Medidata Rave vs Veeva Vault EDC

11 min readJan 17, 2023

Most commonly used edc systems are Medidata Rave, Inform, Medrio EDC, REDCap, and Veeva Vault EDC.

I will provide comprehensive difference between Medidata Rave vs Veeva Vault EDC.

Veeva Vault EDC

Veeva Vault EDC is a powerful, cloud-based electronic data capture (EDC) solution that enables life sciences companies to streamline and automate the collection, validation, and reporting of clinical trial data. It is built on a modern, secure, and flexible platform that supports all types of trials, including global, multi-regional, and specialized studies. The solution enables users to create, manage and monitor all aspects of a study, from study design, to data collection, to reporting. Additionally, it also provides a range of eSource capabilities, mobile data collection, and real-time data monitoring.

Some of the key features of Veeva Vault EDC include:

Real-time data validation and data quality checks
Data reporting and analysis
Advanced security and compliance features to protect patient data
Support for both traditional and decentralized clinical trials
Ability to integrate with other Veeva products, such as Veeva Vault eTMF for document management
User-friendly interface, which makes it easy for trial staff to use and reduces the training time required

Veeva Vault EDC is widely used in the life sciences industry and is considered to be a leading EDC system in the market. It is designed to meet the specific needs of the life sciences industry, and has been widely adopted by pharmaceutical, biotech, and medical device companies.

Veeva Vault EDC is designed to help streamline the data collection process, making it easier and faster for trial staff to enter and validate data. This can help to reduce errors and inconsistencies in the data, and improve the overall quality of the trial data. It is also designed to be easy to use, with a user-friendly interface that can be customized to meet the specific needs of the trial.

One of the key benefits of Veeva Vault EDC is that it is built on the Veeva Vault platform, which is a secure, cloud-based content management system. This allows for easy scalability and accessibility, and enables trial staff to access and manage the data from any location. Additionally, it allows for integration with other Veeva products, such as Veeva Vault eTMF for document management, which can help to improve the efficiency of the trial and reduce the time required to manage and maintain trial-related documents.

Veeva Vault EDC also offers advanced security and compliance features that help to protect patient data. It is designed to meet the requirements of the FDA 21 CFR Part 11 and EU Annex 11 regulations, and includes features such as data encryption, secure data storage, and an audit trail to track changes to the data.

In summary, Veeva Vault EDC is a leading EDC system in the market, specifically designed for the life sciences industry, it offers a comprehensive data management solution that includes real-time data validation, data reporting and analysis, and advanced security and compliance features. It’s built on the Veeva Vault platform, which allows for easy scalability and accessibility, and enables trial staff to access and manage the data from any location. it can be integrated with other Veeva products to improve the efficiency of the trial and reduce the time required to manage

Components of Veeva Vault EDC

Veeva Vault EDC is composed of several key components that are designed to streamline and automate the clinical trial process. These include:

Study Design: Allows users to create and manage the structure of a study, including the data entry forms, rules and validation checks, and workflows.
Data Collection: Allows users to enter and validate data, as well as perform real-time data monitoring and quality checks.
eSource: Enables the capture of data directly from the source, such as electronic health records (EHRs) or other systems, reducing the need for manual data entry.
Mobile Data Collection: Allows for data collection via a mobile app, which enables users to enter data from anywhere and at any time.
Reporting and Analytics: Provides robust reporting and analytics capabilities that allow organizations to gain insights into their clinical trial data and make data-driven decisions.
Compliance and Security: Built to be compliant with industry standards such as 21 CFR Part 11, GCP, and ICH guidelines, and is regularly updated to keep up with the latest regulations.
Integration: Seamless integration with other Veeva Vault products as well as third-party systems, such as electronic health records (EHRs) and clinical trial management systems (CTMSs) which allows organizations to streamline their clinical trial operations and eliminate data silos.
User Management: Allows for easy user management, including role-based access control, which helps to ensure that only authorized users can access sensitive data.
Data Management: Allows for the management of all aspects of the study, including data entry, validation, and reporting. Additionally, it also provides tools for managing study metadata, such as protocols, protocols amendments, and CRF’s.
Data Quality: Provides real-time data monitoring and quality checks to ensure that data is accurate and complete. It also provides tools for identifying, tracking, and resolving data issues.
Study Management: Allows for the management of all aspects of the study, including study progress, timelines, and budgets.
Collaboration: Provides tools for collaboration with external partners, such as CROs, sites, and regulatory authorities, which helps to streamline the study process.
Audit Trail: Provides an audit trail of all data changes and user actions, which helps to ensure compliance with regulations and audit requirements.
Mobile App: Access and entry data from anywhere and at any time with the available mobile app.

