EDC / Clinical Trials
Electronic Data Capture System
EDC Core Features
- eCRF for remote data entry
- Configurable Edit Checks
- CRF reviewing for monitors
- Online Querying
- Following the inclusion of patients by site in real time by the monitor/sponsor
- Ability to use Double data entry
- 21 CFR Part 11 Compliance
- Responsive layout, works in Smartphones, Tablets and PCs
ITClinical's Electronic Data Capture (EDC) solution centralizes access to clinical trial's patient data. The ability to handle multiple clinical trials simultaneously makes it the central stop for clinical trial patient collection and retrieval.
A Phase I module boosts the base EDC solution with features that will increase work performance for Phase I CROs.
This tool is part of ITClinical's pharmaceutical portfolio and it incorporates the company's philosophy: making life easier for our partners.
By complying with regulatory requirements for electronic systems the EDC replaces paper based records.
- Collaborate online for faster feedback
- Access your data from anywhere
- Reduce overall clinical trial data management time
Platform Highlights & Deep-Dive Specifications
The eCRF framework functions as the core engine powering the EDC data pipelines.
The eCRF module is the central unit of the EDC system. It allows users to collect and manage subject data and export it securely (including in clean print-ready PDF format for the Trial Master File and statutory trial reports).
Powerful Edit Checks
Edit checks can be configured granularly per individual trial to issue automatic data-entry validation warnings or to conditionally show/hide complex data points when operational context demands it.
Online Integrated Queries
Issue and seamlessly reply to field anomalies right inside the interactive user views for rapid site cycle turnarounds. The audit-ready query workflow optimizes review timelines for monitors, principal investigators, and internal QA nodes alike.
Complete visual structural control over internal case report formatting schemas.
The Dynamic Case Report Form Editor Module is tailored specifically for CROs who require internal development autonomy over case design setup parameters.
If preferred, ITClinical's engineering team handles the structural implementation parameters end-to-end to launch configurations tailored directly to programmatic protocol directives.
Conditional Logic Trees
Establish context validation routines directly on any individual field node. Configure immediate rule behaviors to toggle follow-up questions, display input logic indicators, or flag outliers automatically during production runtime environments.
A reliable, electronic system foundation engineered for strict data safety criteria.
Fully certified architecture substituting traditional paper records securely with automated tracking protocols.
Complete Immutable Audit Trails
The engine captures, logs, and stamps every event change inside a system-wide unalterable reporting file, providing seamless operational visibility for data integrity checks.
Granular Access Permissions
A multi-tiered credential gateway structure safely matches functional site profile clearance constraints, minimizing data entry anomalies or transcription variances via authentic electronic source data capture.
Flexible architecture strategies matching any corporate framework roadmap cleanly.
ITClinical tailors infrastructure distributions to adapt directly to specific enterprise requirements without locking users into expensive, overhead-heavy setups.
Technology Infrastructure Flexibility
Choose an on-premises deployment to run the data collection modules over restricted internal network topologies, or opt for a securely managed, fully scalable Cloud SaaS instance.
Our secure cloud servers run entirely within enterprise-grade Linux topologies, keeping licensing fees at zero while maximizing platform uptime security.
Specialized workflows engineered for fast-paced Phase I testing conditions.
Early-phase environments run on ultra-tight life-cycle intervals. This acceleration module provides dedicated logic to capture metrics at rapid speed without sacrificing data integrity checks.
Global Variable Libraries
Package complete visual groupings into reusable configuration templates. Spin up subsequent matching sub-studies instantly inside the database module with single-click configurations.
Real-Time On-The-Ground Matrices
Map high-density temporal logs seamlessly during complex patient group draws where intervals are calculated down to seconds. Data entry views group clinical inputs chronologically by specific collection windows rather than individual profiles, enabling error-free workflow coordination right on the unit floor.