GCP適合性調査/TMFリファイリング支援

GCP適合性調査/TMFリファイリング支援

GCP適合性調査/TMFリファイリング支援

社内資料管理体制の構築や他社実施試験資料の整理、適合性調査対応のための試験資料の整備など、TMF関連業務のご提案について、ご紹介しています。

 

主なサービス内容

【GCP査察準備】
  • ● 紙TMF(治験関連文書)(Paper TMF)の電子化対応
  • ● ライセンスイン・ライセンスアウトなどに伴う実施済み試験のTMF確認やリファイリング
  • ● eTMFなどのシステム導入サポート
  • ● 承認申請(NDA)・適合性調査準備サポート
【品質マネジメント体制(QMS:Quality Management System)を見据えた文書管理体制構築】
  • ● 治験文書の電子化、DX対応プロセス検討
  • ● 文書管理SOPなど資料管理プロセスの構築
(例)
 
・Filing Index構築
 
・CDISC TMF Reference Model準拠などに関する相談
 
・Timeliness/Quality/CompletenessのKPI、メトリクス管理 など
 
 

受託サービスの詳細は、説明資料(ダウンロード)をご覧ください。

 

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