SOLUMINA List of Products and Services

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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QLIFICA eDocs is a cloud service that handles document information online, enabling the aggregation, organization, workflow management, and storage of document information. It offers more minimal features than QLIFICA eTMF, allowing for easy document management. ■ Features and Benefits of QLIFICA eDocs Point 1: Store document files in a high-security environment Point 2: File management through folder structure Point 3: Manage workflows such as reviews and approvals Point 4: Securely share documents with team members and relevant parties Point 5: Manage electronic originals in compliance with ER/ES guidelines Point 6: Clarify the history of changes and accountability from records For more details, please feel free to contact us.

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This is a cloud service that handles document information related to clinical trials and clinical research online. It builds a classification structure for each trial, enabling the aggregation, organization, workflow management, and storage of document information. It can be used by companies such as pharmaceutical and medical device manufacturers, CROs, and medical institutions like hospitals and clinics. ■ Features and Benefits of QLIFICA eTMF Point 1: Document files are stored in a high-security environment. Point 2: Management is possible with classification structures such as the TMF Reference Model. Point 3: Workflow management for reviews, approvals, etc. Point 4: Secure sharing of documents with team members and relevant parties. Point 5: Electronic original document management compliant with ER/ES guidelines. Point 6: Clarification of the history of changes and accountability. Please feel free to contact us for more details.

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This is a cloud-based system that supports the monitoring of clinical trials and clinical research in quality management and quality assurance according to GCP and clinical research laws. It streamlines monitoring and assists in compliance with plans. It can be used by pharmaceutical and medical device manufacturers, CROs, and medical institutions such as hospitals and clinics. ■ Features and Benefits of QLIFICA Monitoring Point 1: Centralized management and team sharing of monitoring implementation status Point 2: Monitoring implementation and performance registration using checklists Point 3: Easy creation of monitoring reports and smooth reviews Point 4: Clarification of history and responsibility through output of monitoring history Point 5: Centralized management of trial implementation status and output of tracking files Point 6: Multifaceted guidance to assist users with limited work experience Please feel free to contact us for more details.

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The transparency guidelines revised in September 2018 by the Japan Pharmaceutical Manufacturers Association can be published in a format compliant with the Clinical Research Act. 【Features】 ■ Data compilation and upload can be completed by company representatives ■ Enter one year’s worth of public information into an Excel template and upload it ■ Possesses a search function that meets the search criteria outlined in the transparency guidelines ■ Public disclosure items can be adjusted for each company (minor adjustments are free of charge) ■ Format can be changed for each publication year *For more details, please visit our website.

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■QLIFICA Monitoring A cloud-based system that supports the monitoring of clinical trials and clinical research in quality management and quality assurance according to GCP and clinical research laws. It streamlines monitoring and supports compliance with plans. ■QLIFICA eTMF/eDocs A cloud service that handles document information related to clinical trials and clinical research online. It builds classification structures for each trial, enabling the aggregation, organization, workflow management, and storage of document information. eDocs offers minimal functionality compared to eTMF, allowing for easy document management. ■QLIFICA IRB A cloud service that supports the entire process of clinical trial review management, from requesting reviews to holding meetings and notifying review results. IRB documents can be securely stored and shared in a safe environment, promoting a paperless approach.

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