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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 LifeSphere eTMF?

LifeSphere eTMF stands out as the ultimate reference point for your clinical trial needs. This adaptable solution streamlines inspections, assures compliance, and significantly lessens the workload for your organization. Being the first system tailored to meet the TMF reference model, LifeSphere eTMF seamlessly merges clinical documentation with regulatory standards and study protocols into a cohesive platform. By establishing a single source of truth for your clinical trial, you can significantly boost operational efficiency. Its features foster live collaboration and enable real-time document sharing, ensuring that your trial master file is maintained with high quality, punctuality, and completeness. You can facilitate TMF inspections quickly and effectively, making audit management a breeze. In addition, the system supports compliance through its embedded workflows and user-friendly dashboards, which simplify the trial reconstruction process, creating a smoother experience for all parties involved. Ultimately, LifeSphere eTMF not only enhances the efficiency of clinical trials but also strengthens the integrity of the entire research process.

Media

Media

Integrations Supported

LifeSphere CTMS
LifeSphere EDC
LifeSphere RIMS
Microsoft 365

Integrations Supported

LifeSphere CTMS
LifeSphere EDC
LifeSphere RIMS
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

ArisGlobal

Date Founded

1987

Company Location

United States

Company Website

lifesphere.arisglobal.com/platform/clinical/etmf/

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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