Jan 15, 2025 · Contact Veeva Support to enable the Japanese CTN feature in your CTMS Vault. You can also contact Veeva Support to enable the Create CTN Data for Japanese Study Country feature, which allows Vault to automatically create CTN Data / 治験届関連情報 records for all existing Study Organizations , Study Persons , and Study Sites that have ...

Jan 15, 2025 · Vault provides the ability to fulfill J-GCP requirements by generating and managing Japanese CTN with other clinical trial activities through a set of functions. Note that your Admin must have configured Japanese Clinical Trial Notifications …

Jan 15, 2025 · Clinical Trial Notifications: Provides the ability to generate and submit Yuzu Clinical Trial Notifications (CTN) to the Japanese Health Authority (PDMA). Risk Based Study Management (RBSM) : Provides the ability for study teams to create, review, and approve study-specific risk assessments.

See how to enable faster, higher-quality trials.

Oct 31, 2022 · Yuzu: CTN Change Log Enhancements. This feature improves the automated tracking and support for CTN (Clinical Trial Notification) Data Change Logs used with the Yuzu capabilities for CTMS.

Mar 10, 2023 · Adopt CTMS Yuzu functionalities for the business running clinical trials in Japan and configured the ability to generate and submit Clinical Trial Notifications (CTN) to the Japanese Health Authority (PDMA).

We release a version of the RIA in advance of the general release. The Validation Impact Assessment, which contains validation information for new features that have validation impact in 22R3, will be available in the Veeva Compliance Docs (VeevaDocs) Vault on October 31st.

Retired separate Japanese platform and implemented Vault CTMS Yuzu functionality to submit compliant clinical trial notifications to Japanese regulatory authorities Here is a summary of lessons learned moving to modern CTMS.

Nov 27, 2020 · 臨床試験の効率とスピードの向上を求めるニーズが高まるなか、製薬企業トップ20社のうち6社を含む75社以上の企業が、 Veeva Vault CTMS を導入して臨床試験情報および臨床試験プロセスの統合化を実施しています。 また、Veeva Systems【NYSE:VEEV】 (本社 : カリフォルニア州プレザントン、日本法人 本社 : 東京都渋谷区、日本法人代表取締役 : 岡村 崇、以下 Veeva)の最新クラウドアプリケーションを採用して、試験の可視性を向上させて実施を迅速 …

Oct 19, 2021 · Yuzu: CTN PMDA XML Update. This feature allows Vault CTMS customers that have enabled the “Enable Japanese CTN Feature” to create CTN Documents corresponding to the latest guidance from Japan’s PDMA.