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Remote Monitoring

21 CFR Part 11 compliant remote document verification and management for centralized clinical trial monitoring, with secure site portal and mobile submission.

Solution by Trial Interactive
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Overview

Trial Interactive's Remote Monitoring is a 21 CFR Part 11 compliant electronic Investigator Site File (eISF) and Site Portal designed to support centralized and remote clinical trial operations. Built for Clinical Research Associates (CRAs), site personnel, and study teams, it provides a secure, streamlined environment for remote document verification, essential document review, and source data management — reducing the need for on-site visits while maintaining regulatory compliance.

The platform addresses the most common operational challenges of remote monitoring, including secure site access, document submission workflows, and CRA review efficiency. With mobile app support, automated filing capabilities, and round-the-clock help desk availability, Trial Interactive Remote Monitoring is suited for sponsors, CROs, and site teams looking to modernize and centralize their clinical trial management processes.

Core Remote Monitoring Capabilities

  • Simple site-facing solution for study-related document collection and review
  • Facilitation and documentation of essential document and remote source data verification (SDV) activities
  • Configurable, separate folders for content containing Protected Health Information (PHI)
  • Document de-identification and redaction tools to protect PHI
  • Multiple site access from a single location with controlled, site-specific document permissions
  • 24/7 help desk support via email and phone

Site Personnel Document Submission

  • Dedicated study email address for sending documents directly to the portal inbox
  • iOS and Android mobile app (myTI) enabling site staff to scan and upload documents directly to the study portal
  • Controlled direct upload access ensuring site personnel can only view their respective Site Files

Key Challenges Addressed

  • Submission and management of site documentation in a centralized portal
  • Secure, role-based access provisioning for site personnel
  • Simplified CRA review through mobile reconciliation workflows
  • Automated filing and naming of incoming documents
  • Electronic signature support with automatic eSignature functionality

Trial Interactive Remote Monitoring is designed to reduce travel time and costs for study personnel while maintaining compliance with 21 CFR Part 11 requirements. The platform supports remote trial management best practices and is backed by educational resources including webinars and quick-start guides developed in collaboration with industry partners such as MANA RBM.

Meta

Domain
Clinical Trial Management
Subdomain
Clinical Trial Management Systems (CTMS) & eTMF
Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
PharmaBiotechCRO
Development stage(s)
Clinical
Target user(s)
QA / Regulatory AffairsClinical / Diagnostic ProfessionalIT / Systems Admin / Data Engineer
Compliance standard(s)
21 CFR Part 11GxPHIPAA