RealTime eClinical Solutions provides the industry’s most complete Site Operations Management System (SOMS), purpose-built to streamline clinical research operations across sites, site networks, AMCs, health systems, sponsors, and CROs. This FAQ addresses the most commonly asked questions by operational, regulatory, financial, IT, and executive teams evaluating our platform.
General Platform
Q: Why choose RealTime instead of piecing together multiple vendors?
A: Multiple systems mean more complexity, higher costs, and constant reconciliation. RealTime unifies CTMS, eSource, eReg/eISF, Pay, Text, participant engagement, Devana, and mobile capabilities into one integrated ecosystem. This reduces system management, improves compliance, and ensures a single source of truth across your entire operation.
Q: How does RealTime help sites save staff hours?
A: By centralizing workflows and eliminating duplicate entry, sites typically report a ~29% weekly reduction in coordinator workload. Automation in study start-up, scheduling, data capture, regulatory management, and payments frees staff for higher-value work.
Q: Is the RealTime platform scalable for AMCs, health systems, and large site networks?
A: Yes. RealTime is built for enterprise-scale organizations. Multi-site hierarchy controls support expansion from single research units to large multi-hospital systems.
Q: Does RealTime support decentralized and hybrid trials?
A: Yes. RealTime’s suite of eClinical solutions, including access to the RealTime Mobile App, support remote documentation, virtual visits, remote consent, and hybrid workflows without compromising data integrity.
SOMS (Site Operations Management System)
Q: What is a Site Operations Management System (SOMS)?
A: SOMS is RealTime’s centralized, fully integrated eClinical suite that consolidates critical site operations into one platform:
- CTMS
- eSource + EDC Connect
- eReg/eISF
- Engage! (MyParticipantManager Participant Portal + eConsent)
- Pay
- Text
- Devana
- Mobile App
Q: What ROI can organizations expect from SOMS?
A: Measurable benefits from RealTime’s SOMS platform include:
- Faster study start-up
- Higher enrollment throughput
- Fewer missed payments and billing gaps
- Reduced administrative burden
- Stronger sponsor confidence and more awarded trials
Q: Is SOMS compliant with FDA 21 CFR Part 11 and HIPAA?
A: Yes. SOMS is fully compliant with 21 CFR Part 11, HIPAA, GDPR, and ICH-GCP, with full audit trails, e-signatures, and enterprise security controls.
CTMS
Q: What does RealTime-CTMS manage?
A: Scheduling, study tracking, coordinator task management, recruitment workflows, financials, invoicing, receivables, reporting, and full portfolio oversight. It replaces spreadsheets, email chains, and manual reconciliation.
Q: What is a CTMS and why does my site need one?
A: A Clinical Trial Management System (CTMS) organizes every aspect of site operations—scheduling, task management, finances, recruitment, and reporting. RealTime-CTMS eliminates the inefficiencies of spreadsheets and paper, helping sites run faster and smarter.
Q: How does CTMS help with financial management?
A: RealTime–CTMS tracks every receivable tied to subject visits, procedures, invoices, and milestones, reducing lost revenue and accelerating payment cycles.
Q: Is RealTime an enterprise-grade CTMS?
A: Yes. RealTime-CTMS is trusted by leading academic medical centers, hospitals, health systems, and multi-site networks. Its enterprise-grade design delivers centralized governance, audit-readiness, advanced reporting, and scalability to support even the most complex organizations.
Q: What ROI can sites expect from RealTime-CTMS?
A: Clients report significant time savings, faster invoicing, and recovered revenue that would have otherwise been lost.
Q: How does RealTime-CTMS save coordinators and staff time?
A: RealTime’s CTMS automates scheduling, visit tracking, and task assignments, while linking directly to subject data and financials. Sites typically report saving dozens of coordinator hours per study by reducing manual entry and rework.
Financials
Q: Will RealTime improve revenue capture?
A: Yes. Sites using RealTime-CTMS report recovering missed revenue, reducing payment delays, and improving financial oversight.
Q: Can a CTMS help us track sponsor payments, site revenue, and reduce missed revenue?
A: Yes. RealTime-CTMS tracks every receivable in real time, flagging unpaid invoices and reconciling sponsor payments. This ensures your site captures all earned revenue without delays or lost invoices.
Q: How does RealTime manage site payments?
A: RealTime–Pay automates stipends, mileage, and visit reimbursements to patients while linking seamlessly to CTMS financial data for accurate sponsor invoicing and tax reporting.
eSource
Q: How does eSource improve data quality?
A: RealTime-eSource enforces ALCOA+ principles and ensures:
- Real-time, contemporaneous documentation
- Fewer transcription errors
- Remote monitoring
- Protocol-driven workflows and edit checks
- Complete audit trails
Q: Can RealTime build our eSource templates?
A: Yes. Our Template Building Services provide validated, protocol-aligned templates with embedded logic and study-specific guardrails.
Q: What’s the ROI of switching to RealTime-eSource?
