Automation in Reporting

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Automation in Reporting

With the demand for new safety requirements, time and accuracy in generation of reports is pivotal for informed decision-making. Recognizing this imperative, automated reporting within clinical trial software takes center stage. This feature not only streamlines the reporting process but also ensures that crucial information is automatically generated in the background, as needed. By seamlessly generating reports in real-time, it accelerates workflows, providing stakeholders with up-to-the-minute insights without manual intervention. This underscores a commitment to advancing clinical trial management through technological innovation, emphasizing the significance of automated, on-demand reporting for efficient and effective decision support.

Benefits

Controlled Document Management

Implementing Controlled Document Management, securely lock and archive clinical data, including screening records and laboratory reports. This ensures the meticulous tracking of controlled documents, maintaining accountability and integrity throughout the data lifecycle. By centralizing document control, this approach fortifies regulatory compliance, safeguards sensitive information, and streamlines audit trails for a robust and accountable document management system.

Holistic Reporting

Utilize the benefits of automatically generated periodic reports within the software system. In addition to standard analysis reports, access comprehensive global study reports effortlessly. Enjoy the convenience of automated notifications and download these reports in the required format, showcasing the software system's robust capability for holistic reporting.

Role-Based Reporting

Adapting decision-making processes to individual responsibilities, we recognize that each user has unique data analysis needs. To address this, our software system offers role-based reporting, ensuring that each user accesses data pertinent to their specific decision-making requirements within the confines of their designated role. This capability enhances efficiency by delivering customized insights tailored to individual responsibilities.

Automation in Reporting for BA/BE Studies & Early Phase Clinical Trials

Automation in Reporting

Clinical Data (with Screening Records and Laboratory Reports) Locking & Archival
Controlled Documents Record Tracking
Data Cleaning and Validation
Trial Data Compilation for Dossier Preparation
Medical Coding from Standard Dictionaries
External File Upload & Extraction
Image File OCR Processing with TOC & Bookmarks

Standard Report

Access organized study data to verify and analyze throughout the study, suitable for regulatory submissions.
Advanced 360-degree Report

Retrieve Subject reports with expanded subject data, adding custom fields based on study design elements.
Annotated Case Report Forms

Generate blank case report forms with specific annotations, including details about form and question names.
Global Study Roles Report

View information on all study roles across the organization, covering both default settings and retired roles.
Study Roles Report (by study)

Access information on study roles specific to an assigned study.
Training Report

View completed Study training for specific protocols, providing evidence of user training completion.
Kit Dispensation Report

View dispensation details for subjects in a study, listing IMPs dispensed at each event, including replacements.
IMP Inventory Report

View the current status of all IMPs in inventory.
Randomization List (Unblinded) Report

Access current and historical data for every randomization number, including subjects assigned to each.
Study Design Report

View settings specified for your study design, including visits, forms, kit, randomization information, and subject settings.
Study Enrollment Report

Access details about enrollment for a study.
Subject Data Report

View all data collected on every form in the study, including study version details.
Subject Visits Report

Obtain blinded details about each subject's visits and treatments, providing a comprehensive view of scheduled, completed, and projected visits.
User Assignment Across Studies Report

User Assignment Across Studies Report
Discrepancy Report

View all recorded study discrepancies.
Data Extracts

Data managers, statisticians, and sponsor users can extract cumulative study data for analysis or regulatory reporting.
CRF Submit Archives and Reports

Generate and download study archives and reports using CRF Submit, useful for mid-study data analysis and end-of-study regulatory submissions..