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. For many research sites, manual or disparate processes make it challenging to ensure that every aspect of a study is in sync, which can 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) is designed to address the challenges facing modern day research organizations, providing an integrated, centralized platform for tracking, managing, and optimizing all aspects of study operations. By bringing real-time data, workflow automation, and streamlined communication into one bundled system, SOMS empowers research sites to oversee their studies with greater accuracy, efficiency, and transparency.
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 activate only the features they need initially and then add on other components as their processes evolve and their operations scale.
With the SOMS platform, research organizations can stay on top of critical trial metrics, improve team coordination, and reduce delays – paving 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:
Clinical Trial Management System (CTMS)
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 CTMS is purpose-built to empower clinical research sites to streamline all aspects of trial execution, including recruitment, CRC activities, finances, site management, and more.
eSource
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. Purpose-built to improve data accuracy, lower FDA audit risk, and reduce protocol deviations, RealTime-eSource boosts site efficiency, enabling coordinators to handle a greater volume of studies without compromising data quality or compliance.
eReg/eISF
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!
Boost participation and keep your research on track with RealTime-Engage! Including the MyStudyManagerTM participant portal and eConsent, Engage! offers tools to easily recruit, remind, and connect with participants for a smoother study experience.
Pay
Simplify the reimbursement process with secure, integrated digital payments for faster and more convenient payouts with RealTime-Pay.
Text
Improve participant communication by adding RealTime-Text into your CTMS across the globe. Text services many countries including the US, 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 enhances 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:
- Recruit patients faster with the powerful tools and integrations within CTMS and Engage!
- Manage studies more efficiently with automated workflows and centralized data across CTMS, eSource, and eReg/eISF
- Track finances more accurately with real-time reporting and automated billing functionalities within CTMS and Pay
- Improve communication and collaboration organization-wide with features embedded in each SOMS solution
- Make use of the RealTime Mobile App to access the SOMS suite of products anytime, anywhere
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
For research sites, the benefits of RealTime-SOMS extend far beyond simplified operations. SOMS enables research sites to handle larger study portfolios with greater ease and accuracy, making it possible to scale operations without compromising quality or compliance. Moreover, with access to real-time data, Principal Investigators, site managers and coordinators are better equipped to make proactive, data-based decisions that reduce trial delays, enhance recruitment strategies, and drive better overall outcomes.
In an era where efficiency and data quality are critical to success, SOMS provides the tools necessary for research sites to thrive. By centralizing study oversight and management into a single, streamlined platform, RealTime-SOMS helps clinical research organizations meet the demands of an increasingly complex industry with confidence, precision, and agility.
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 intelligence, and process and performance metrics.
