Within each Vault, they have steadily expanded the functionality available to Vault customers. For example, Vault Clinical began as an electronic Trial Master File (eTMF) solution, but now you can add a Clinical Trial Management System (CTMS), Study Startup, Payments and Site Connect in addition to Clinical Suite tools, such as Electronic Data Capture (EDC), Clinical Data Base (CDB) and Vault Coder. Each capability will require an additional investment, but economies can be gained considering life science companies need to manage many disparate technologies to do so.
Some companies will continue to opt for an approach that leverages a variety of technology providers, but there are many who embrace the suite approach to realize efficiencies anticipated by minimizing the vendors that comprise their IT portfolio. This approach has unique challenges and careful consideration should be given to avoid unanticipated consequences, which can lead to budget overruns.
When adding a technical capability to an existing platform, planning and business considerations potentially affect all users, not only the function to be supported by the new capability. Therefore, a holistic approach is required if this type of implementation is to succeed.
The webinar focuses on some careful technical and business considerations required when adding additional functional capability into an existing platform — Veeva Vault — including:
- Changes required to existing functionality (e.g., Expected Document List [EDL], Milestones and Document types)
- Data management (e.g., Master Data, Reference Data and Data Governance)
- Business Processes and standard operating procedure (SOP) documents that span functional groups
- Training across business functions
- Security Roles/Permissions
- System downtime/environment management
- System Governance
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