临床研究管理平台

AuroraPrime Comprehend

Clinical Study Data Insight and Tracking system

Prime Comprehend is a system that provides insight and tracking of trial data on the AuroraPrime clinical study platform. Prime Comprehend provides users with multi-dimensional data reports, visualizations, subscriptions and data insights based on standard data generated by each product module. Prime Comprehend adheres to the goal of "operationalizing all data and digitizing all operations", enabling users to run through the data generated by each product on the AuroraPrime platform, or connect to third-party data that conforms to ODM specifications, while meeting the requirements of multi-role, region-specific management and authorization in clinical trials to generate fully customizable, visualized, and holistic trial reports, study tracking dashboard, medical review dashboard, etc., and support early detection settings, insight rule settings, and custom data subscriptions.

Modules
Features
Benefits

Comprehensive dashboard]

The cross-study integrated dashboard (MyAurora) in Prime Comprehend is a multi-dimensional clinical study operations data insight hub. From the perspective of study operation, professional in-depth reports/dashboards including cross-study trial progress, site status, enrollment, subject analysis, visit analysis, query analysis, etc., provide clinical researchers with "out-of-the-box" ” operation process assistance, while granting users to different visual content based on their different roles.
Study Visualization

Prime Comprehend provides centralized visualization of operational management data and medical metrics data for individual studies. From the perspective of operation management, professional in-depth reports/dashboards including site status of a single study, enrollment status, subject analysis, visit analysis, query analysis, etc., provide study operators with assistance in the operation process; from the perspective of medical review , a medical dashboard including subject data profile, real-time efficacy indicators, indicator trend judgment, real-time survival curve, compliance, safety data, etc., to provide timely experimental judgment basis for medical personnel.
Custom dashboard & Reports

Prime Comprehend provides custom dashboards and reports that are flexible and easy to set up. Due to the different visual charts of different studies in different stages, various reports need to be continuously exported for offline processing and merging when reporting data. In Prime Comprehend, study personnel can easily define multi-dimensional dashboards and reports that meet your business scenarios.
Data Subscription

Prime Comprehend provides data subscription capabilities for various roles in clinical researchers (investigators), data management teams, project management teams, and medical teams can all subscribe to visualization dashboards that meet their role needs. For example, CRA can subscribe to subject visit schedule. After users subscribe, the system will automatically push the most important information to the mobile devices (such as mobile phones) of study personnel in the form of emails, text messages, etc., so that users can know the latest clinical trial progress and deal with relevant problems as soon as possible.
Cross-study Data Drilling

Prime Comprehend supports comprehensive comparison across studies, convenient in-depth exploration of existing issues, and comparative analysis of studies by site. You can drill down up to two levels to quickly locate critical problems.
Real-time analysis and presentation of medical indicators

For medical and safety indicators, rich statistical algorithms and corresponding visual charts are provided. Prime Comprehend provides key statistical algorithms such as parameter test (t test, F test, rank sum test, chi-square test...), regression analysis (Logistic, Poisson, COX...), contingency table analysis from the statistical level; Through visualization, common charts such as Bland-Altman chart, box chart, bubble chart, maximum matrix chart, forest chart, etc., are provided so that medical indicators can be presented to users clearly in real time.
Insight and Detection

Prime Comprehend's supporting insight engine and early warning detection engine operationalize clinical data. Project managers can freely define early detection rules, and data can trigger insights and make next-step predictions, suggestions, and task notifications, so that data can generate business value.
Subscribe on Demand

For each role, the system defines standard data push rules and forms. Users can complete data subscriptions that do not require content here, and can freely choose the form of email or SMS, so that key insights and suggestions can be directly pushed to users’ mobile devices.
Improve operation management efficiency

Prime Comprehend helps operations managers improve management efficiency from three levels. Data visualization can help operation managers to quickly find and locate problems; custom dashboard/reports can help operation managers reduce complicated data analysis work, improve efficiency and reduce the probability of errors; data subscription capability allows data to be pushed in a timely manner on demand To the mobile device of the operation manager, regardless of time and location, keep track of study progress and risk management at all times.
Detect problems earlier from a medical perspective

Prime Comprehend helps medical teams get medical analysis results faster and more timely. The DM or statistician can easily set the statistical parameters and algorithms in the protocol into Prime Comprehend, and the system will conduct real-time medical analysis and presentation according to the provided algorithm, so that the medical team can see the efficacy, safety, etc. For earlier detection of problems in clinical studies.
Build a private data warehouse

Prime Comprehend precipitates data for organizations and builds private data warehouses. The system supports the import of third-party data that conforms to ODM specifications, helping customers achieve unified management of information assets and saving labor costs.
Continuous accumulation of knowledge

Prime Comprehend supports the accumulation of corporate knowledge and experience in the system. The system includes management reports and dashboards for different stages of the study; medical analysis charts supporting different stages and indications can be continuously accumulated in the system to form the intangible assets of the enterprise. Users can easily provide relevant information to designated collaborators, and will not affect the precipitation of knowledge, the circulation and continuation of information due to changes in study personnel.

