” border_style=”solid” padding_top=”20px” padding_bottom=”40px” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_color=”rgba(39,71,94,0)” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ background_blend_mode=”none” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ type=”legacy”][fusion_builder_row][fusion_builder_column type=”1_6″ type=”1_6″ spacing=”0%” center_content=”no” target=”_self” hide_on_mobile=”medium-visibility,large-visibility” hover_type=”none” border_style=”solid” border_position=”all” box_shadow=”no” box_shadow_blur=”0″ box_shadow_spread=”0″ background_type=”single” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_direction=”left” animation_speed=”0.3″ filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ first=”true” last=”false” margin_bottom=”0px” element_content=”” border_sizes_top=”0px” border_sizes_bottom=”0px” border_sizes_left=”0px” border_sizes_right=”0px” spacing_right=”0%” min_height=”” link=””][/fusion_builder_column][fusion_builder_column type=”2_3″ type=”2_3″ spacing=”0%” center_content=”no” target=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” hover_type=”none” border_style=”solid” border_position=”all” box_shadow=”no” box_shadow_blur=”0″ box_shadow_spread=”0″ background_type=”single” gradient_start_position=”0″ gradient_end_position=”100″ gradient_type=”linear” radial_direction=”center center” linear_angle=”180″ background_position=”left top” background_repeat=”no-repeat” background_blend_mode=”none” animation_direction=”left” animation_speed=”0.3″ filter_type=”regular” filter_hue=”0″ filter_saturation=”100″ filter_brightness=”100″ filter_contrast=”100″ filter_invert=”0″ filter_sepia=”0″ filter_opacity=”100″ filter_blur=”0″ filter_hue_hover=”0″ filter_saturation_hover=”100″ filter_brightness_hover=”100″ filter_contrast_hover=”100″ filter_invert_hover=”0″ filter_sepia_hover=”0″ filter_opacity_hover=”100″ filter_blur_hover=”0″ first=”false” last=”false” margin_bottom=”0px” border_sizes_top=”0px” border_sizes_bottom=”0px” border_sizes_left=”0px” border_sizes_right=”0px” spacing_left=”0%” min_height=”” link=””][fusion_content_boxes layout=”icon-on-top” columns=”1″ heading_size=”5″ iconspin=”no” icon_align=”left” animation_direction=”left” animation_speed=”0.3″ hide_on_mobile=”small-visibility,medium-visibility,large-visibility” title_size=”30″ outercirclebordersize=”0″ hover_accent_color=”#27475e” image_max_width=”65px”][fusion_content_box title=”PROJECT PLANNING” icon=”fa-tasks fas” circlecolor=”#33b5b6″ circlebordercolor=”rgba(51,51,51,0)” image=”https://scope-international.online/wp-content/uploads/icons_insight_project_planning.png” image_id=”3299|full” linktext=”Read More” animation_direction=”left” animation_speed=”0.3″ outercirclebordercolor=”rgba(231,231,231,0)”]

Set your project-specific expectations for essential documents, subject recruitment, monitoring visit (report) timelines and more

[/fusion_content_box][fusion_content_box title=”PROJECT TRACKING & VISUALIZATION” icon=”fa-chart-bar far” circlecolor=”#33b5b6″ circlebordercolor=”rgba(51,51,51,0)” image=”https://scope-international.online/wp-content/uploads/icons_insight_project_tracking.png” image_id=”3300|full” linktext=”Read More” animation_direction=”left” animation_speed=”0.3″ outercirclebordercolor=”rgba(231,231,231,0)”]

  • From action items to insurances, protocol deviations, regulatory submissions, subject recruitment, site status and many other areas – InSIGHT keeps track of data points from A-Z
  • Essential Documents Tracking and Monitoring Visit Report Documents Tracking are based on project specific document plans. Automated tracking occurs based on InSIGHT document workflows
  • The Performance Dashboards allow for overview at the desired information level: study, country, site
  • Built-in task management provides a transparent and efficient way of accomplishing all tasks
  • Alerts can be flexibly set and used to stay informed on how the documentation progresses
  • Overviews provide information about the involved study teams, countries and sites

[/fusion_content_box][fusion_content_box title=”DATA IMPORT
” icon=”fa-file-download fas” circlecolor=”#33b5b6″ circlebordercolor=”rgba(51,51,51,0)” image=”https://scope-international.online/wp-content/uploads/icons_insight_data_import.png” image_id=”3295|full” linktext=”Read More” animation_direction=”left” animation_speed=”0.3″ outercirclebordercolor=”rgba(231,231,231,0)”]

___Subject Data Import can be enabled regardless of which (e)CRF is being used

  • Makes manual subject entry in InSIGHT obsolete
  • Feeds into all required documents, trackers and dashboard
  • Eliminates discrepancies between different data sources

[/fusion_content_box][fusion_content_box title=”DOCUMENT MANAGEMENT” icon=”fa-file-alt far” circlecolor=”#33b5b6″ circlebordercolor=”rgba(51,51,51,0)” image=”https://scope-international.online/wp-content/uploads/icons_insight_document_management.png” image_id=”3296|full” linktext=”Read More” animation_direction=”left” animation_speed=”0.3″ outercirclebordercolor=”rgba(231,231,231,0)”]

