Webinar: Actionable milestones to connect and control project performance throughout CTMS & eTMF

This webinar, presented by Flex Databases, provides an in-depth exploration of how "actionable milestones" can be effectively utilized within their integrated CTMS (Clinical Trial Management System) and eTMF (electronic Trial Master File) to connect and control project performance throughout clinical trials. The core purpose is to demonstrate how a synchronized milestone system can optimize project management, streamline document tracking, automate financial processes, and enhance reporting capabilities, ultimately leading to greater transparency and efficiency in clinical operations. The presenters, Montasser (Project Manager) and Kenya (from Flex Databases), highlight the system's ability to address common pain points such as miscommunication, delays in financial processes, and challenges in assessing project completeness.

The session begins by establishing the fundamental need for milestones in project management, emphasizing their role in meeting deadlines, allocating resources, increasing study visibility, and demonstrating success for financial targets. A key theme is the concept of "rolling milestones" and "connected vessels," illustrating how milestones, once defined, automatically synchronize and travel across various modules of the Flex Databases system. This includes the Project Catalog (initial source), eTMF (for document completeness), CTMS (for site-level data), and Project Management & Budgeting (for financial tracking). The webinar progresses by detailing the implementation of milestones in each of these areas, providing specific examples and demonstrating the system's functionalities through brief video demos.

Throughout the presentation, the speakers underscore the system's unique methodologies, such as the automatic "Roll-Ups" feature, where site-level milestone achievements (e.g., first patient in) automatically update country and global/study level milestones, taking the earliest date for the global achievement. This significantly reduces manual data entry and potential errors in multi-country studies. Furthermore, the integration of milestones with budgeting and invoicing rules allows for automated generation of invoices based on milestone completion, ensuring timely cash flow management. The final segment focuses on the comprehensive reporting tool, which leverages all interconnected milestone data to generate predefined and custom reports, charts, and graphs for assessing performance, identifying bottlenecks, and troubleshooting. This holistic approach aims to provide all stakeholders, from project managers to finance teams and sponsors, with real-time, actionable insights into trial progress and performance.

Key Takeaways:

• Centralized Milestone Management: Milestones are established at the project's inception within a "Project Catalog" and serve as the initial, single source of truth for project progress, supporting resource allocation and enhancing study visibility.
• Automated Milestone Synchronization: Once defined, milestones automatically "travel" and synchronize across various modules of the Flex Databases system, including eTMF, CTMS, and Project Management & Budgeting, ensuring consistent data across all departments.
• eTMF Completeness by Milestone: Milestones are integrated into the eTMF to automatically assess document completeness. The system indicates expected and missing documents for specific milestones, guiding teams on what needs to be uploaded or finalized to meet deadlines and ensure regulatory readiness.
• Dynamic CTMS Integration: Site-level data entered into the CTMS (e.g., a PI indicating the first patient recruited, or a CRA uploading an SQV report) automatically updates the corresponding milestones across the entire system, eliminating miscommunication and manual tracking.
• Hierarchical Milestone Roll-Ups: The system supports three levels of milestones: site, country, and global/study. Site-level milestone achievements automatically roll up to country and global levels, with the system identifying and applying the earliest date for the global achievement, which is crucial for international studies.
• Flexible Milestone Timelines: Milestones can be defined with three key dates: "Planned Date" (initial target), "Forecast Date" (team's expectation), and "Actual Date" (when achieved), allowing for comprehensive tracking against original plans and current predictions.
• Automated Milestone-Based Invoicing: The system enables the creation of invoicing rules tied to milestone achievements. When a milestone is reached, the finance team is immediately aware, and invoices can be automatically generated for sponsors, optimizing cash flow and reducing manual effort.
• Task Dependency Automation: Project tasks can be linked to specific milestones. If a milestone's date changes (e.g., the planned date is adjusted), the dates of all connected tasks automatically update, maintaining the integrity and accuracy of the project plan.
• Comprehensive Reporting Capabilities: All synchronized milestone data feeds into a powerful "Report Tool," allowing users to generate predefined reports (e.g., overdue, upcoming milestones) or create custom reports with charts and graphs to assess project performance, identify bottlenecks, and troubleshoot based on real data.
• Configurable Grace Periods for Documents: For documents associated with eTMF milestones, the system allows for configurable grace periods (e.g., days for upload, days for review) in the system settings, providing flexibility while still tracking compliance.
• Support for Diverse Invoicing Milestones: The system accommodates both project-driven and financially-driven milestones for invoicing, offering flexibility to align with various contractual payment terms beyond just project progress.
• Future Logic Checks for Milestones: While not currently implemented, the idea of introducing logic checks (e.g., ensuring a patient is screened before being "in") for default milestones was acknowledged as a valuable future development, indicating a focus on data integrity.

Tools/Resources Mentioned:

• Flex Databases: The overarching platform providing the CTMS, eTMF, Project Catalog, Project Management & Budgeting, Report Tool, and Investigators and Site Management modules.
• DIA (Drug Information Association): Mentioned as a source for recommended eTMF structures, which the Flex Databases system can accommodate.

Key Concepts:

• Actionable Milestones: Project measurements that, upon achievement, trigger specific actions, updates, or assessments within the system, driving project progress and automation.
• CTMS (Clinical Trial Management System): A software system designed to manage and track various operational aspects of clinical trials, including site and patient data.
• eTMF (electronic Trial Master File): A secure, electronic repository for all essential clinical trial documents, crucial for regulatory compliance and audit readiness.
• Roll-Ups: A data aggregation feature where information from lower-level entities (e.g., site-specific milestone dates) automatically updates higher-level entities (country or global study milestones).
• Connected Vessels: A metaphor used to describe the seamless, real-time data synchronization and flow between different modules of the Flex Databases system.
• Planned Date: The initial target date for a milestone, often agreed upon during study planning or in contracts.
• Forecast Date: The project team's current prediction for when a milestone will be achieved.
• Actual Date: The definitive date on which a milestone was successfully completed.
• Lap: The calculated difference in days between planned/forecast dates and the actual achievement date, used to measure performance against schedule.

Examples/Case Studies:

• eTMF Document Management: The "clinical infrastructure ready" milestone is used to demonstrate how the system tracks required documents (e.g., TMF plan, monitoring plan, quality plan, list of SOPs). It highlights how the system shows expected and missing documents, along with their deadlines, to ensure timely completion.
• Site-level Data to Global Milestone: A scenario where a site in Germany recruits its first patient on November 2nd. This date, entered by the Principal Investigator (PI) in the "Investigators and Site Management" module of CTMS, automatically updates the "first subject in" milestone in the Project Catalog and other relevant system parts.
• Automated Invoice Generation: An example of an invoicing rule tied to the "first site activated" milestone. Upon this milestone's achievement, the system automatically generates an invoice for the sponsor based on pre-defined budget assumptions and tasks.
• Performance Reporting: Custom reports are shown comparing "site activation to first subject in" periods across different sites and countries, displaying planned vs. actual dates and the "lap" (time difference). Another report tracks "protocol finalized to first site initiated" at a global level, showing planned, forecast, and actual dates to assess overall study progress.