Electronic Data Capture (EDC) using edcpro

Our secure and 21 CFR Part 11-compliant edc system with its intuitive user interface is used to host your studies on-line.

Key benefits include rapid deployment, flexible study configuration for all phases of trials, comprehensive on-line data validation, rapid change management, and experienced user support. Our system and services ensure analysis-ready data at any time.

Our experienced group of Project Managers, Database Managers, Database Coordinators, Data Reviewers and System Administrators direct and maintain the entire EDC process for our clients. Their responsibilities include:

All project related personnel (Investigators, Coordinators, Monitors, CRAs, Data Reviewers, and Sponsors etc.) can easily navigate through all study data (CRFs and DCFs) and status reports with a standardized user-friendly interface. A customizable and robust workflow, combined with our data management SOPs seamlessly integrate all of the data management steps.

Our IT department will maintain and host the system, and manage a fully operational support desk. To ensure the highest level of security and maintain the functionality of EDC, we have designed our multi-layered network with multiple firewalls to mirror those of the banking industry. Our architecture ensures that only fully authenticated users are able to access our internal LAN. Our security protocols begin with controlled access to the premises, workstations and servers; followed by controlled access to the databases and systems over the Internet, intrusion detection, virus scanning at all ports of entry and concludes at document-level access control. Our EDC solution incorporates electronic signatures protected by digital signatures with all electronic documents transferred over the Internet using SSL 128 bit-encryption.