InSIGHT´s powerful Document Management system supports your complete document lifecycle: from document template to draft document to approval and electronic signature to filing of the final document

  • The Document Template Manager allows for study-specific adaptation of document templates
  • InSIGHT populates documents automatically with system data
  • Flexible Document Workflows can be assigned to individual system users or user groups
  • Co-Authoring speeds up document finalization
  • The PDF converter supports conversion to and combination of documents as pdf
  • The E-signature feature allows for electronically signing of a document and verification of existing signatures
  • The Document Filing Tool displays in your libraries which documents are already filed in your (e)TMF

___Further time-savers

  • Batch Document Processing saves time
  • Integration with MS Office Package allows for work with known applications

[/fusion_content_box][fusion_content_box title=”ELECTRONIC SIGNATURE” icon=”fa-pen-nib fas” circlecolor=”#33b5b6″ circlebordercolor=”rgba(51,51,51,0)” image=”https://scope-international.online/wp-content/uploads/icons_insight_electronic_signature.png” image_id=”3297|full” linktext=”Read More” animation_direction=”left” animation_speed=”0.3″ outercirclebordercolor=”rgba(231,231,231,0)”]

  • Timely document signature loop completion and document authorization
  • A verification tool can be optionally employed to ensure that the document content did not change since signature loop was started

[/fusion_content_box][fusion_content_box title=”CONFIGURATION & CUSTOMIZATION” icon=”fa-magic fas” circlecolor=”#33b5b6″ circlebordercolor=”rgba(51,51,51,0)” image=”https://scope-international.online/wp-content/uploads/icons_insight_configuration.png” image_id=”3293|full” linktext=”Read More” animation_direction=”left” animation_speed=”0.3″ outercirclebordercolor=”rgba(231,231,231,0)”]

  • Role based access permissions for stakeholders of the specific project provide access on an ‘as needed basis’ and protection of confidential information
  • Study Project Management grants user access to the study and / or individual Investigational Trial Sites based on operational needs
  • Real-time access allows data analysis in accordance with the user’s areas of responsibility

[/fusion_content_box][fusion_content_box title=”COLLABORATION TOOLS” icon=”fa-network-wired fas” circlecolor=”#33b5b6″ circlebordercolor=”rgba(51,51,51,0)” image=”https://scope-international.online/wp-content/uploads/icons_insight_collaboration.png” image_id=”3292|full” linktext=”Read More” animation_direction=”left” animation_speed=”0.3″ outercirclebordercolor=”rgba(231,231,231,0)”]

  • InSIGHT´s collaboration tools facilitate and speed up shared efforts of the team
  • Shared Document Repository allows for sharing of documents within SCOPE and with Sponsors
  • Workflows & Task Notifications notify team members to relevant tasks
  • Alerts / Reminders support planning of the daily working life
  • Announcements keep the project team up to date with the latest project developments
  • Custom MS Outlook-Add-in facilitates document sharing with non-InSIGHT users

[/fusion_content_box][fusion_content_box title=”GLOBAL CONTACT DATABASE” icon=”fa-globe-americas fas” circlecolor=”#33b5b6″ circlebordercolor=”rgba(51,51,51,0)” image=”https://scope-international.online/wp-content/uploads/icons_insight_global_contact_database.png” image_id=”3298|full” linktext=”Read More” animation_direction=”left” animation_speed=”0.3″ outercirclebordercolor=”rgba(231,231,231,0)”]

  • SCOPE’s continuously growing internal contact database is far reaching and only accessible to SCOPE staff
  • The database facilitates identification of suitable investigational sites for the trial in a timely manner
  • Dedicated processes ensure that affected projects are notified of contact data updates that require follow-up action

[/fusion_content_box][fusion_content_box title=”CUSTOMIZATION & TECHNICAL SUPPORT” icon=”fa-headset fas” circlecolor=”#33b5b6″ circlebordercolor=”rgba(51,51,51,0)” image=”https://scope-international.online/wp-content/uploads/icons_insight_cutsominzation_technical_support.png” image_id=”3294|full” linktext=”Read More” animation_direction=”left” animation_speed=”0.3″ outercirclebordercolor=”rgba(231,231,231,0)”]

  • Having the development team in-house allows us to swiftly and flexibly react to your additional project specific needs
  • In-house user support is available for timely and straightforward issue resolution

[/fusion_content_box][fusion_content_box title=”QUALITY & REGULATORY” icon=”fa-star far” circlecolor=”#33b5b6″ circlebordercolor=”rgba(51,51,51,0)” image=”https://scope-international.online/wp-content/uploads/icons_insight_qualiry_regulatory.png” image_id=”3301|full” linktext=”Read More” animation_direction=”left” animation_speed=”0.3″ outercirclebordercolor=”rgba(231,231,231,0)”]

  • InSIGHT is developed and validated per state-of-the-art approaches and globally accepted industry development standards, e.g. GAMP5
  • InSIGHT is validated throughout its system life cycle to ensure that regulatory requirements such as ICH E6 and 21 CFR part 11 are met

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For detailed information about the individual InSIGHT features, download the InSIGHT Fact Sheet

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