Overall, Veeva Vault EDC is a comprehensive solution that provides a wide range of features and capabilities that are designed to streamline and automate the clinical trial process. It is built to be compliant with industry regulations and its integration, data quality, and reporting capabilities make it a valuable tool for organizations in the life sciences industry.

Main Internal Components of Veeva Vault EDC:

1. Study Management : From EDC Tools > EDC Tools > Study Master’s Name in the Study Listing > create an environment
2. Site Management :
Assigning Review Plans to Sites / Creating Sites: From EDC Tools > open the Sites tab > Click + New Site
Assigning Review Plans to Sites : Tools > EDC Tools > Review Plan Assignment
Managing Study Countries: EDC Tools > Study Countries

3. Subject Management: Transferring Subjects: EDC Tools > Casebook Versions > Active Versions by Site > TSite Number >ransfer Subject
4. Medical Assessments : Assessments Administration ; Tools > EDC Tools > Assessments

5. Data Management:
Locking Studies & Sites: Tools > EDC Tools > Deployments > Environment > Actions > Lock
Closing Out Sites: EDC Tools > Sites > Site > Actions > Generate Closeout PDFs

6. Connections :
Connecting to an FTP Server from EDC Tools : Tools > EDC Tools > FTPS
Managing External Connections : Tools > System Tools > External Connections > Click + New Connection

7. Jobs:
Job Management: EDC Tools > Job History/Jobs Schedule > Click + New Job
Adding a Job
Editing a Scheduled Job
Deleting a Job
Canceling a Running Job
Refreshing the Job History
Job Types for Study Administrators
Scheduling Flash Reports
Study Data Extracts: The Study Data Extract job allows data managers to extract and download study execution data from EDC Tools.
Study Data Extracts Versioning
8. E2BLink
9. Integration Configuration
10. Randomization
A. Randomization Settings:
Randomization Types: Simple Randomization, Blocks, Stratification, Stratification with Blocks, and Mixed Blocks
Dynamic Site Assignment
B. Enrollment:
Export an Enrollment List : Randomization > Enrollment > Actions select Download CSV
Randomization Status contains three Randomization Statuses: Ready for Randomization, Randomized, and Invalidated
C. Randomization Lists: Randomization > Randomization Lists
D. Unmasked Data: This tab provides a listing of all unmasked data and is only accessible via an explicit permission. The following data can be masked in the Randomization tab.
Sequence
Rand ID
Subject
Subject Status
Site
Rand Status
Block Number
Treatment Name
Kit/Device ID
Strata Group
File Label
E. Stratification: Randomization > Stratification > Generate Strata Groups
Kits/Devices: Randomization > Randomization Settings > Click Edit at the top right of the page > Choose the correct options from the dropdown menus next to Use Kit ID and Use Device ID in the Related Data subsection > Click Save

Question:
How to create a manual protocol deviation in Vault CDMS?
Answer:
Monitoring users can manually create Protocol Deviations from the Review tab if the study has enabled this feature.
Navigate to Review tab > Study > Site.
Choose from the Subject, Event, Form or Item level.
From the More Actions menu, select Create Protocol Deviation.
In the Create Protocol Deviation dialog, fill the required fields.
Click Save.

EDC Interface and Veeva Terminology

Adverse Event (See Also “Serious Adverse Event”): Any untoward medical occurrence in a patient or clinical investigation subject who had a pharmaceutical product administered. These occurrences do not necessarily have a causal relationship with this treatment.
Breadcrumb: The breadcrumb is the list of hyperlinks a user sees at the top of certain page in EDC. These links may vary but they are links to other relevant sections of the study (such as Subject page, visits, forms etc..). This feature enables easy navigation of the platform.
Casebook: A detailed report of the diagnosis, treatment, and follow-up of an individual patient. Case reports also contain some demographic information about the patient (for example, age, gender, ethnic origin..).
Event: Visit (See definition in Clinical Trial Terminology)
Form: Forms are where the data collected is entered in EDC. The form structure and content varies from study to study based on the requirements of the studies.
Freezing a form: Means of preserving data in its current state. Typically, it occurs before or after data review activities are complete. Frozen data cannot be modified, but all other activities like Source Data Verification can still occur.
Item: Field
Locking a form: Means of preserving data in its current state. Typically, it occurs before or after data review activities are complete. Locked data cannot be modified and no other activities can occur on the data.
Serious Adverse Event: An adverse event or suspected adverse reaction is considered “serious” if, in the view of the investigator or sponsor, it results in any of the following outcomes: Death, life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/Birth defect.
Signature: Usually performed by the investigator as a means of affirming some action in the study
Site: Physical location where data is collected from the subject (This can be a clinic or hospital..)
Source Data Verification (SDV): This the process in EDC whereby the user with the sponsor role compares the data collected with the data entered in EDC for accuracy.
User query/ Auto query: Query that is manually added to a form by a user/ Query that is prompted on a form by the system. Auto query appears if a data entered does not fit within the specified requirements (The age of the subject may fall outside of the age range for a particular study for example).

