Clinical research is highly competitive and regulated. Staying on top of study oversight and management is crucial for research sites aiming to run efficient, compliant, and impactful trials. But with many moving parts – including study start-up, patient recruitment, compliance tracking, and more – managing numerous trials across multiple locations can become overwhelming.
Many research sites still battle with manual or disparate processes. This can make it burdensome to ensure that every aspect of a study is in sync, which can ultimately lead to delays, increased costs, and data inaccuracies. For this reason, recognizing these challenges, RealTime eClinical Solutions developed a comprehensive platform of our leading clinical trial technology solutions – a total Site Operations Management System (SOMS).
SOMS is designed to help clinical research sites streamline study operations, foster real-time communication, and improve oversight from start to finish.
What is SOMS?
RealTime’s Site Operations Management System (SOMS) addresses the challenges facing modern day research organizations. SOMS is an integrated, centralized platform for tracking, managing, and optimizing all aspects of study operations. By bringing real-time data visibility, workflow automation, and collaborative tools, SOMS eliminates silos for total trial transparency.
In fact, one of the unique benefits of SOMS is its flexibility. While the platform is fully integrated, it’s not an “all-or-nothing” system. Research organizations can start with CTMS and activate other solutions and features as their processes and operations scale.
With SOMS, sites can stay on top of critical trial metrics, improve team coordination, and reduce delays. Altogether, this paves the way for more effective, impactful research.
What’s Included in RealTime-SOMS?
The SOMS product suite all work together across the entire trial process to improve workflows, automate data analysis, and improve clinical trial outcomes. SOMS combines the power of several industry-leading tools to empower organizations at every stage of the research process, with data flowing seamlessly throughout.
The products featured in this powerful bundle include:
Devana: Pipeline Management + Performance Intelligence
Devana transforms how research organizations track and optimize their trial pipelines. From feasibility to award, Devana delivers real-time insights into site performance metrics, sponsor relationships, and operational efficiency. It empowers leaders with data-driven visibility, enabling faster decisions, stronger forecasting, and better alignment across departments.
Clinical Trial Management System (CTMS) : Centralized Study Oversight
A Clinical Trial Management System (CTMS) is a centralized platform that assists site staff in optimizing the planning, execution, and management of clinical trials. RealTime-CTMS is the foundational solution for our eClinical platform suite. Integrating multiple products and capabilities, our enterprise-grade CTMS enables clinical research sites to streamline all aspects of trial execution. This includes recruitment, CRC activities, finances, site management, and more.
eSource : Real-Time Data Capture
In the past, source data in clinical trials – such as patient information, lab results, and treatment details – was recorded on paper. RealTime-eSource is a cloud-based electronic source (eSource) data capture solution that replaces paper with a secure electronic solution that enables immediate data capture at the point of care. eSource is purpose-built to improve data accuracy, lower FDA audit risk, and reduce protocol deviations. RealTime-eSource boosts site efficiency and even enables coordinators to handle a greater volume of studies, without compromising data quality or compliance.
eReg/eISF: Regulatory Compliance, Simplified
From the pioneers of RealTime-eDocs and Complion eISF, our user-friendly electronic document management and regulatory systems are built for clinical research sites and academic medical centers. With RealTime-eReg/eISF, research organizations simplify document management, storage, retrieval, and collaboration across site teams or departments.
Engage!: eConsent + Participant Portal
Boost participation and keep your research on track with RealTime-Engage! Including the MyStudyManagerTM participant portal and eConsent, Engage! offers tools to easily connect with participants for a smoother study experience.
Pay: Instant, Integrated Reimbursement
Simplify the reimbursement process with secure, integrated digital payments for faster and more convenient payouts with RealTime-Pay.
Text : Improve Global Participant Communications
Integrated directly into CTMS, RealTime-Text enables two-way SMS communication with participants worldwide, including the U.S., Canada, Australia, Europe, and New Zealand.
Benefits of an Integrated Trial Management Platform
Without an efficient trial management system, sites risk missing deadlines, falling short on patient recruitment goals, or failing to meet compliance standards. Proper oversight is essential not only for meeting regulatory requirements but also for ensuring the integrity and quality of trial outcomes. Unfortunately, managing these aspects of a study is often easier said than done, particularly for multi-site research organizations or Academic Medical Centers (AMCs), where complexity increases with each new trial. Relying on traditional paper-based systems invites additional risk and the headaches of physical storage and time spent chasing down documents. Using disparate technology platforms may seem helpful at first, especially when choosing best-of-breed solutions. However, things start to fall apart when facing the reality of managing multiple logins, dealing with systems that don’t connect, and lacking true end-to-end visibility and data.
By providing a comprehensive, centralized platform that allows teams to manage every part of the trial process in real-time and in the same place, RealTime-SOMS ensures research sites can maintain high standards of oversight, from patient recruitment to data collection and compliance. Through a single system, sites can track performance metrics, monitor recruitment progress, and oversee regulatory compliance – creating an ecosystem that promotes operational efficiency and improves study quality.
RealTime-SOMS empowers sites to streamline all aspects of their clinical research operations with inter-connected products working in tandem to accelerate workflows across the board. With SOMS, you can:
Recruit and manage studies efficiently with CTMS, streamlining recruitment pipelines, visit scheduling, investigator oversight, and financial tracking, all from a single dashboard.
