Imagine building a clinical trial solution
tailored precisely to your needs.
One that grows and scales effortlessly with your business. At RealTime, our Site Operations Management System (SOMS) is designed to be the ideal eClinical suite, seamlessly adapting to the demands of your clinical trials. Each product in the SOMS suite—CTMS, eSource, eReg/eISF, Pay, Engage!, Text, and more—works together in perfect unison, creating a streamlined, end-to-end solution that evolves with you. With SOMS, you gain a partner in progress, ensuring every aspect of your trials runs smoothly as your business expands.
CTMS (Clinical Trial Management System)
Track Financials: Manage and track revenue, costs, and profitability. Build budget templates based on study event schedules and create/send invoices.
Recruit Participants: Identify qualified participants using participant matching based on criteria like age, gender, medical conditions, and integrate advertising tracking.
Access Reports: Real-time access to financials, recruitment reporting, operational and custom reports.
Secure Hosting: HIPAA-compliant architecture, FDA Part 11 Compliant, SOC 2 Certified, enterprise-class data encryption, and optional multi-factor authentication.
Automated alerts for expirations: Stay on top of important deadlines with proactive notifications to avoid non-compliance.
eSource
Electronic Data Collection: Create reusable form templates, track visits, upload reports, and perform electronic assessments. Standardize documents and ensure data accuracy with protocol compliance checks.
Platform Integration: Link eSource data with CTMS for financial tracking, integrate eSource with participant charts, and speed up study start times using eConsent.
eReg / eISF
Document Management: Standardize and securely store eRegulatory binders. Unlimited users and storage, ensuring inspection readiness and compliance with Part-11 and HIPAA.
Compliance and Efficiency: Facilitates electronic signatures, document grouping, and regulatory workflows. Mobile access allows for document management and signatures on the go.
Inspection Readiness: Stay audit-ready at all times with fully electronic binders, ensuring rapid and secure access during inspections and audits.
Collaboration: Enable seamless collaboration with CROs, sponsors, and auditors, reducing manual oversight and enabling remote monitoring and query resolution.
Pay
Participant Payments: Instant payment to participants via a secure Pay card. Participants receive real-time notifications and have access to their account through a convenient portal.
Fraud Prevention: Prevent fraud by eliminating paper checks and potential bank account security risks, ensuring that payments are fast, secure, and trackable.
Convenient Transfers: Participants can transfer funds from their Pay card directly to their personal bank accounts, providing flexibility and ease of use.
Text
Participant Recruitment: Mass texting for participant matching and recruitment notifications. Participants can respond to show interest, and responses flow into RealTime-CTMS for immediate follow-up.
Appointment Reminders: Automated reminders 24 hours prior to study visits, with responses tracked in RealTime-CTMS.
Regulatory Compliance: Ensure all communication is compliant with FCC regulations and HIPAA, providing a secure and reliable messaging solution for participants.
Engage!
Participant Engagement: Engage participants through the MyStudyManager™ portal for eConsent, visit schedules, virtual visits, study tasks, notifications, and stipend balances.
eConsent: Facilitates electronic signatures through the MyStudyManager™ mobile app or desktop portal. Signed consents are auto-filed for participant access.
