eClinArt is a robust web-based platform in which clinical data and trial information can be collected, managed and reported in a single, secure and easily accessible system. eClinArt provide full-set functions required in a Clinical Trial for both site study conductors and study management teams. It helps Pharmaceutical companies and CROs to automate and streamline their workflow processes which increases the visibility of related tasks and data in a clinical study. It also tracks, manages, and controls all clinical trials processes and tasks through a consolidated view and reports. As a result, all shareholders, including sponsors, senior management, trial managers, finance, clinical operations and regulatory affairs, have complete visibility into the current status of all trials, and related actions that are critical to the success of the program.

Through a secure, password-protected, web-based portal, this system centalizes all up-to-date and relevant study information, making it accessible on-line to all relevant parties including the Sponsor and the project team. This is used for both regional and global trials, with features that are specific to the region or to the entire trial. Information is easily tracked through a robust on-demand reporting feature that gives clients access to real-time data.

In addition to reducing costs and accelerating time to market, eClinArt has been designed, developed and implemented according to the most stringent regulatory requirements such as ICH, FDA 21 CFR Part 11 and the Guidance for Industry: Computerized Systems Used in Clinical Trials.

• Fully web-based and highly intuitive user-interface
• Simple and easy-to-use site interface improves data entry compliance
• Site interface requires only a browser; no hardware or software installation required
• User dash board and preferences
• Study and protocol management, design and tracking (epidemiology and longitudinal studies)
• Site status tracking
• Patient/CRF tracking, entry, and verification
• Site initiation visits, close-out visits, audits, and other visits
• Flexible data entry options
• Double Data Entry enabled
• Automated double data entry comparison and synchronization
• Electronic and manual discrepancy identification and automated data queries (ADQ) generation
• Paper and electronic CRF and document management
• Serious Adverse Event (SAE) collection, processing, reconciliation and reporting
• Robust query management capabilities (Automated and Manual)
• Automated edit checks and validation for compliances
• Easy controls to integrate medical coding references (MedDRA, WHO-Drug or Sponsor-developed)
• Customized Reporting for Sponsors, Project Manager, Investigators, Medical Monitors, CRA‘s, Data Managers
• Centralized Document Management System
• Investigator Payments Management and Tracking
• CRF Approval and Locking controls for Data Managers
• Centralized Document Management System
• Investigator Payments Management and Tracking
• CRF Approval and Locking controls for Data Managers
• Change control tracking supported with Audit Trials (Session, Navigation & Transaction)
• Sponsor module monitor real time trail related reports and progress
• Built-in email and notification controls for application users
• Compliance with HIPAA privacy and security guidelines including Title 21 CFR Part 11 and use of study-specific user roles and privileges, SSL encryption, de-identification of Protected Health Information (PHI), and auditing to monitor access and changes by users.
• Data import/export tools for migration of clinical datasets in ASCII, CSV, Excel spreadsheets, local databases and legacy data formats.