Veeva Vault CDMS

The ability to manage all trial data, including non-CRF, dramatically improves visibility during a trial. With a complete and concurrent view of their data, clinical development teams can make better decisions faster.

* Vault Data Workbench is planned for availability in late 2019.

BENEFITS
  • Complete and current data: Gain transparency and visibility to all clinical data for both local and remote (CRO) trials.
  • Accelerate study cycle times: Deploy studies in days, not weeks and improve time to database lock with a flexible, formless view of your data that is better for cleaning and monitoring.
  • Simple and cost efficient: Replace multiple applications with one solution, reducing the burden of data integrations for clinical trials.
  • Connected clinical: Connected to Veeva’s unified clinical operations suite that includes Vault CTMS, Vault eTMF, and Vault Study Startup.

Streamline source data verification and review

Real-time edit checks in electronic case report form

Simplified navigation across study hierarchy

Veeva Vault EDC

Vault EDC is part of Veeva Vault CDMS. It provides a fast and intuitive interface for capturing clinical trial data. Designed for flexibility, Vault EDC allows you to run complex multi-arm adaptive trials and make mid-study amendments without downtime or migrations. Veeva is delivering a better EDC that lets you run the trial you want.

AGILE DESIGN STUDIO
Vault EDC provides a configurable collaboration environment with built-in review and approval workflows. Users can build casebooks with easy drag-and-drop functionality.
DATA-DRIVEN PERSONALIZATION
Personalized user dashboards and workflows provide immediate direction of users’ tasks and minimize time spent searching for information. The role-based user interface optimizes the order and structure of data differently for data entry, data cleaning, and monitoring to provide the ideal view for each activity.
RETROSPECTIVE CASEBOOK AMENDMENTS
Vault provides an elegant migration-less approach to EDC design changes for in-flight studies. When new requirements are added, any completed forms are reverted to an incomplete state and the new fields are flagged for site personnel to populate.


BEST IN CLASS PLATFORM
A scalable platform that has the flexibility to amend designs at any stage without downtime or migrations. A scalable cloud platform that is easily accessed by sponsors and CROs, providing both parties with direct access to the data. And as a true multitenant platform, Vault delivers a rapid pace of innovation with three releases per year.
MODERN USER EXPERIENCE
A modern user experience greatly increases usability, adoption, and performance. During data entry on a form, real-time edit checks increase accuracy, entry performance, and user satisfaction. The quick-jump navigation reduces time spent navigating between subject casebooks, events, and forms.
SEAMLESS CONNECTION TO CTMS
Easily leverage operational data from Vault EDC for reporting within Vault CTMS. CTMS users can report on the status of subjects and dates captured in Vault EDC, as well as navigate to a subject’s casebook in Vault EDC.



Veeva Vault Coder

Map highly variable free text entries or “verbatims” to standard coded terms based on MedDRA or WHODrug dictionaries. Vault Coder, a part of Veeva Vault CDMS, lets you code clinical form verbatims for data on trial medications, adverse events, prior surgeries, medical histories, and more.

MINIMIZE MANUAL CODING
Batch coding, auto-coding, and auto-generated suggestions minimize manual coding effort. Capabilities include: coding suggestions based on previously coded items; bulk coding multiple verbatims simultaneously; and background coding jobs to auto-assign codes based on customizable synonym lists.
INTERCONNECTED WITH EDC
Code requests are generated automatically at form submission and code values are stored directly within Vault EDC’s database. When a form change in EDC affects a coded property, Vault Coder clears the assigned code and changes the request status to “updated.” There is no extra effort, delay, or integration cost.


STANDARD DICTIONARY SUPPORTED
Support is provided for the industry-standard World Health Organization Drug Dictionaries (WHODrug B3 and C3) and the Medical Dictionary for Regulatory Affairs (MedDRA 20.0+).


INITIATE QUERIES
Send and receive messages to a site directly from within Vault Coder. See a complete discussion thread regarding each coding query.