Electronic Research Information and Compliance (eRIC)
An Institutional Review Board (IRB) / Independent Ethics Committee (IEC) is a group that has been formally designated to review and monitor biomedical and behavioral research involving human subjects. In the Unites States, IRBs are mandated by Title 45 CFR Part 46.

Wipro’s solution eRIC is a paperless, electronic IRB solution that facilitates protocol submission, tracking and reviewing the scientific, regulatory and compliance information required for the safe conduct of human subjects research.

eRIC is a single source collaboration platform supported by the low-cost administrative capabilities. This feature greatly improves the efficiencies of regulatory activities and research practices.

Functional capabilities of eRIC include:

• Protocol management
• Meeting management
• Document management and review
• Reporting
• IRB office task facilitation

Regulated Document Management Solution (RDMS)
Wipro’s Regulated Document Management System (RDMS) helps companies to streamline the document management processes while maintaining the tracking, auditing and workflow controls necessary for compliance.

Features of RDMS:

• Information Rights Management (IRM)
• Role-based security (views and access control)
• Custom notifications and custom workflows
• Versioning and detailed history for auditing purposes
• Central document repository
• Digital signatures

Benefits from eCTD:

• Modular system architecture to perform updates to the submission without disturbing the entire system
• Streamlined and seamless eCTD publishing
• Build the XML backbone and other eCTD components with transparent user interface
• Adaptable to various regional standards
• Follows ICH guidelines for eCTD submission and 21CFR Part 11 regulation