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What is Veeva SiteVault?

Improve the efficiency of regulatory operations within your organization to strengthen compliance and promote research progress. Veeva SiteVault streamlines the management of clinical trials by consolidating regulatory responsibilities, resulting in heightened effectiveness and adherence to necessary regulations. You can manage regulatory and source documents through a single platform that meets 21 CFR Part 11 and HIPAA requirements. With real-time data across all trials, SiteVault Enterprise enhances operational performance, speeds up study initiation, and supports rapid, high-quality trial management. Move away from manual processes and personalize your workflows to improve both quality and speed in study activation. By providing monitors with secure, direct access to your regulatory and source documents, you eliminate the complications associated with EMR access and document redaction. Additionally, you can customize your workflows, create reports, and develop dashboards that offer valuable insights into start-up timelines and regulatory processes, ultimately driving improved results for your clinical trials. This holistic strategy not only simplifies processes but also fosters greater collaboration among teams, enabling better communication and efficiency throughout the trial phases. As a result, your organization can achieve its research goals while maintaining rigorous compliance standards.

What is MAISi?

Traditionally, the oversight of clinical trials at investigator sites has been a burdensome process, reliant on either the management of multiple shared spreadsheets or the high costs associated with software that often lacked relevance to the Australian setting. MAISi marks a significant advancement in this domain. Initially developed in 2001 as a data repository for clinical trials at a leading hospital, MAISi has evolved into a sophisticated workflow application aimed at optimizing various functions within research units. Acting as a centralized information hub, MAISi organizes data related to studies alongside the business units responsible for their management. This organized framework enhances the decision-making processes for management. Team members within each unit can access relevant information concerning their specific studies, patients, investigators, and study teams, while those with elevated access rights, such as Financial Officers and System Administrators, have the ability to retrieve detailed information across all units. Moreover, this efficient access not only fosters collaboration but also significantly boosts overall operational effectiveness, making MAISi an indispensable tool in modern clinical trial management. With its user-friendly design and tailored functionalities, MAISi is poised to redefine how clinical research is conducted in Australia.

Media

Media

Integrations Supported

Microsoft 365

Integrations Supported

Microsoft 365

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Veeva Systems

Company Location

United States

Company Website

sites.veeva.com/products/sitevault-enterprise/

Company Facts

Organization Name

Agile Health Computing

Company Location

Australia

Company Website

www.agilehealthcomputing.com

Categories and Features

Clinical Trial Management

21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning

Scientific Data Management System (SDMS)

Analytics
Artificial Intelligence (AI)
Audit
Centralized Data Repository
Collaboration
Compliance
Data Security
ELN Integration
LIMS Integration
Workflows

Categories and Features

Clinical Trial Management

21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning

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