Demystifying CDISC, SDTM, and ADaM Blog CDISC、SDTM、およびADaMについてわかりやすく解説 Breaking down the basics of CDISC’s CDASH, SDTM and ADaM standards, to help you understand…Certara2024年5月22日
Leveling Up SDTM Validation with the Magic of Data Managers Blog Leveling Up SDTM Validation with the Magic of Data Managers In this abstract, Julie Ann Hood and Jennifer Manzi look at how you can improve…Certara2024年5月19日
Dreaming big with standardization in clinical trial design – one biopharma’s metadata automation journey Case Study 臨床試験デザインの標準化で大きな夢を描く - あるバイオ製薬会社のメタデータ自動化への道のり This case study explores how one biopharma gets deeper insights & more informed decision making…Certara2024年5月13日
How one university overcame practical and cultural challenges to implement CDISC compliance Case Study How one university overcame practical and cultural challenges to implement CDISC compliance A US-based university with a nationally recognized academic health center implemented Clinical Data Interchange Standards…Certara2024年5月8日
A Best Practice Guide to CDISC SDTM Mapping Guide A Best Practice Guide to CDISC SDTM Mapping Certara2024年5月7日
How Chinese CRO, Zhejiang Longcharm Biomedical Technology Uses Pinnacle 21 Enterprise to Optimize Sponsors’ Non-clinical and Clinical Regulatory Affairs Case Study 中国のCRO、Zhejiang Longcharm Biomedical Technology の Pinnacle21 Enterprise 活用方法:スポンサーの非臨床および臨床薬事業務を最適化 Learn how one CRO uses Pinnacle 21 to optimize sponsors’ clinical regulatory affairs, saving time…Certara2024年5月6日
Why are Clinical Data Standards Essential for EDC and Non-EDC Data? ブログ Why are Clinical Data Standards Essential for EDC and Non-EDC Data? Clinical data standards are essential for both EDC & non-EDC data. Learn how study build…Certara2024年4月25日
Pinnacle 21 Releases New PMDA, FDA, NMPA Validation Engines Announcement Pinnacle 21 Releases New PMDA, FDA, NMPA Validation Engines Pinnacle 21 by Certara announces the latest Validation Engines for submissions to Japan PMDA, US…Certara2024年4月23日
CRF Design Checklist Guide CRF Design Checklist Our free, downloadable CRF design checklist can help you design quality case report forms that…Certara2024年4月10日
臨床メタデータリポジトリに期待すべき役割とは? ブログ 臨床メタデータリポジトリに期待すべき役割とは? 2024年4月4日 As the clinical research industry moves towards more efficient and automated processes, clinical…Certara2024年4月4日