2. Medidata Rave

Medidata Rave is a software platform used in the management and execution of clinical trials. It is a cloud-based system that provides tools for study design, data management, electronic data capture, and reporting. Rave is designed to help streamline the clinical trial process, including data management, compliance, and reporting, which can be used by sponsors, CROs, and sites. It can also be used for sites to collect patient data, manage study documents and monitor study progress. Medidata Rave is commonly used in the pharmaceutical, biotechnology and medical device industries.

Medidata Rave also includes features such as an e-signature function for informed consent forms, a randomization module, and a safety and adverse event tracking system. This allows for real-time monitoring and reporting of safety data during a clinical trial, which can help ensure patient safety and compliance with regulatory requirements. Additionally, Rave’s data management system allows for easy integration with other systems, such as electronic medical records and lab systems, which can help improve data quality and reduce errors. Overall, the use of Medidata Rave in clinical trials can help improve the efficiency and quality of the clinical trial process, which can ultimately lead to faster drug development and approval.

Medidata Rave Components:

Medidata Rave is a comprehensive software platform that includes several components to support the management and execution of clinical trials. Some of the key components of Medidata Rave that a user might interact with include:

Study Design: This component allows users to design and set up a study, including creating study forms, defining visit schedules, and setting up study groups and randomization schemes.
Data Management: This component allows users to manage and validate study data, including entering and reviewing data, monitoring data quality, and generating reports.
Electronic Data Capture: This component allows users to capture and submit study data electronically, including capturing data from patients and study sites.
Safety and Adverse Event Tracking: This component allows users to track and report safety data during a clinical trial, including capturing and reporting adverse events.
Reporting: This component allows users to generate study reports, including data summaries, safety reports, and study performance metrics.
e-Signature: This component allows users to capture electronic signatures from patients on informed consent forms.
Randomization: This component allows users to randomize patients to different groups or treatment arms within a study.
Mobile trial: Users can collect data from patients via their mobile devices and monitor study progress remotely.
Global trial: Users can ensure compliance with local regulatory requirements and conduct study in multiple languages.
Adaptive trial: Users can make data-driven decisions during the trial such as adjusting the trial design or stopping the trial early if certain criteria are met.

These are some of the components that a user might interact with while using Medidata Rave, but it should be noted that the platform is highly configurable and can be tailored to the specific needs of a study or organization.

In addition to the components mentioned above, Medidata Rave also includes several other tools and features that can help improve the clinical trial process. Some of these additional features include:

Document Management: This feature allows users to manage and track study documents, such as protocols, case report forms, and informed consent forms.
Audit Trail: This feature allows users to track changes made to study data and documents, which can help ensure compliance and data integrity.
Data Integration: This feature allows users to integrate Rave with other systems, such as electronic medical records and lab systems, which can help improve data quality and reduce errors.
Data Quality Checks: This feature allows users to set up data quality checks and validations to ensure that data entered into the system is accurate and complete.
Study Monitoring: This feature allows users to monitor study progress and performance, including patient enrollment, data completeness, and site performance.
Study Management: This feature allows users to manage study related activities and communications, such as site management, patient management, and financial management.
Study Management Dashboard: This feature provides a summary view of the study performance and progress
Study Performance Metrics: This feature allows users to track and analyze study performance metrics, such as patient enrollment, data completeness, and site performance.
Alerts & Notifications: This feature allows users to set up and receive alerts and notifications for specific events or conditions, such as data quality issues, patient enrollment milestones, or regulatory deadlines.
Role-based access control: This feature allows users to have access to the system and its functionalities based on their role, which helps to ensure security and compliance.

Overall, Medidata Rave provides a comprehensive set of tools and features that can help improve the efficiency and quality of the clinical trial process. It is widely used in the pharmaceutical, biotech, and medical device industries, and can be tailored to the specific needs of a study or organization.