Engage participants seamlessly through Engage! to improve enrollment and enhance the study experience.
Strengthen compliance and audit readiness using built-in controls and real-time oversight with eSource and eReg/eISF.
Optimize financial management with transparent reporting, automated billing, and real-time tracking with Pay.
Communicate instantly and securely with participants using Text to reduce no-shows and improve retention.
Unify central operations across departments and teams, as well as provide leadership with full visibility into start-up timelines, metrics, and site performance with Devana.
Stay connected anytime, anywhere. Access SOMS on the go with the RealTime Mobile App.
How a Site Network Grew Revenue 500% with RealTime-SOMS
An example of these benefits in action can be seen in a RealTime case study featuring Revival Research. Like many sites, Revival Research was skeptical about onboarding a new technology solution. After much deliberation, RealTime was selected because of its comprehensive features, flexibility, and commitment to adapting to changing needs over time.
By leveraging RealTime-SOMS, Revival was able to scale operations and drive a 500% revenue increase by expanding their research sites from 5 to 18, reducing compliance violations, and improving team oversight. Revival’s adoption of SOMS led to optimized workflows, cost savings, and strengthened compliance – all while ensuring efficient remote data access and monitoring.
In addition to their considerable revenue increase, RealTime’s integrated solutions also reduced Revival’s staffing needs by 50%, highlighting the critical role of technology in supporting sustained growth and operational efficiency.
Transforming Research Operations with RealTime-SOMS
In summary, SOMS enables research sites to handle larger study portfolios with greater ease and accuracy. Overall, the system makes it possible to scale operations without compromising quality or compliance. And by integrating Devana’s performance analytics with RealTime’s enterprise-grade CTMS, sites gain a single source of operational truth.
With access to centralized, real-time data, Principal Investigators, site directors, and coordinators are better equipped to make proactive, data-based decisions that reduce trial delays, improves recruitment strategies, and drive better overall outcomes.
In today’s modern clinical trial environment, SOMS provides the essential eClinical toolkit necessary for AMCs, health systems and site networks to thrive. By centralizing study oversight and management into a single, streamlined platform, RealTime-SOMS helps sites meet the demands of an increasingly complex industry with confidence and precision.
Read More: Maximizing Budgets in Clinical Trials: The Financial Advantages of an Integrated eClinical Solution
Read More: A Single Source of Truth: How Cedar Health Research Increased Patient Recruitment by 160%
Frequently Asked Questions - What is SOMS
Q: What exactly is SOMS?
A: SOMS stands for Site Operations Management System. It’s a centralized, integrated platform designed to help research sites, site networks, and academic medical centers streamline study operations by bringing real-time data, workflow automation, and communication tools into one unified system.
Q: Why do sites need SOMS?
A: Without an efficient trial-management system, sites risk missed deadlines, under-target recruitment, and compliance issues. The complexity increases with multi-site studies or AMCs; traditional paper-based or fragmented systems make it harder to maintain oversight and quality. SOMS helps by providing a single ecosystem for visibility, efficiency, and scale.
Q: What products/features are included in SOMS?
A: SOMS is a unified suite of eClinical solutions, which include:
CTMS – manages planning, recruitment pipeline, finances, site operations.
eSource – cloud-based source data capture at the point of care.
eReg / eISF – electronic regulatory and document management.
Engage! – participant portal and eConsent with recruitment, reminders, and connection tools.
Pay – digital payments for participants and study resources.
Text – global SMS communication integrated to improve participant engagement and reduce no-shows.
Devana – business operations, pipeline management, metrics and site performance analytics.
Mobile App – enables access to SOMS tools on the go, anytime, anywhere.
Q: Can teams adopt parts of SOMS, or do they have to implement the full suite at once?
A: You don’t have to implement the entire system at once. SOMS is designed to be flexible. Organizations can start with CTMS and activate additional modules as they scale+.
Q: How does SOMS help with study performance and quality?
A: By centralizing workflows and data, SOMS gives teams real-time oversight of metrics, recruitment progress, compliance status, finances, and participant engagement. This improves operational efficiency, enhances study quality, and enables sites to manage larger portfolios without sacrificing accuracy or compliance.
Q: Who is SOMS built for?
A: SOMS is built for clinical research sites, site networks, academic medical centers (AMCs), and health systems that run complex, multi-site trials and need unified tools to oversee their operations end-to-end.
Q: What is the key benefit of choosing an integrated system like SOMS versus multiple disparate solutions?
A: Disparate systems can create silos, require multiple logins, and lack true end-to-end visibility. With an integrated SOMS, data flows seamlessly across modules, workflows are unified, and teams gain one source of truth. With SOMS, site-based teams reduce risk, improve oversight, and accelerate timelines.
About RealTime eClinical Solutions
RealTime eClinical Solutions is a leading eClinical technology provider reshaping the landscape of clinical trials with its comprehensive eClinical platform. Purpose-built for clinical research sites, site networks, AMCs, sponsors, and CROs, the platform goes beyond traditional clinical trial management systems to empower research and business workflows for modern-day clinical trials – from trial award and study start-up through to trial execution. RealTime helps organizations manage the research and business of clinical trials, together, with software solutions including CTMS, eReg/eISF, eSource, participant payments (SitePay/GlobalPay), engagement solutions (Text, eConsent, and MyStudyManager™ Participant Portal), and Devana for pipeline management, business operations, and process and performance metrics.