A: Sites using RealTime eSource consistently report:
- Time savings of 50%+ compared to paper or transcription-heavy workflows
- Fewer protocol deviations
- Higher coordinator productivity
- Improved monitoring efficiency
- Faster query resolution
- Sponsor reimbursement for eSource (common in oncology, vaccine, and high-complexity trials)
- Increased coordinator ability to handle more studies
Q: What is EDC Connect (eSource to EDC)?
A: EDC Connect is RealTime’s breakthrough feature that eliminates duplicate data entry by exporting eSource data directly into any ODM-compatible EDC. No custom integrations, no transcription, no data re-entry from eSource to EDC.
Q: How does RealTime’s EDC Connect work?
A: EDC Connect uses a standards-based workflow (ODM) to eliminate duplicate data entry and ensure clean, structured data moves directly from eSource to EDC. The process is simple:
- Sponsor provides ODM metadata
- Site uploads it into RealTime-eSource
- RealTime auto-maps visit data
- Sites export clean, structured data into the EDC
Q: What are the benefits of EDC Connect?
A: EDC Connect delivers a measurable operational lift for both sites and sponsors by enabling standards-based data flow from eSource to EDC. Key benefits include:
- Eliminate duplicate entry
- Major error reduction
- Faster data delivery and reconciliation
- Fewer queries
- Improved audit confidence
eReg / eISF
Q: What’s the difference between an eReg and an eISF platform?
A: They are often used interchangeably, but technically:
- eReg refers to electronic regulatory workflows (collection, routing, signatures).
- eISF is the complete electronic Investigator Site File that houses all essential documents.
RealTime provides both — a single system that manages the entire regulatory workflow and maintains a fully compliant electronic binder structure.
Q: What makes RealTime-eReg/eISF different from generic document-storage tools?
A: Unlike generic file-sharing systems, RealTime’s eReg/eISF is purpose-built for regulatory compliance. It delivers controlled document workflows, audit trails, version tracking, electronic delegation logs, training attestations, and inspector-ready structure.
Q: Is RealTime-eReg/eISF validated and compliant with 21 CFR Part 11 and ICH-GCP?
A: Absolutely. RealTime’s eReg/eISF supports audit trails, e-signatures, controlled workflows, secure permissions, and validated infrastructure — meeting FDA, HIPAA, GDPR, ICH-GCP, and ALCOA+ requirements.
Q: How does RealTime eReg/eISF support inspection readiness?
A: RealTime’s eReg/eISF centralizes all regulatory documents, automatically manages version control, logs every user action, and maintains a complete history of approvals and signatures. Sites routinely report being “inspection ready at all times,” with FDA, IRB, and sponsor monitors accessing documents through secure portals.
Q: Can sponsors and CROs access our eISF for remote monitoring?
A: Yes. RealTime’s eReg/eISF offers secure, permission-based sponsor/CRO access, allowing monitors to review documents remotely without burdening site staff. This reduces visit preparation time and improves collaboration.
Q: Does the system maintain a compliant Delegation of Authority (DOA) log?
A: Yes. RealTime’s eReg/eISF provides a controlled DOA module with electronic signatures, role tracking, automatic updates, and version history — eliminating paper DOA discrepancies that commonly drive audit findings.
Q: How does RealTime eReg/eISF integrate with CTMS and eSource workflows?
A: RealTime’s unified SOMS ecosystem connects regulatory documents to study builds, subject data, scheduling, and operations. This ensures regulatory readiness is aligned with study activation and ongoing conduct.
Q: Can RealTime migrate our existing paper or electronic binders?
A: Yes. RealTime Professional Services can migrate regulatory files from paper, shared drives, or other eReg systems and rebuild them into compliant electronic binders with proper structure, versioning, and metadata.
Q: What ROI can we expect from moving to RealTime’s eReg/eISF?
A: Using RealTime’s eReg/eISF solutions, organizations typically see:
- 5x faster monitor prep
- 2-3x reduction in regulatory delays
- Fewer audit findings related to document control
- Eliminated binder maintenance overhead
- Reduced time spent chasing signatures and re-certifications
Q: How does RealTime ensure that staff complete required training before performing study tasks?
A: RealTime’s eReg/eISF solutions link staff credentials, training records, and role assignments directly to DOA workflows, ensuring individuals cannot be delegated until all required documents and certifications are complete.
Q: Can eReg/eISF support multi-department or enterprise-level research programs?
A: Yes. RealTime’s eReg/eISF is built for complex organizations with multiple research groups, specialties, or hospitals. It supports enterprise governance, binder templates, central monitoring, and standardized workflows across all departments.
Q: How does RealTime handle IRB documentation and regulatory correspondence?
A: IRB approvals, continuing reviews, safety letters, amendments, and correspondence can be uploaded, routed, tracked, and version-controlled within the system — and made available instantly to monitors.
Patient Recruitment & Engagement
Q: How does RealTime help with patient recruitment?
A: RealTime-CTMS includes a powerful recruitment and patient management system that helps sites identify, contact, and enroll participants faster. With features like Web Integration, advanced filtering, recruitment lists, text and email outreach, referral tracking, and automated follow-up tools, sites can streamline recruitment workflows and engage qualified participants more efficiently. Sites report up to 160% increases in enrollment after centralizing recruitment workflows.
