Clinical Data Applications Overview

Veeva’s Clinical Data Platform provides a unified, end-to-end solution for the collection and management of clinical trial data. Its robust connectivity facilitates regulatory compliance, streamlines trial administration, and enables faster identification of the data that drive critical decisions. With a seamlessly integrated product suite, systems communicate freely to prevent silos and improve efficiency, helping to reduce the time to market for new medications.

Veeva EDC

Veeva EDC is a modern, flexible electronic data capture system that is designed to reduce the manual and administrative burden for sites and sponsors. Veeva EDC’s modules centralize the collection and standardization of disparate types of clinical trial data. With its intuitive, role-based user interface, Veeva EDC enables efficient study design, streamlined data entry, and simplified review and monitoring processes. Localization support allows sponsors to tailor the languages of studies and UI as needed.

EDC Functions & Modules

Study Design

Veeva EDC supports the efficient and agile design of studies of any complexity through Studio, the study design module. This powerful and intuitive interface makes it possible to build study designs using an intuitive drag-and-drop interface to easily create study objects and case report forms (CRFs). Study designers can also easily reuse forms from Library collections or previous studies. Edit Checks, User Defined Rules, and Comparison Rules can be implemented with no custom programming needed, greatly reducing study build times and making it possible for study designers without software programming expertise to create a complete study. When a study needs to be amended after it is in production, Veeva EDC can support post go-live amendments, with no migrations needed.

Data Entry

Veeva EDC’s Data Entry UI is clean, structured, and easy for site staff to use. Its simplified navigation makes it easy to find and respond to queries. The intuitive layout and logical Casebook structure make navigating between Subjects and Forms easy, reducing data entry time. Real-time edit checks and data validation notify users of missing or inconsistent data, reducing transcription errors and improving efficiency. Comprehensive audit trails track data entry and changes ensuring regulatory compliance.

Monitoring & Review

Veeva EDC simplifies clinical trial monitoring and review to help ensure the integrity of clinical trial data. Customizable Review Plans allow configuration of the Study to only require SDV or DMR on the Items that need it, saving monitoring and data management users’ time. Veeva EDC offers a number of standard reports and dashboards that provide visibility into key study metrics from the Reports tab.

Veeva EDC Modules

Veeva EDC offers a number of modules and features that empower risk-based data review, driving faster decisions and more effective trials.

Local Labs: provides easy access to centralized lab locations, normal ranges, and an Analyte Library, seamlessly integrated into Veeva EDC.
Veeva EDC Imaging: allows Imaging data gathered in the course of your Study to be shared across all CDMS modules.
Data Loader: eliminates manual data entry for large scale test results, instead importing data and automatically entering it into configured Forms and their data collection Items.
Study Grade: reviews and grades studies based on the study’s adherence to best practices.
Veeva Coder: a tool for the medical coding of terminology used in clinical trials that transfers casebook data and coding queries in real time, with no reconciliation necessary.
Medical Assessments: supports the supplemental assessment and review of relevant casebook data to support decision-making about trial data.
Clinical Reporting: Clinical Reporting provides basic reporting access to EDC clinical data captured in the Vault EDC application.
Visit Method: allows you to specify what type of visit the event can be categorized by: On Site Visit, Virtual Visit, At Home Visit, Alternative Facility Visit, or Telephone Interview.
Veeva EDC API : enables secure integration with external systems, built on Vault Platforms API.

Veeva DQS

The growing complexity of modern clinical trials requires study teams to aggregate data from many sources. Veeva DQS (Data Quality System) ingests and transforms clinical data from multiple sources, including non-EDC data. It offers a suite of features that enhance the quality of trial data by ensuring that it is timely, complete, accurate, and reliable.

Data managers and medical reviewers can use DQS to access and clean the latest trial data, assess its status, and track review progress. They can log data issues on any source by using manual queries or automated checks, to communicate with data providers without switching between EDC, trackers, and emails. Metrics support the implementation of risk-based data management for your study, by tracking KRIs and QTLs that help you to monitor and mitigate risks that might impact patient safety, data integrity, or study outcomes.

