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eRegulatory

Electronic regulatory binder with document management, investigator site files, and digital delegation logs for clinical research compliance.

Solution by CRIO
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Overview

eRegulatory is an electronic regulatory binder solution from CRIO designed for clinical research sites. It is fully integrated with CRIO's eSource system and aims to replace paper-based regulatory processes by supporting compliance, collaboration, and oversight across studies.

The platform optimizes regulatory workflows and reduces administrative burden for site staff, including investigators, coordinators, and clinical research assistants. It is available for use across multiple geographic regions including the United States, Canada, Australia, and the European Union.

Training Document Management

  • Automates good clinical practice (GCP), International Air Transport Association (IATA), and other common filings into subsequent studies
  • Keeps credentials up to date through expiration alerts and document versioning

Electronic Investigator Site Files (eISFs)

  • Supports uploading, versioning, routing, and e-signing of regulatory documents
  • Allows configuration of study folders and saving of preferred folder structures as reusable templates
  • Tracks expiring documents, supports bulk signing of documents, and enables viewing and responding to clinical research assistant (CRA) queries

Digital Delegation Logs

  • Supports building electronic delegation of authority (eDOA) logs with the ability to copy duty profiles from one user to another
  • Tracks requested and delegated duties
  • Provides views of delegations organized by staff member
  • Supports downloading, printing, and tracking of eDOA logs

eRegulatory is part of the broader CRIO platform and integrates directly with CRIO's eSource system, supporting end-to-end regulatory document management within a single connected environment.

Meta

Domain
Clinical Trial Management
Subdomain
Site Operations & Regulatory Documents
Software type(s)
Record-Keeping System
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
PharmaBiotechCRO
Development stage(s)
Clinical
Target user(s)
QA / Regulatory AffairsClinical / Diagnostic Professional
Compliance standard(s)
21 CFR Part 11GxPICH