Partner Resource Portal

Site Operations Management System 

RealTime’s Site Operations Management System (SOMS) is 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. SOMS combines the power of several industry-leading tools to empower teams at every stage of the research process, including eSource, eRegulatory/eISF, SitePay, Text, Engage! participant portal and eConsent, and Devana business intelligence and analytics. 

With SOMS, sites can scale as they grow, stay on top of critical trial metrics, improve team coordination, and reduce delays.

Clinical Trial Management System 

[Organization Name] manages clinical trials using RealTime CTMS. 

A Clinical Trial Management System (CTMS) is a comprehensive software platform designed to manage various aspects of clinical trials at clinical research sites. This technology provides a centralized platform that assists site staff in optimizing the planning, execution, and management of clinical trials. 

RealTime CTMS streamlines various administrative and management tasks, reducing the reliance on manual processes and paperwork. Automating and centralizing administrative tasks reduces manual errors and time spent on clerical burdens, freeing site staff to focus more on patient-focused activities. Features include patient management, coordinator task management, document management, financial management, and advanced reporting.  

RealTime CTMS complies with industry regulations such as FDA 21 CFR Part 11, GDPR, HIPAA, and other global regulations. 

Benefits of Using a CTMS 

• Streamlined Study Management: RealTime CTMS provides robust technology for managing all aspects of clinical trials, from participant recruitment and enrollment to data collection and study closure. Elimination of paper-based processes allows investigators and site staff to spend more time on participant care, resulting in improved oversight and accelerated overall trial progress. 

• Financial Management: The platform offers tools for budgeting, financial tracking, and accounting, which are essential for maintaining financial transparency and control over a trial’s budget. Using a CTMS can reduce unnecessary expenses through efficient resource management. It enables better planning and utilization of resources, including staff and budget, which leads to more cost-effective trial management.   

• Reporting and Analytics: The system provides robust reporting tools and analytics, offering insights into trial performance and facilitating data-driven decision-making. This capability is crucial for making timely decisions based on current data trends and trial progress.  

• Improved Participant Recruitment and Retention: RealTime CTMS allows for more effective participant management, including recruitment tracking, appointment scheduling, and communications. These features help in maintaining participant engagement and minimizing drop-out rates. It also aids in managing participant recruitment, screening, enrollment, and follow-ups, thereby improving participant engagement and retention rates.  

• 24/7 Remote Access: Featuring a web-based program and a mobile app, RealTime CTMS provides 24/7 online access, allowing research staff and monitors to collaborate more effectively during the study. The research site can grant access to study records at any time during or after the study. This portal can also be used to facilitate monitoring activities, sponsor audits, and regulatory inspections.

• End-to-End Technology Infrastructure: RealTime CTMS features website integration, a mobile app, API connections, and several partner software integrations. The CTMS is also part of RealTime’s Site Operations Management System (SOMS), which provides a bundled suite of integrated solutions, including eSource, eRegulatory/eISF, Pay, Text, Engage! participant portal and eConsent, and Devana business intelligence and analytics.

eSource 

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, eSource boosts site efficiency, enabling coordinators to handle a greater volume of studies without compromising data quality or compliance. 

Benefits of Using RealTime eSource 

• Automate data capture, eliminating manual entry and saving valuable time 

• Sign documents electronically, no printing needed 

• Built-in data validation to help ensure data accuracy 

• Track data changes with real-time audit trails 

• Strict adherence to privacy and security regulations, including Part 11 and GDPR compliance 

eRegulatory/eISF 

RealTime eReg/eISF is a user-friendly document management and electronic regulatory (eReg)/electronic Investigator Site File (eISF) system built for clinical research sites. With RealTime eReg/eISF, research organizations can simplify document management, storage, retrieval, and collaboration across site teams or departments.

Benefits of Using RealTime eReg/eISF 

• Securely store documents electronically, ditching bulky folders and physical storage 

• 24/7 instant access to files from any device – anywhere, anytime 

• Streamlined workflows for faster study execution 

• Securely collaborate with colleagues and monitors using built-in query management system 

• Automatically track document revisions 

• Advanced search functionality 

• Part 11, GCP, SOC2, HIPAA, and GDPR compliant 

Participant Payments 

RealTime SitePay simplifies the reimbursement process with secure, integrated digital payments for faster and more convenient payouts. SitePay ensures participants receive prompt reimbursements for increased satisfaction and a higher likelihood of continued trial participation. 

Benefits of Using RealTime SitePay 

• Enable fast electronic payments for swift reimbursements 

• Protect financial information with secure digital transactions 

• Mobile app’s patient portal provides 24/7 access for patients to view their transaction history, manage their PIN for secure transactions, and even transfer funds 

• Configure automatic text and email notifications to participants 

• Generate detailed reports based on study, date range, participant, or site 

Text/SMS Messaging 

RealTime Text improves participant communication by adding texting capabilities into your CTMS. Text is available in many countries across the globe, including the US, Canada, Australia, Europe, and New Zealand. Text helps you reach the right people for your research efficiently, saving valuable time and resources. 

Benefits of Using RealTime Text 

• Send and receive SMS messages directly with patients and track communication on their patient profile 

• Automate appointment reminders and responses to capture confirmations and notify staff 

• Recruitment-related text messages are sent via short code in the US to ensure FCC compliance and enable mass messaging to thousands of subjects 

Participant Portal and eConsent 

RealTime Engage! boosts participation and keeps your research on track. Engage! includes the MyStudyManagerTM participant portal and eConsent, offering tools to easily recruit, remind, and connect with participants for a smoother study experience.

Benefits of Using RealTime Engage! 

• Streamline consent processes and eliminate paperwork with secure eSignatures 

• Automated visit notifications help patients remember what they need to do, reducing dropout rates 

• Convenient communication via mobile app and text makes participation easier and less time consuming for subjects 

• Offer flexible options like virtual visits for wider research reach 

• Simplify recruitment for future studies by nurturing positive participant experiences within your existing system 

Business Intelligence and Analytics 

RealTime Devana is a holistic business intelligence platform designed specifically for research site organizations, driving transparency and accountability across all functional groups. From pipeline management and streamlined study start-up through to historical trial metrics, Devana provides one source of truth for all your clinical trial data and processes. 

Benefits of Using RealTime Devana 

• Track and monitor new trial leads from CROs and sponsors to build and develop your study pipeline 

• Standardize and streamline study start-up workflows with intelligent automation 

• Store all trial-related contacts and documents in one secure place 

• Capture overall timing and performance metrics both within Devana and via integrations with other systems such as CTMS, allowing for full-cycle data display and analysis 

• Powerful dashboards and reports make it easy to share insights and historic data with CROs and sponsors, helping win more opportunities based on your organization’s past accomplishments