Built specifically for clinical trials, Veeva Clinical Query Language (CQL) is a powerful tool for programmers to retrieve and transform data for DQS reviewers and downstream systems.

Veeva DQS Components

Study Connector

Study Connector aligns diverse data sources to a common study backbone, making it easier to compare and reconcile data from different sources. DQS supports data ingestion and mapping from all systems including EDC, eCOA, Labs, and RTSM, and including both Veeva and non-Veeva systems. Data managers can seamlessly work with data from different sources in DQS Workbench.

DQS Workbench

Workbench is the central workspace for data management and medical review teams to clean and review clinical trial data. It streamlines the review process and supports discrepancy identification, allowing teams to use observations for internal cross-team collaboration before querying research sites and/or data providers. Checks support the automation of the query and protocol deviation identification process for more efficient cleaning of the most repeatable discrepancies. Metrics drive the early detection of systemic data quality risks through configurable Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs).

You can use CQL, DQS Workbench’s clinical query language, to easily query data. With a built-in awareness of clinical data patterns and relationships, CQL simplifies the process of querying clinical trial data by using a streamlined, clinical-focused syntax.

Study File Format API

The Study File Format (SFF) API can integrate with downstream systems to deliver either full study data or partial (incremental) study data for specific purposes. This standardized method of exporting clinical data from Veeva EDC and DQS systems facilitates reporting on clinical and operational data and integration with other systems.

Veeva DQS Modules

Veeva DQS offers a number of modules and features that .

Automated Checks: Veeva DQS offers checks, which automate the cleaning process for the most repeatable discrepancies. Checks are automatically run on new and incoming data when it is loaded into the system from internal or third-party sources. If a discrepancy is found, the system creates a query automatically, reducing manual review effort. Query resolutions can also be automatically recognized and closed. Automated checks can also be used to identify protocol deviations based on pre-defined logic, reducing manual effort. The intuitive, spreadsheet-like Workbench interface lets users access all study data from a central location. Listing, query, and protocol deviation information is viewable directly from the Data Workbench, eliminating the need to log in to EDC or refer to an external tracking sheet.
Observations: Observations allow data managers to collaborate with colleagues to review and discuss discrepancies before generating queries. You can create observations on Form Items, single-function Form Items, and Event Dates using EDC or third party data.
Metrics: Metrics support the risk-based data management of your study through tracking Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) that enable you to identify departures from acceptable risk ranges. In a clinical study, metrics enable you to monitor and mitigate risks that might impact patient safety, data integrity, or study outcomes. In Workbench, you can easily create metrics to define, visualize, and monitor KRIs and QTLs at the study, site, country, or subject level, accelerating identification and resolution of potential issues.
Clean Patient Tracker: With the Clean Patient Tracker, data managers can track the cleanliness of subject data and take direct action on review and cleaning activities. This built-in report summarizes all data collected for each subject, offering drill-down to patient and query data. The tracker replaces manual spreadsheet reconciliation with an automated dashboard, empowering teams to confidently monitor and drive patient data cleanliness in real time.
Listing Builder: Veeva Listing Builder is a drag-and-drop tool that data managers use to build Listings, Checks, or Views without writing CQL syntax. This intuitive interface helps users build and modify listings quickly while pulling data from multiple forms, visits, and data sources. Listing Builder automatically generates CQL code based on the selections made in the interface, lowering the barrier to entry and transforming clinical trial data into meaningful information.
CQL: Veeva CQL is a Veeva-built clinical query language that reduces the effort and technical expertise needed for data cleaning and transformation. Clinical programmers can calculate derived values and build sophisticated listings with minimal effort. This feature offers comprehensive pre-built functions, performing tasks that normally take hundreds of lines of code in just a few.

Veeva eCOA

Veeva eCOA (electronic Clinical Outcome Assessments) captures questionnaire responses directly from clinical trial patients (ePRO), clinicians (eClinRO), or patient caregivers (eObsRO) using an app or webpage.

