RealTime Site Operations Management System (SOMS)

The video introduces the RealTime Site Operations Management System (SOMS), positioning it as the most comprehensive and powerful solution developed for clinical research sites and site networks. The core value proposition of SOMS is the integration of multiple, proven standalone solutions into a single, customizable, and user-friendly interface designed to manage all facets of site operations efficiently. This integrated approach aims to help research sites achieve "peak performance" by consolidating disparate functions typically managed across multiple systems.

The foundation of the SOMS is the RealTime Clinical Trial Management System (CTMS), which offers extensive features spanning both commercial and operational aspects of clinical trials. On the commercial side, the CTMS includes sophisticated recruitment modules that facilitate marketing campaign management, website and social platform integration, email client integration, lead tracking, and call center management features. Crucially, it also incorporates automated and direct-to-patient text messaging capabilities and robust campaign result reporting, allowing sites to optimize their patient acquisition strategies. Operationally, the CTMS manages essential functions such as subject visits, study financials (invoicing, collections, and payables), and scheduling, complete with Outlook integration.

The true power of the RealTime SOMS lies in its ability to seamlessly integrate optional, complete systems directly into the CTMS interface. These specialized modules address critical areas of clinical trial execution and compliance. Specifically, the system offers RealTime Pay for streamlined subject payments, RealTime Text for sending patients timely alerts regarding upcoming appointments, and RealTime eReg for comprehensive electronic regulatory management. Perhaps most critically for data integrity and compliance, the system includes RealTime eSource, which enables sites to collect data electronically. This feature is highlighted as essential for ensuring complete, accurate, and compliant data collection, while also providing real-time access to study data for sponsors and Contract Research Organizations (CROs). The overall message emphasizes that this unified system simplifies complex clinical operations, driving efficiency and regulatory adherence.

Key Takeaways: • Integrated Site Operations Management: The RealTime SOMS is presented as a unified platform that bundles previously standalone solutions (CTMS, eReg, eSource, Payments) into a single interface, eliminating data silos and improving operational efficiency for clinical research sites and site networks. • Comprehensive Recruitment and Marketing Tools: The CTMS component features advanced recruitment modules, including capabilities for managing marketing campaigns, integrating with social platforms and websites, tracking leads, and utilizing call center management features, which are vital for optimizing patient enrollment. • Automated Patient Communication: The system leverages automated and direct-to-patient text messaging (via RealTime Text) for appointment alerts and communication, significantly reducing no-show rates and improving patient engagement throughout the trial lifecycle. • Financial and Administrative Streamlining: Core administrative functions are managed within the CTMS, including the tracking of subject visits, comprehensive study financials (invoicing, collections, and payables), and scheduling with integrated Outlook functionality. • Electronic Regulatory Compliance (eReg): The RealTime eReg module provides complete electronic management of regulatory documentation, which is crucial for maintaining audit readiness and adhering to complex clinical trial regulations. • Compliant Electronic Source Data (eSource): The RealTime eSource system allows for electronic data collection directly at the site, ensuring that data is complete, accurate, and compliant, thereby addressing critical requirements for GxP and regulatory standards. • Real-Time Data Access for Sponsors/CROs: The system facilitates enhanced transparency by providing sponsors and CROs with real-time access to study data, enabling faster decision-making and oversight, which is a key requirement for modern decentralized clinical trials. • Opportunity for AI/Automation Integration: The consolidation of recruitment data, financial data, regulatory documents, and eSource data into one system creates a robust, centralized data foundation, making it an ideal candidate for AI and LLM solutions aimed at predictive analytics, automated reporting, and intelligent workflow optimization.

Tools/Resources Mentioned:

• RealTime Site Operations Management System (SOMS)
• RealTime CTMS (Clinical Trial Management System)
• RealTime Pay (Subject Payment System)
• RealTime Text (Patient Alert System)
• RealTime eReg (Electronic Regulatory Management System)
• RealTime eSource (Electronic Source Data Collection System)
• Outlook (Integration for scheduling)

Key Concepts:

• Site Operations Management System (SOMS): A holistic platform designed to manage all administrative, financial, regulatory, and patient-facing activities required to run a clinical research site efficiently.
• CTMS (Clinical Trial Management System): Software used by pharmaceutical companies and clinical research sites to manage and track the operational aspects of a clinical trial, including subject enrollment, milestones, budgets, and deadlines.
• eSource: The electronic capture of source data (the original data recorded in a clinical trial) directly into an electronic system, ensuring data quality and compliance while eliminating the need for paper records.
• eReg: The electronic management of essential regulatory documents required for clinical trials, replacing traditional paper binders and streamlining the audit process.