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The transparency guidelines revised in September 2018 by the Japan Pharmaceutical Manufacturers Association can be published in compliance with the Clinical Research Act. 【Features】 ■ Data compilation and upload can be completed by the company's responsible personnel. ■ Input one year’s worth of public information into an Excel template and upload it. ■ Has a search function that meets the search criteria specified in the transparency guidelines. ■ Public disclosure items can be adjusted for each company (minor adjustments are free of charge). ■ The format can be changed for each publication year. *For more details, please visit our company 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 of 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 a classification structure 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 a series of clinical trial review management tasks, from requesting reviews to holding meetings and notifying review results. IRB materials can be securely stored and shared in a safe environment, promoting a paperless approach.
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