Intrinsic Clinical Systems - Using CRO Data to Automatically Feed Your CTMS

This video provides an in-depth demonstration of Intrinsic Clinical Systems, a Clinical Trial Management System (CTMS) developed by Pharmaca Consulting, focusing on its ability to efficiently integrate data, particularly from Contract Research Organizations (CROs), to automate CTMS updates and eliminate manual data entry. The presentation begins by outlining the common pain points associated with legacy CTMS solutions, which were often described as large, prohibitively expensive, packed with unused modules (like grants or drug supply), technologically antiquated, and requiring a heavy IT footprint due to varied platform architectures. The core mission of Intrinsic Clinical Systems was to address these issues by creating a light, modern, and easy-to-navigate system.

The foundational architecture of the Intrinsic CTMS is built upon the Microsoft Dynamics operational platform. This strategic choice is highlighted as a key differentiator, providing native integration with the Microsoft Office Suite (Outlook, SharePoint, and Excel). This integration allows users to leverage familiar interfaces, utilize SharePoint for secure, HIPAA-compliant storage of eTMF documents, and view system reports directly within Outlook in real-time. The system is designed to be intuitive, requiring minimal training for users familiar with clinical trials, positioning it as a middle ground between expensive legacy systems and smaller, cloud-based startups.

A significant portion of the demonstration focuses on data management, workflow, and integration capabilities. The system organizes clinical trials hierarchically (Project, Study, Study Country, Site) and employs role-based security (e.g., Global Admin, Study Manager, Read-Only Executive) to control user access and permissions, contrasting with user-based systems. To maintain high data standards, the system leverages Microsoft CRM’s duplicate detection settings, flagging similar entries for investigators or institutes based on criteria like email, phone number, and name characters, thereby preventing data duplication and misspelling across studies. Integration with external systems, particularly CROs, is achieved through three primary methods: building a direct API for sophisticated, real-time data transfer; utilizing a low-tech export/import feature via dynamic Excel templates for bulk updates; or setting up scheduled nightly data pulls from a designated SharePoint directory where CROs can upload files.

Finally, the presentation covers the system’s Business Intelligence (BI) and reporting features, which utilize Microsoft Power BI. The system offers 10 out-of-the-box visualizations, including portfolio-wide views, study enrollment status reports, and site startup graphs. Users are also empowered with ad hoc reporting functionality by creating unlimited customizable "personal views" within the tabular data displays, allowing them to select and filter specific columns (e.g., budget information) and export these views as dynamic Excel worksheets that refresh automatically when opened. The system also confirms its regulatory focus, noting that its Trip Report functionality (covering routine monitoring, site initiation, and close-out visits) is actively undergoing 21 CFR Part 11 validation.

Key Takeaways:

• Modern CTMS Architecture: Intrinsic Clinical Systems is built on the Microsoft Dynamics operational platform, offering a light, modern alternative to legacy CTMS solutions that are often criticized for being expensive, feature-heavy, and technologically antiquated.
• Native Microsoft Integration: The system provides seamless integration with the Microsoft Office Suite, enabling users to leverage familiar tools like Outlook (for real-time report viewing), Excel (for data import/export), and SharePoint (for HIPAA-compliant eTMF document storage).
• CRO Data Integration Methods: The CTMS supports three distinct methods for integrating clinical data from CROs and other external systems: direct API builds for sophisticated real-time data flow, bulk data upload via dynamic Excel templates, and scheduled nightly data pulls from designated SharePoint directories.
• High Data Standards via Duplicate Detection: The platform utilizes Microsoft CRM’s inherent duplicate detection settings to enforce data quality for critical entities like Investigators and Institutes, preventing study managers from entering duplicate or slightly misspelled records.
• Role-Based Security: Access control is managed through predefined roles (e.g., Global Admin, Study Manager, Read-Only Executive), allowing organizations to precisely control what information different user groups can read, write, or access, rather than relying on complex user-by-user permissions.
• Ad Hoc Reporting Functionality: Users can create unlimited custom "personal views" within the system’s tabular displays by easily adding or removing columns, effectively functioning as an ad hoc reporting tool to quickly visualize data points important to them (e.g., budget information).
• Dynamic Data Export: Data can be exported as a dynamic Excel worksheet, which maintains a link to the CTMS database and automatically refreshes when opened, ensuring users always have the most current information without manual re-exporting.
• Power BI for Business Intelligence: The system uses Microsoft Power BI for its out-of-the-box visualizations (10 available), providing comprehensive views of portfolio-level data, study enrollment status, and site startup metrics.
• Regulatory Compliance Focus: The system is actively working toward 21 CFR Part 11 validation for its Trip Report functionality, which includes forms for routine monitoring, site qualification, site initiation, and close-out visits, ensuring compliance for electronic records and signatures.
• Simplified Workflow: The system guides users through the clinical trial setup process using a clear hierarchy: Project, Study, Study Country, and Site, with mandatory fields kept minimal to allow for quick placeholder creation during the initial setup phase.

Tools/Resources Mentioned:

• Microsoft Dynamics (Operational Platform)
• Microsoft Office Suite (Outlook, SharePoint, Excel)
• Microsoft Power BI (Visualization Tool)
• Spotfire (Mentioned as a comparable visualization tool)
• Tableau (Mentioned as a comparable visualization tool)

Key Concepts:

• CTMS (Clinical Trial Management System): Enterprise software used to manage and track clinical trial operations, including site information, milestones, enrollment, and regulatory documents.
• eTMF (Electronic Trial Master File): A digital repository for essential clinical trial documents, often integrated with or stored via the CTMS platform (Intrinsic uses SharePoint for this).
• 21 CFR Part 11: FDA regulation governing electronic records and electronic signatures, a critical compliance requirement for pharmaceutical software systems, particularly for documents like Trip Reports.
• General Entities: System-wide data repositories (e.g., Investigators, Institutes, Projects) used for high-level viewing, navigation, and as a source of truth for specific studies.
• Specific Entities: Information pertaining only to a particular record (e.g., Milestones or Trip Reports associated with a single Study or Site).