A cloud-based imaging-enabled EDC system improving workflow, compliance, data quality and image accessibility in clinical trials

The EDCIQ solution incorporates the workflow, features and functions for any drug, biologic or medical device clinical trial leveraging medical imaging. It seamlessly integrates data and image collection, image viewing and QA, image/data processing and analysis, documentation, reporting, data management, storage and export. Moreover, it is all in a unified, secure, easy-to-use, zero-software, web-based platform that supports your regulatory and clinical data management efforts.

EDC Plus Chart

WORKFLOW

EDCIQ leverages ImageIQ’s unique experience in imaging analytics, clinical research, data management biomedical software engineering and the latest in web-based image viewing and image-management technologies. EDCIQ saves time and costs, facilitates study site user compliance and simplifies clinical data and trial stakeholder management with these benefits:

Accessible

  • Provides reliable access to imaging data and workflow status for study sites, CROs, image readers, biostatisticians, auditors, clinical data managers and sponsors.
  • Configurable to restrict access, features and functions by individual user or user category
  • Multi-lingual formatting and support
  • Seamless integration and reporting of images, image data and clinical data


Flexible

  • Configurable EDCIQ with automated software-based image analysis specific to your study.
  • Designed to support any imaging modality or image format (e.g., DICOM, TIFF, AVI, etc.)
  • Configurable electronic case report forms (eCRFs) for data/image upload and image evaluation
  • Integrated 2D / 3D image viewers provide standardized image evaluation environment for all expert image readers and image QA personnel
  • Data export can before formatted (e.g., SAS, .CVC, etc.) to facilitate subsequent database upload and/or statistical analysis
  • Easy to deploy and use


Imaging Empowered

  • Data and image upload
  • Integrated image QA, prior to image evaluation by image reader
  • Integrated 2D/3D image viewer supporting any image format
  • Provides both manual and automated image reading and quantitative measurement tools for image readers
  • Delivers automated imaging analytics, tailored to unique study needs
  • Manages, stores and archives images


Compliance Supportive

  • Meets data security, 21 CFR Part 11 and the International Data Safe Harbor Privacy regulatory compliance requirements
  • Full audit trail, and configurable to specific audit requirements
  • Audit trail is end-user facing for informed and quick decision making


Cost-effective

  • Eliminates trial operational redundancies and human errors that waste time and money
  • Minimal setup, validation and deployment time and cost


Secure and IT-friendly

  • Ensures data safety and integrity via encryption and configurable administrative and security controls
  • Interfaces with commercially available databases, clinical trial management systems (CTMS) and non-imaging enabled EDCs
  • Zero software installation is required


Data Driven and Focused

  • Ensures data and image collection, transfer, management, and storage compliance and consistency across all study sites
  • Allows stakeholders to manage and monitor workflow compliance and data integrity for every patient, study site and time point
  • Redundancies for data storage and archive to prevent data loss


Administratively Simple

  • Eases study site qualification and oversight burden
  • Supports smoother more efficient audits
  • Enhances study site compliance and satisfaction
  • Configurable, stakeholder-specific experience avoids confusion, human errors and high training costs


EDCIQ provides a single unified system of truth for everyone involved in clinical trial imaging – CRO, study sites, image readers, biostatisticians, auditors, clinical data managers and sponsors

EDC Plus Logo

Our cloud-based imaging EDC system enables clinical trial and data managers to automate, monitor, manage and report on all of their clinical trial imaging workflow and activities, via seamless integration of image, image data and clinical data.

 

Electronic Data Capture Case Study

 


EDCiqDerm
NEW! Integrates mobile imaging and imaging-enabled EDC for Dermatology and Wound Healing Clinical Trials

LEARN MORE