Modules

Comprehensive dashboard]

The cross-study integrated dashboard (MyAurora) in Prime Comprehend is a multi-dimensional clinical study operations data insight hub. From the perspective of study operation, professional in-depth reports/dashboards including cross-study trial progress, site status, enrollment, subject analysis, visit analysis, query analysis, etc., provide clinical researchers with "out-of-the-box" ” operation process assistance, while granting users to different visual content based on their different roles.
Study Visualization

Prime Comprehend provides centralized visualization of operational management data and medical metrics data for individual studies. From the perspective of operation management, professional in-depth reports/dashboards including site status of a single study, enrollment status, subject analysis, visit analysis, query analysis, etc., provide study operators with assistance in the operation process; from the perspective of medical review , a medical dashboard including subject data profile, real-time efficacy indicators, indicator trend judgment, real-time survival curve, compliance, safety data, etc., to provide timely experimental judgment basis for medical personnel.
Custom dashboard & Reports

Prime Comprehend provides custom dashboards and reports that are flexible and easy to set up. Due to the different visual charts of different studies in different stages, various reports need to be continuously exported for offline processing and merging when reporting data. In Prime Comprehend, study personnel can easily define multi-dimensional dashboards and reports that meet your business scenarios.
Data Subscription

Prime Comprehend provides data subscription capabilities for various roles in clinical researchers (investigators), data management teams, project management teams, and medical teams can all subscribe to visualization dashboards that meet their role needs. For example, CRA can subscribe to subject visit schedule. After users subscribe, the system will automatically push the most important information to the mobile devices (such as mobile phones) of study personnel in the form of emails, text messages, etc., so that users can know the latest clinical trial progress and deal with relevant problems as soon as possible.

Features

Cross-study Data Drilling

Prime Comprehend supports comprehensive comparison across studies, convenient in-depth exploration of existing issues, and comparative analysis of studies by site. You can drill down up to two levels to quickly locate critical problems.
Real-time analysis and presentation of medical indicators

For medical and safety indicators, rich statistical algorithms and corresponding visual charts are provided. Prime Comprehend provides key statistical algorithms such as parameter test (t test, F test, rank sum test, chi-square test...), regression analysis (Logistic, Poisson, COX...), contingency table analysis from the statistical level; Through visualization, common charts such as Bland-Altman chart, box chart, bubble chart, maximum matrix chart, forest chart, etc., are provided so that medical indicators can be presented to users clearly in real time.
Insight and Detection

Prime Comprehend's supporting insight engine and early warning detection engine operationalize clinical data. Project managers can freely define early detection rules, and data can trigger insights and make next-step predictions, suggestions, and task notifications, so that data can generate business value.
Subscribe on Demand

For each role, the system defines standard data push rules and forms. Users can complete data subscriptions that do not require content here, and can freely choose the form of email or SMS, so that key insights and suggestions can be directly pushed to users’ mobile devices.

Benefits

Improve operation management efficiency

Prime Comprehend helps operations managers improve management efficiency from three levels. Data visualization can help operation managers to quickly find and locate problems; custom dashboard/reports can help operation managers reduce complicated data analysis work, improve efficiency and reduce the probability of errors; data subscription capability allows data to be pushed in a timely manner on demand To the mobile device of the operation manager, regardless of time and location, keep track of study progress and risk management at all times.
Detect problems earlier from a medical perspective

Prime Comprehend helps medical teams get medical analysis results faster and more timely. The DM or statistician can easily set the statistical parameters and algorithms in the protocol into Prime Comprehend, and the system will conduct real-time medical analysis and presentation according to the provided algorithm, so that the medical team can see the efficacy, safety, etc. For earlier detection of problems in clinical studies.
Build a private data warehouse

Prime Comprehend precipitates data for organizations and builds private data warehouses. The system supports the import of third-party data that conforms to ODM specifications, helping customers achieve unified management of information assets and saving labor costs.
Continuous accumulation of knowledge

Prime Comprehend supports the accumulation of corporate knowledge and experience in the system. The system includes management reports and dashboards for different stages of the study; medical analysis charts supporting different stages and indications can be continuously accumulated in the system to form the intangible assets of the enterprise. Users can easily provide relevant information to designated collaborators, and will not affect the precipitation of knowledge, the circulation and continuation of information due to changes in study personnel.