Why You Need a Clinical Trial Management System (CTMS)

This video provides an in-depth exploration of the top ten reasons why organizations in the life sciences sector need to invest in a Clinical Trial Management System (CTMS). Param Singh, Vice President of Clinical Trial Management Solutions at BioPharm Systems, guides viewers through a structured presentation aimed at helping them build a solid business case for CTMS adoption. The webinar draws upon decades of implementation experience with CTMS solutions like Siebel Clinical and BioPharm Systems' accelerator, Ascend, across a diverse client base including pharmaceutical companies, Contract Research Organizations (CROs), medical device manufacturers, and academic institutions.

The presentation systematically breaks down each of the ten reasons, starting from simpler maintenance and culminating in scalable growth, explaining the operational and strategic advantages of a centralized CTMS. Key themes include enhancing data integrity, ensuring regulatory compliance, optimizing financial tracking, improving recruitment visibility, and facilitating seamless integration with other critical clinical systems. Singh emphasizes how a robust CTMS moves organizations away from fragmented data managed in spreadsheets and disparate databases towards a unified, controlled, and validated system that supports efficient clinical operations.

The discussion also delves into practical functionalities, such as the ability to create standardized document tracking packages, manage subject visit templates for payment and scheduling, and leverage comprehensive reporting tools for informed decision-making. A significant portion of the webinar is dedicated to a live demonstration of core CTMS features, specifically document tracking and study setup within the Ascend platform (a pre-configured version of Siebel Clinical). This hands-on segment illustrates how the system can enforce SOPs, manage document lifecycles, and streamline the setup of complex clinical protocols, including multi-regional studies and detailed subject visit schedules with flexible payment configurations. The speaker also addresses common questions regarding remote data entry, integration with safety systems and Electronic Trial Master Files (ETMFs), and multi-language capabilities, reinforcing the comprehensive nature of modern CTMS solutions.

Key Takeaways:

• Centralized Data Management for Simpler Maintenance: A commercial CTMS consolidates trial data from various sources (spreadsheets, homegrown databases) into a single system, minimizing duplicate data entry, reducing errors, and clarifying data storage locations. This also offloads maintenance to the vendor, allowing organizations to focus on core business.
• Robust Investigator Database: A CTMS provides a centralized, master repository for investigator information, ensuring data integrity by storing each investigator only once and associating them with multiple studies or sites. This facilitates efficient site selection and ensures data changes propagate across all related records.
• Transparent Financial Tracking: The system enables comprehensive monitoring of planned costs versus actual spend, budget adherence, and outstanding balances for investigators, sites, sponsors, and vendors. It enforces business rules and compliance through controlled payment workflows, aiding in cost savings and better planning for future trials.
• Streamlined Document Tracking: CTMS allows for the creation of standardized document lists applicable across different trial types, studies, and sites. It tracks the full lifecycle of documents, including attributes and dates, making it easier to identify outstanding, expired, or soon-to-expire documents and ensuring compliance with SOPs.
• Increased Recruitment Visibility: Real-time tracking of subject enrollment at the subject, visit, study, and regional levels helps identify high- versus low-performing investigators, analyze screen failures and early terminations, and accurately plan monitoring and data management resources.
• Critical System Integration: Integration with other clinical systems (e.g., safety systems, EDC, remote data capture, data warehouses, accounts payable, document management systems) is crucial. This reduces manual data entry, eliminates duplication errors, and provides a unified view for answering complex business questions without logging into multiple systems.
• Enhanced Regulatory Compliance: CTMS facilitates adherence to regulatory requirements (e.g., FDA, EMA, GxP, 21 CFR Part 11) through user access control, enforcement of SOPs via templates, and behind-the-scenes audit trails. A validated, controlled system simplifies audits compared to managing data in disparate files.
• Robust Reporting Capabilities: The system provides powerful ad-hoc and canned reporting tools, allowing users to quickly answer questions using historical and current data. It supports high-level executive summaries as well as detailed reports for site and study teams, offering real-time insights for trend analysis.
• Informed Decision Making: By providing real-time, comprehensive data, CTMS enables organizations to identify trends and inconsistencies across investigators, trials, and business units. This analysis helps pinpoint strengths, weaknesses, and areas of risk, allowing for proactive adjustments to ongoing studies and better planning for future ones.
• Scalable Growth with Minimal Overhead: A robust CTMS is designed to allow organizations to increase the number and size of managed trials with fewer resources. It consolidates and streamlines critical functions like subject tracking, investigator payments, document management, and site monitoring, enabling exponential growth without a proportional increase in operational costs.
• CTMS is Not a Document Management System (DMS): While CTMS offers document tracking and attachment capabilities, it is not a full-fledged DMS. For robust version control, document locking, and advanced document management features, integration with a dedicated DMS (e.g., SharePoint, Documentum, Livelink) via hyperlinks is the recommended approach.
• Remote Data Entry for Monitors: Enterprise CTMS solutions like Siebel Clinical offer remote capabilities, allowing monitors to install a standalone version on their laptops. This enables data entry even without internet access, with changes syncing to the central server once connectivity is re-established.
• Safety Reporting Integration: CTMS can track adverse events and serious adverse events from a monitoring perspective, but it is not a replacement for a dedicated safety system (e.g., Oracle Argus Safety). Integration points are crucial for reconciliation between the CTMS and the safety system.
• Electronic Monitoring Report Workflow: CTMS can generate electronic trip reports by pulling data from site and subject levels (enrollment statistics, adverse events, follow-up issues). These reports can support electronic approval with e-signatures and be integrated with a DMS for archiving, streamlining the entire workflow.
• Flexible Study Setup and Standardization: CTMS platforms like Siebel Clinical allow for extensive configuration to align with an organization's specific business processes and terminology. This includes defining subject visit schedules, payment milestones, and managing protocol amendments, while also providing flexibility for site-specific overrides and exceptions.

Tools/Resources Mentioned:

• Siebel Clinical: A prominent Clinical Trial Management System.
• Ascend: BioPharm Systems' pre-packaged, pre-configured accelerator built on Siebel Clinical, designed to provide industry-standard configurations.
• Oracle Argus Safety: Mentioned as a robust clinical safety system.
• SharePoint, Documentum, Livelink: Examples of document management systems that CTMS can integrate with.

Key Concepts:

• CTMS (Clinical Trial Management System): A software system designed to manage and track various aspects of clinical trials, from planning and setup to execution, monitoring, and closeout.
• EDC (Electronic Data Capture): Systems used for collecting clinical trial data in electronic format.
• SOPs (Standard Operating Procedures): Detailed, written instructions to achieve uniformity of the performance of a specific function.
• IRB (Institutional Review Board): A committee that reviews and approves research protocols involving human subjects.
• CRFs (Case Report Forms): Documents used to record data collected during a clinical trial.
• ETMF (Electronic Trial Master File): An electronic repository for all essential documents related to a clinical trial.