Q: What is RealTime-Text?
A: RealTime Text automates patient reminders, visit confirmations, and study updates to reduce no-shows and improve retention.
Q: What is Engage! and how does it work?
A: RealTime Engage! combines a powerful Participant Portal (MyStudyManager™) with eConsent to simplify enrollment and keep participants engaged throughout the study. The MyStudyManager portal gives participants a mobile-friendly hub for visit schedules, questionnaires, notifications, virtual visits, and stipend/pay tracking.
Meanwhile, the eConsent component enables remote, 21 CFR Part 11-compliant consent via desktop or mobile — speeding enrollment and improving compliance. Together, these solutions help sites boost recruitment, improve retention, reduce no-shows, and drive better study outcomes.
Professional Services
Q: What can RealTime’s Professional Services do for us?
A: Our team accelerates adoption, optimizes workflows, builds eSource and study templates, performs compliance gap analyses, completes financial reconciliations, and delivers live instructor-led training — all to ensure your system and processes are aligned with industry best practices.
Q: What are the benefits of using RealTime Professional Services?
A: RealTime Professional Services delivers measurable ROI by accelerating system adoption, improving workflow efficiency, and reducing the internal time and labor required to configure and maintain studies. Sites see faster start-up timelines, fewer errors, optimized templates and study builds, and higher utilization of RealTime’s products.
Q: Can RealTime customize study templates and eSource forms to reduce rework?
A: Yes. Our tailored templates are designed to match your exact study protocols, cutting down on rework, preventing deviations, and improving inspection readiness.
Q: How does a gap analysis from RealTime improve compliance and efficiency?
A: A gap analysis conducted by RealTime’s in-house consultants identifies where your processes or technology are slowing you down or putting compliance at risk, then provides a clear action plan to increase efficiency and protect against audit findings.
Compliance & Security
Q: Is the RealTime platform compliant with regulatory requirements?
A: Yes. RealTime complies with:
- FDA 21 CFR Part 11
- HIPAA
- GDPR
- ICH-GCP
- ALCOA+ principles
Q: How does RealTime protect patient data?
A: RealTime eClinical Solutions uses enterprise-grade encryption, secure hosting, and role-based access controls to safeguard sensitive trial and patient data.
Integrations & Interoperability
Q: Does RealTime have APIs that integrate with our existing systems?
A: Yes. RealTime supports a robust API framework that allows secure integration with CRM, ERP, EMR/EHR, analytics/BI platforms, and other internal systems — giving sites a secure, scalable way to connect clinical-trial data to an existing infrastructure.
Q: Will RealTime simplify our tech stack?
A: Yes. By consolidating CTMS, eSource, eReg/eISF, Pay, Text, participant engagement, and other core tools into one unified platform (SOMS), RealTime makes it possible for organizations to retire multiple standalone systems and eliminate redundant workflows. Most organizations retire 3–8 legacy systems after adopting SOMS.
Sponsors & CROs
Q: Do sponsors accept RealTime’s site-based platforms?
A: Yes. RealTime’s site-based platforms, including eSource and eReg/eISF, are widely accepted by global sponsors and CROs for use in regulated clinical trials across therapeutic areas and study phases.
Q: Can RealTime platforms be actively deployed in sponsor- and CRO-managed studies?
A: Yes. RealTime’s platforms are and can actively be deployed as part of sponsor- and CRO-managed studies. This supports day-to-day site operations, compliant data capture, remote monitoring, and collaboration between sites, sponsors, and CRO teams.
Q: Can sponsors access the system for oversight and monitoring?
A: Yes. RealTime is widely accepted by major CROs and global sponsors for remote monitoring, source data review, and regulatory document management across therapeutic areas and study phases.
Q: Can sponsors and CROs access RealTime systems directly?
A: Yes. Secure sponsor and CRO access enables real-time visibility into study progress, remote monitoring activities, document review, and performance oversight—without disrupting site workflows.
Q: How does RealTime support sponsors and CROs in site selection?
A: Devana + TrialAlign provides unbiased, real-time site performance metrics and patient access insights, enabling precise, data-driven site selection.
Pricing & ROI
Q: How much does RealTime cost?
A: See more details for RealTime eClinical Solutions pricing here.
Q: What ROI can sites expect from RealTime?
A: According to case studies featured by RealTime:
- One hospital system reported 28x growth in visit volume after adopting eSource.
- Across sites using the full SOMS platform, key operational gains include:
- ~29% staff time savings per week thanks to streamlined workflows.
- 2x coordinator capacity — meaning each coordinator could handle about twice the number of studies.
- 5x faster inspection readiness, enabled by built-in audit trails and version control
- 76% reduced contract and budget turnaround time
- 40% increased revenue growth resulting from faster study activation and higher throughput.
Q: Does RealTime offer ongoing support to maximize long-term ROI?
A: Absolutely. RealTime’s Professional Services team continues to offer access to a suite of consultant services to help users improve platform performance long after implementation.