REALTIME EREG/EISF
Inspection-ready isn't a scramble. It's how you build your operating model.
Most organizations are still running studies on paper, creating unnecessary risk. Regulatory teams shouldn't have to chase signatures, search shared drives, or manually verify document versions.
RealTime eReg/eISF brings documents, workflows, signatures, and compliance tracking into one system, so your team always knows what's complete, missing, expiring, or needs attention.
Stay inspection-ready
Maintain complete, current regulatory files with audit trails, version histories, and document status visible at any time.
Reduce regulatory workload
Automate document routing, signature requests, expiration tracking, and recurring regulatory tasks instead of managing them manually.
Standardize regulatory operations
Create consistent folder structures, workflows, and document processes across studies, departments, and locations.
Catch compliance gaps earlier
See missing, expired, and outstanding documents before they become monitor requests, audit findings, or last-minute fire drills.
DOCUMENT MANAGEMENT & VERSION CONTROL
The right document. The right version. Every time.
Regulatory teams manage hundreds of documents across every active study. When those files live across shared drives, email, paper binders, or disconnected systems, finding a document is only half the problem. Your team also has to determine whether it's complete, approved, signed, and current.
Keep your regulatory files organized and controlled from creation through archival, with the document history and accountability required for clinical research built directly into the system.
- Organize regulatory documents using standardized eISF folder structures across studies.
- Maintain automatic version histories so teams can identify the current document without manually comparing files.
- Track document status, ownership, signatures, and completion from one place.
- Maintain complete audit trails showing document activity and changes over time.
- Search and retrieve study documents quickly for monitors, auditors, sponsors, and internal teams.
WORKFLOWS & ESIGNATURES
Stop chasing documents. Keep regulatory work moving.
A regulatory workflow shouldn't depend on someone remembering who needs to sign what, sending another follow-up email, or checking a spreadsheet to see what's still outstanding.
Automate the movement of regulatory documents through review, approval, and signature so the next step happens without your team manually pushing every document forward.
- Route documents to the appropriate users for review and approval.
- Send electronic signature requests directly through the platform.
- Track outstanding signatures and document status without separate follow-up logs.
- Maintain compliant electronic signatures and complete signature histories.
- Standardize recurring workflows so regulatory processes are executed consistently across studies and teams.
COMPLIANCE & INSPECTION READINESS
Know what's missing before someone asks for it.
Inspection readiness isn't about getting organized when an audit notification arrives. It's knowing the state of your regulatory files every day - which documents are current, which are expiring, which signatures are outstanding, and where compliance gaps exist.
RealTime eReg/eISF gives regulatory teams continuous visibility into document status and compliance so issues can be addressed as part of normal operations, not discovered during monitor visits or inspection preparation.
- Automatically track document expirations and alert your team when credentials, training, and other regulatory documents need to be renewed.
- See missing, incomplete, and outstanding regulatory documents across active studies.
- Version control so everyone works from the current document, always.
- Give monitors and auditors controlled access to the documentation they need.
- Supports 21 CFR Part 11, GCP, SOC 2, HIPAA, and GDPR compliant regulatory workflows with electronic records, signatures, and audit trails.
MONITOR & SPONSOR COLLABORATION
Give monitors what they need without creating more work for your team.
Every document request, status email, and on-site file review consumes regulatory team capacity. When monitors can’t access what they need directly, your team becomes the intermediary for information that’s already sitting in the regulatory file.
Give authorized monitors and sponsor teams secure, controlled access to study documentation so they can review what they need without relying on your team to retrieve and send every file.
- Manage monitor queries directly within the platform so questions, responses, and resolution history stay connected to the regulatory record.
- Provide role-based access to study documentation for authorized external users.
- Support remote document review and monitoring.
- Control exactly which studies, folders, and documents external users can access.
- Maintain visibility into external access and document activity through audit trails.
- Reduce the administrative burden associated with recurring monitor document requests.
CENTRALIZED REGULATORY MANAGEMENT & STANDARDIZATION
One regulatory standard across every study, team, and site.
As research expands, inconsistent folder structures, workflows, and tracking make regulatory oversight harder. RealTime eReg/eISF centralizes regulatory operations while giving each team the access and workflows they need.
Standardized workflows
Create consistent eISF structures and regulatory workflows across studies, teams, and locations.
Centralized compliance visibility
See what's complete, missing, expiring, or outstanding across studies without checking files individually.
Role-based access & control
Give regulatory teams, investigators, monitors, and other stakeholders the access they need while maintaining organization-wide standards.
Part of RealTime SOMS
Connect regulatory to the rest of your site operations.
RealTime eReg/eISF connects regulatory workflows with CTMS, eSource, Devana, SitePay, Text, Engage!, and more — keeping studies, teams, and operational data connected across one platform.
Built on results
Research Organizations Running on RealTime eReg/eISF
- Tekton Research
“During an FDA surveillance inspection of our site, the inspector was able to collect the required regulatory documents in less than an hour. And the inspector had no findings.”
Susan Bonner, BS, RPh, Regulatory Manager
Tekton Research
faster speed to inspection readiness vs. paper-based system
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x
FDA findings from an unannounced surveillance inspection
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for inspector to collect 300+ required documents
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hr
documents collected during inspection, fully accessible
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+
reduction in time spent on regulatory document management
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%
to collect signatures, down from 5 days
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hrs
clinical trials managed across all phases of research
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+
duplicate tasks after moving to a fully digital system
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- Coastal Pediatric Research
“With Complion, our coordinators achieved a 40% reduction in time spent on regulatory document management - time that can now be spent on recruitment and patient visits.”
Julia Brenner, MHA, Finance and Regulatory Manager
Coastal Pediatric Research