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Press release
2019年10月30日 16時00分
Source:
Fujitsu Ltd
富士通、日本初、医薬品の申請電子データを自動作成する「tsClinical for SDTM Automation」を提供開始
申請電子データの利活用推進支援により日本の革新的な新薬創出に貢献
東京, 2019年10月30日 - (JCN Newswire) - 当社は、医薬品の申請電子データを標準規格のSDTM(Study Data Tabulation Model)形式に自動作成するソリューション「tsClinical for SDTM Automation」(ティーエスクリニカル フォー エスディーティーエム オートメーション)」(以下、「SDTM Automation」)を開発し、国内の製薬企業向けに10月30日より提供開始します。
本ソリューションは、製薬企業が医薬品の承認申請の際に規制当局へ提出する申請データを、臨床試験データのグローバルスタンダードを策定する団体であるClinical Data Interchange Standards Consortium(以下、CDISC)が掲げる標準規格のSDTM形式にシステム上で自動作成できるため、人手による作業ミスや標準規格の理解のばらつきを防ぎ、SDTM形式での申請電子データ(以下、SDTMデータ)作成業務のコスト削減、および品質強化を実現します。
国内の規制当局である独立行政法人医薬品医療機器総合機構(Pharmaceuticals and Medical Devices Agency、以下、PMDA)(注1)は、2020年4月からSDTM形式での電子申請を義務化します。当社は、本ソリューションを提供することで、SDTMデータの自動作成(特許出願済)を世界に先駆けていち早く対応します。これにより、製薬企業各社が抱えるSDTMデータの品質担保や作成リソースの確保、作成コストの抑制などの課題を迅速に解決するとともに、PMDAによる臨床データの活用推進を支援し、日本の革新的な新薬創出に貢献します。
本リリースの詳細は下記をご参照ください。
https://pr.fujitsu.com/jp/news/2019/10/30.html
概要:富士通株式会社
詳細は
http://jp.fujitsu.com/
をご覧ください。
Source: Fujitsu Ltd
セクター: エレクトロニクス, IT
Copyright ©2024 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.
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