Program一覧

Learn about Veeva's digital clinical trials strategy and the latest innovations of Veeva Development Cloud

1.The speaker will share his thoughts on key factors to be successful in Digital Transformation (DX) for patients leveraging values of cloud services such as Veeva.

2.Collaboration and partnership with Veeva (R&D) in Astellas R&D business toward the realization of the vision of "On the forefront of healthcare change to turn innovative science into VALUE for patients".

Veeva's "SiteVault" was installed to solve the challenges facing the clinical trial industry and the dilemma of COVID-19.
We were looking for a way to complete clinical trials remotely without the need for on-site monitoring and looking for a way to use R-SDV. We tied up with Veeva, a global leader in R-SDV and the clinical trial industry, to continue our quest to solve the problems of the clinical trial industry.
In the session, we will talk about the issues leading up to the "Site Vault" installation, the evaluations from the sponsors, and future efforts to expand the use of "Site Vault".
"Remote" is not only essential for the clinical trial industry now, but also in the future. Now that we have taken the first step toward using SiteVault as the source for all data from medical institutions, let's move forward from the Japanese standard to the global standard.

Computerization and ERES in Japanese manufacturing "GEMBA" are drastically progressed, but still Paperless is not achieved in many of GEMBA. There are various types of Plan/Report and Instruction/Record in "GEMBA", but some of them are not easy to be computerized. I'd like to share a progress of our challenge to computerize them and its issues.

Roche’s regulatory transformation lead will share how his team is spearheading efforts to bring different regulatory functions together under a common set of modern business capabilities. Learn more about their OneRegulatory strategies and roadmap to meet both present and future patient needs.

Presenting an overview of SiteVault Free, a key part of the groundbreaking Digital Trials Platform which has received a lot of attention since release in 2020 January. We will provide an overview of the product, introduce some of the new enhancements coming in 2021 and talk about our approach to the Asian market.

New features of Vault Training evaluation training management will be introduced with demonstrations.

Veeva's vision for RIM

Bayer shares the value of digitally connected clinical trials. Hear about best practices to implement technology, drive change, and improve collaboration with sites.

Kyowa Kirin’s overriding goal has been to transform into a Japan-based Global Specialty Pharmaceutical Company. The Vault Quality Suite is being deployed globally across the regions under the One Kyowa Kirin Quality initiative. Here we share our experience and vision toward the transition into the One Global QMS.

EliLilly started to explore the Veeva EDC and Clinical Operation capabilities in2018 as one of the clinical system transformations in Clinical Data management,Trial management and Clinical Operation globally. Lilly Japan is proactivelycollaborating from 2019 in EDC early adopter studies and gain learnings toprovide feedback to enhance our system and associatedprocess. Also, we are adopting to Clinical Operation capabilities in align withglobal platform transformation strategy with our country regulatory andoperational requirements. It’s great opportunity to consolidate our clinicalsystems and gain efficiency with automation. We are going to share our currentadoption status in Clinical data and operation platform with our learnings andkey success factor to gain business value in technology transformation towards our future state.

Introducing the overview, the latest functions and the current roadmap of Clinical Suite.

Hear Veeva’s vision and roadmap for Vault Quality Suite. See how upcoming features like Audit Management, Quality Recurrence Check, and On-the-Job Training will enable proactive quality management and increase compliance.

Learn what is about Vault CDMS and key features, how Vault CDMS will change, and why, over the next 12 months, from meeting customer requests, to expanding Vault Connections, and launching Veeva CDB.

1.BIKEN take the Essentials Approach to implemente Vault eTMF and QualityDocs. I'll introduce the process.

2.Introduction and case study of a quick and efficient implementation program with Vault Essentials Implementation Package

Global IT systems for managing QMS activities are widely adopted in manufacturing including GMP.
However, there are challenges in introducing these systems into Clinical QMS, and it is important to meets some requirements in GCP area.
In this session, I would like to compare the system requirements both GCP and GMP, and introduce our case studies.

ClinChoice participates in the Veeva CRO Partner Program for Clinical Data Management. In this session, we will cover Vault EDC build/operation experience collaborating with Veeva in a Global Clinical Research.