Traditional research compliance systems create fragmentation, making reports that should be easily accessible difficult to find when needed.
Audits from OHRP, FDA, USDA, NIH, AAALAC, AAHRPP, and sponsors require unique documentation, forcing your team to scramble and consolidate fragmented data from multiple systems.
Finding the latest protocol version, approval details, or training completion becomes challenging, as they are scattered across multiple systems (IRB, IACUC, IBC) and buried in outdated emails and disjointed files
Every minute spent searching for files or reconstructing protocols is a minute lost from critical research. Each inefficiency represents a setback in advancing scientific discovery.
By continuously logging and tracking protocol data, eProtocol ensures that all necessary protocol documentation is always available and up to date. Every protocol update, approval, amendment, and modification is automatically recorded in a centralized, timestamped audit trail. This means your team is prepared for protocol audits without scrambling to gather last-minute information and the documentation is always complete, always current, and always accessible.
Everything. The system maintains a complete history of forms, comments, attachments, notes, agendas, meeting minutes, protocol submissions, amendments, modifications, incident reports, and notifications for each protocol. This creates a complete, transparent record from initial submission through final approval and all ongoing modifications.
Yes. eProtocol is designed to manage protocols across all compliance committees, including IACUC (animal research), IBC (biosafety), IRB (human subjects), RSC (radiation safety), CSC (chemical safety), SCRO (stem cell), and others. Our platform provides a centralized view of all protocol approvals and protocol status across all committees, with one unified audit trail, making it easy to generate comprehensive reports for any oversight body.
Instantly. With automated reporting features, you can generate comprehensive audit reports in seconds. Select the protocols, specify the date range, choose the report format, and the system generates complete documentation.
That's exactly what eProtocol is built to handle. Research institutions face audits from OHRP, FDA, USDA, NIH, AAALAC, AAHRPP, internal compliance offices, and study sponsors—often with overlapping requests. Because all your protocol data lives in one centralized system with one comprehensive audit trail, you can generate customized reports for each auditor from the same complete dataset, ensuring consistency across all audit responses.
By automating the tracking of protocol management activities and ensuring they're logged correctly, eProtocol dramatically reduces the staff time needed for audit preparation. Traditional systems require teams to manually pull protocol records, verify training certifications, validate protocol amendments, and compile consent forms for each audit request. With eProtocol, this information is continuously maintained and instantly accessible, transforming audit preparation from a multi-day scramble into a quick report generation task.
Yes. Our platform meets 21 CFR Part 11 requirements and runs in SOC 2-compliant data centers. Data is encrypted in transit and at rest, with role-based access controls and regular compliance audits.
Yes. The system is configurable to match your workflows, forms, and institutional requirements. We work with you during implementation to ensure the system reflects your specific processes and align with your institution's policies and standards.
See how eProtocol transforms protocol management from a compliance burden into a competitive advantage. Book a personalized demo and discover how continuous audit readiness can free your team to focus on advancing research.
