The Client
A leading US based Medical center and Research Institute that is involved in human subjects’ research.
Challenge
- Paper-based manual process for protocol application submission and tracking
- Complexity in handling IRB tasks
- Strict security and privacy requirements in the process
- Time consuming protocol application review process
- Administrative workload and paperwork
- Complexity in review processes by multiple stakeholders
- Redundancy and human errors
- Streamline meeting logistics
- Maintain audit trail and change control
- Complexity in procuring subjects consent to trial participation
Solution
Wipro implemented eRIC solution, a single-source collaboration platform which is designed for caBIG bronze level, 21 CFR 11 and 45 CFR 46 compliance. The solution supported:
- Web; it was built on open source technology
- Electronic submission of protocol applications and approvals
- Integrated management reporting and other ‘ad hoc’ and ‘pre-formatted’ reporting
- Management of the protocol application questions by a ‘user administrator
- One-stop shop for submitting one protocol application to multiple stakeholder committees through proprietary FormSelector™ technology
- Smart informed consent generation, storage, version tracking, and version comparison
- Audit trail and audit history
Benefits
The solution greatly improved the efficiencies of regulatory activities and research practices within a research organization by providing a single source web-based solution and system driven meeting / review facilitation.
eRIC has significantly reduced administration burden, simplified protocol review processes, and ensures that ethical standards and regulatory compliance needs are met.
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