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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

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