We will automate the creation of the Clinical Study Report (CSR).
Our company acts as the sales agent for the US-based company Symbiance's application software ZYLiQ in Japan, providing presentations, order taking, delivery, implementation support, and user support services in Japanese. We can also issue various documents such as invoices and delivery notes in the format specified by our customers.
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basic information
ZYLiQ is an application developed by the American company Symbiance. ZYLiQ utilizes artificial intelligence (AI) to automate the creation of Clinical Study Reports (CSR) and scientific documents related to clinical trials. A Clinical Study Report (CSR) is a lengthy document (typically 100 to 300 pages of main text and several hundred to thousands of pages of appendices) written by medical writers that describes the methods and results of a clinical trial. Typically, a significant amount of time is spent by medical writers manually drafting this document. Medical writers create the CSR by incorporating a substantial amount of information from source documents such as the Clinical Trial Protocol, Statistical Analysis Plan (SAP), Case Report Forms (CRF), and Serious Adverse Event (SAE) reports. ZYLiQ automatically extracts information from source documents like the Clinical Trial Protocol, SAP, and SAE reports, matching it to the appropriate sections according to the ICH E3 CSR guidelines. ZYLiQ reduces the considerable effort and time required by medical writers through automation. Additionally, ZYLiQ includes workflow and dashboard modules that can be configured according to the sponsor's needs.
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Applications/Examples of results
●This system is designed to generate CSR based on the ICH-E3 guidelines using information from protocols, SAP, and other sources, saving 60% to 70% of the medical writer's working time. ●Medical writers can focus on interpreting trial results and creating discussions. ●Workflow integration allows the system to be configured according to the sponsor's needs.
Company information
Our company collaborates closely with Japanese staff skilled in QC operations and medical and pharmaceutical experts who are native speakers of Japanese or English. Additionally, under confidentiality agreements, we have established a global network of translators and writers specializing in the medical and scientific fields, allowing us to appoint native experts from various countries who are best suited for each project. We hope you will continue to benefit from our coordination skills with translators and medical writers, as well as our highly proficient quality management system. Furthermore, we can mail printed materials about our company to customers who require them. Please feel free to contact us if you have any requests.
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