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Target e*CRF + e*Studio

Electronic data capture for designing, testing, and deploying clinical trials globally with customizable case report forms and 21 CFR Part 11 compliance.

Solution by Target Health
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Overview

Target e*CRF® and Target e*Studio® is a cloud-based Electronic Data Capture (EDC) solution developed by Target Health Inc., a full-service CRO and clinical trials software company. The platform is designed for CROs, pharmaceutical companies, and medical device companies of all sizes, enabling them to design, test, and deploy clinical studies globally while capturing, managing, and reporting clinical trial data electronically.

The solution combines the Target e*CRF application for study execution with Target e*Studio for study design, and is compliant with 21 CFR Part 11 requirements for electronic record systems. Average implementation time is under three months, and required user training averages one to two hours.

Core Application Modules

  • Target e*CRF Application — study design and execution environment tailored to clinical needs
  • Target e*CTR Viewer — direct data entry capability for clinical trial records
  • Target e*ICF™ (Electronic Informed Consent) — collects patient registration and consent online
  • ePRO (Mobile App) — enables direct data entry by patients via mobile device
  • IRT Module — supports randomization and investigational medicinal product (IMP) management
  • Target e*Pharmacovigilance — handles Serious Adverse Event (SAE) reporting and management
  • External Data Integration — supports data transfer to and from third-party systems

Platform Features and Capabilities

  • Role-based and user-based accessibility and data visibility controls
  • Subject multiple locks functionality
  • Communication tools between roles within the system
  • Customizable Case Report Forms (CRFs) and edit checks
  • Data exporting to extension studies
  • Support for both central and local laboratory data management
  • System-generated notifications
  • Protocol deviation tracking
  • Medical coding support
  • Remote Source Verification Documentation (SVD) via file upload and download
  • Randomization and unblinding capabilities
  • IMP management
  • Monitoring report generation
  • Data export in multiple formats: CSV, Excel, Text, and SAS Dataset

Compliance and Deployment

  • Compliant with 21 CFR Part 11, the federal mandate governing electronic record systems in clinical research
  • Delivered as a cloud-based platform, supporting global study deployment
  • Supports data transfer to third-party systems for interoperability with external platforms

Meta

Domain
Clinical Trial Management
Subdomain
Electronic Data Capture (EDC)
Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
BiotechCROMedical DevicesPharma
Development stage(s)
Clinical
Target user(s)
Research ScientistQA / Regulatory AffairsClinical / Diagnostic Professional
Compliance standard(s)
21 CFR Part 11