Veeva CDB

Gain a complete and concurrent view of all the data in your study.

Seamlessly integrate all types of clinical trial data, including labs, ePRO and randomization data. Veeva CDB will assemble all the data for a study into a consistently formatted data lake for integrated cleaning, reporting, and export. Data automatically syncs through Vault EDC, Vault Coder, and a variety of external data sources with open APIs. Sponsors gain complete visibility into data from their trial, whether managed internally or by CROs.

Veeva CDB is planned for availability in 2020.

Features

Automated Ingestion Engine

Aggregate and harmonize your data from Vault EDC and external data sources. The ingestion engine loads data on-demand or on schedule, associates it with the correct study and subject, and detects any changes to the data or data structure. Productized integrations and open APIs will increase reliability while lowering the cost and complexity of system integrations.

Clinical Database

Diverse data sources are aligned to a common study backbone, making it easier to compare and reconcile data from different sources. Gain instant access to all metadata associated with each data point. Data is then accessible through CQL, an intuitive and efficient data querying language specific to clinical data.

Clinical Query Language (CQL)

A new programming language, designed specifically for clinical trials. Pre-built functions exist for common tasks and edit checks, replacing hundreds of lines of SQL with a few lines of CQL. Clinical programmers can perform advanced functions on their data, calculate derived values, and build sophisticated queries with minimal effort. Data managers gain new-found powers and get closer to their data than ever before.

Clinical Listings

Study data reports, or core listings, are generated automatically for each data source – no configuration needed. Users work with a powerful, Excel-like interface for viewing and filtering data along with purpose-built tools for cleaning, reconciling, and transforming data. Centralize discrepancy management with listings that compare sources and highlight exceptions and the ability to manage queries for all data types.

SDTM Exports

Easily consolidate and transform data into SDTM for the FDA, or to the preferred format for your statisticians, medical monitors, and other stakeholders. CDB will auto-suggest SDTM transformations based on your EDC study design and allow users to make further modifications with purpose-built tools for transforming data. Reusable export definitions for your clinical and operation data saves you the weeks of time and costly programming previously required.

Operational Reporting

Operational reports provide valuable insights as data is being collected and consolidated. Track the status of data from every source at every step in the process, from data entry, data cleaning, SDV, review, and locking. Get reports in real-time and drill down from high-level dashboards to granular reports. Sponsors and CROs each gain real-time visibility into the data without sending frequent requests and reports back and forth.