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EDC & Clinical Data Management

Structured data capture and outcome measurement for clinical research, case management, and patient-centered care.

Solution by QuesGen Systems
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Overview

QuesGen EDC & Clinical Data Management is a module within the QuesGen Systems platform, designed to support structured data capture for complex clinical research studies and programs. It is suited for organizations running multi-site studies, population health programs, or patient-centered care initiatives that require longitudinal follow-up, data quality controls, and audit-ready reporting.

QuesGen positions its EDC and data management capabilities as part of a broader outcome-driven workflow, where planning, tracking, and outcomes measurement operate together on a single platform rather than as disconnected tools.

Core EDC & Clinical Data Management Features

  • Flexible data models that can be configured to match study or program requirements
  • An assessments library for building and reusing structured data collection instruments
  • Role-based access controls and workflow management to govern who can view, enter, or modify data
  • Support for longitudinal follow-up across study participants or program enrollees
  • Data quality tools to maintain integrity throughout the data lifecycle
  • Exports and reporting outputs aligned to both analysis and operational needs
  • Audit-ready reporting to support compliance and review processes

Related Platform Capabilities

  • Electronic Patient Reported Outcomes (ePRO) via mobile-friendly surveys and check-ins, with optional scheduled prompts and reminders, and outcome views that connect PRO data to care plans
  • Research surveys and questionnaires with reusable instruments, versioning, validation logic, required-field controls, and alignment to outcomes reporting
  • Assessments that align with data models, protocol requirements, and reporting needs

Integrations and Data Exchange

  • APIs to enable data exchange with upstream and downstream systems
  • Repository support designed for structured export and data curation workflows
  • Integration approach intended to allow data movement without compromising governance requirements

QuesGen is built to support complex workflows across clinical research, case management, and patient-centered services. The platform is designed so that EDC, ePRO, and survey capabilities can be combined without losing coherence across the overall data and outcomes workflow.

Meta

Domain
Clinical Trial Management
Subdomain
Electronic Data Capture (EDC)
Software type(s)
Record-Keeping System
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
Academic / ResearchBiotechCROPharma
Development stage(s)
ClinicalPost-Market & RWE
Target user(s)
Research ScientistQA / Regulatory AffairsClinical / Diagnostic ProfessionalIT / Systems Admin / Data Engineer
Compliance standard(s)
21 CFR Part 11