Sponsors can manage the eCOAs through a dedicated interface. A central library allows them to retain and reuse eCOAs across all their studies. Veeva also offers localization support for surveys targeting users who speak various languages.

Sites can manage their participants and can review eCOA data and adherence via an easy-to-use access point.

Patients and caregivers complete the questionnaires using MyVeeva for Patients (native application or web), where they can also access other activities like consent or virtual visits. Once complete, the data automatically flows back into the sponsor’s environment.

Veeva eCOA is a unified system that seamlessly connects sponsors, sites, and patients across the entire eCOA process. Data collected from Veeva eCOA can flow into Veeva DQS to provide deeper insights.

Veeva eCOA Features

Interactive Design Process, Accelerated Study Build

Stakeholders can be engaged early in the design process and throughout the study build process with eCOA previews across all device types and available languages. eCOA accelerates study design by supporting a library of reusable and validated instruments, sourced from both Veeva and sponsor libraries, as well as auto-generated screenshot documents for site review and IRB/ethics packs.

Self-Service Management Tools, Version Control

Sponsors can track study progress, make rapid mid-study changes, and export data on-demand, without extra cost or delay. Veeva eCOA offers complete tracking and audit trails for instruments, translations, and amendments to support compliance at every step of the study.

Veeva eCOA notifies patients of ePROs requiring completion and alerts sites if they are not completed or missed. Within the site UI, indicators clearly guide the sites through outstanding activities that need to be completed during patient visits.

Veeva eCOA makes access simple and secure. Users can login with a username and password, PIN, or choose to activate biometric authentication (fingerprints and facial recognition). Patients can access eCOA using their own device, including Android, iOS, or via a web browser.

Veeva EDC & DQS Connections

Veeva EDC, DQS, and eCOA are part of the broader Veeva Clinical Platform, and offer productized connections to create powerful unified architecture that allows for data to flow across Clinical Operations vaults, Clinical Data vaults, and Safety vaults.

Veeva Clinical applications are built on the shared Vault Platform, enabling seamless connectivity across clinical data and operations. This shared infrastructure reduces manual reconciliation and provides end-to-end visibility so that teams can spend less time entering data and more time extracting the actionable insights that advance the life sciences industry.

Safety-EDC Connection

Veeva Safety is an individual case safety report (ICSR) management system that manages intake, processing, and submission of adverse events for clinical and post-marketed products, streamlining adverse event management. Veeva Safety integrates with EDC via Safety Link to automate the transmission of safety related case data. This connection ensures accurate, timely SAE reporting while reducing site burden and manual transcription errors.

Through the Safety-EDC Connection, synchronization of data between Veeva EDC and Veeva Safety is managed and maintained with mapped data fields. Organizations can easily add, modify, or disable default fields, simplifying setup and configuration.

Clinical Operations-EDC Connection

Veeva CTMS , part of the Clinical Operations platform, provides end-to-end study management and monitoring capabilities for insourced and outsourced trials. The Veeva CTMS connection with Veeva EDC supports monitoring and payments (via Veeva Payments ), and offers real-time visibility into study statistics such as enrollment status. Site staff can navigate directly to casebooks in EDC from within Veeva CTMS, without logging in separately.

The Clinical Operations-EDC Connection enables the seamless flow of information by automatically exchanging new records and updates to existing records in a fast, streamlined way through the Veeva Vault platform. Field mappings bridge the terminology differences between EDC and CTMS such as subject events and subject visits.

Veeva RTSM

Veeva RTSM is a reliable and user-friendly randomization and trial supply management solution designed to simplify complex processes and expedite clinical trials. Through the secure, consistent, repeatable connection with Veeva EDC, data entered in the Veeva RTSM system is sent to Veeva EDC in real time via a REST API, and automatically creates Subjects and Events in EDC, reducing the need for duplicate data entry by site staff and increasing efficiency.