QLIFICA IRB

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QLIFICA

last updated：Oct 03, 2025

SOLUMINA

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Support for all operations related to clinical trial review.

This is a cloud service that supports a series of clinical trial review management tasks, from requesting reviews and holding meetings to notifying review results. IRB documents can be securely stored and shared in a safe environment, promoting a paperless approach. ■ Features and Benefits of QLIFICA IRB Point 1: Efficient creation support for standardized formats (Formats 3, 4, 5, Reference Format 1) Point 2: Collaborative use from the perspectives of IRB, medical institutions, and sponsors Point 3: Support from convening to holding IRB meetings Point 4: Notifications of review requests, results, and meeting announcements via email Point 5: Management of electronic originals compliant with ER/ES guidelines Point 6: Storage and viewing of documents in a high-security environment Please feel free to contact us for more details.

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■Cases for Consultation - Looking for an alternative system due to the abolition of Cut de Square (provided by the medical association) - Feeling limited by paper-based operations and wanting to achieve paperlessness through systematization - Finding the formats and procedures complicated, resulting in time and effort spent on communication with stakeholders ■Benefits of Implementation - Easily create standardized formats (Formats 3, 4, 5, Reference Format 1) - Complete the process from request for review to sharing meeting materials and notifying review results online - Centralize and streamline communication among stakeholders such as the secretariat, requesters, and committee members - Achieve paperless operations through electronic sharing of meeting materials and related documents - Automatically record operation history to clarify processes and responsibilities, supporting compliance with ER/ES guidelines for electronic original document management ■Main Features - Registration and management of committee and member lists - Registration of review items by requesters - Review requests by the clinical trial secretariat - Notification of review results by the IRB secretariat - Sharing, viewing, and history management of meeting materials for committee members - Storage of other related documents