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Average Ratings 0 Ratings

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ease
features
design
support

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Write a Review

Description

LifeSphere eTMF serves as the definitive source of truth for your clinical trial. Experience a flexible solution that simplifies inspections, guarantees compliance, and reduces the time and effort required by your organization. As the pioneering system designed to adhere to the TMF reference model, LifeSphere eTMF integrates clinical documentation with regulatory requirements and study protocols into a unified platform. Establish and oversee a singular source of truth for your clinical trial to enhance efficiency. With features that promote live collaboration and real-time document sharing, you can ensure the quality, timeliness, and completeness of your trial master file. Expedite TMF inspections swiftly and effectively to manage audits seamlessly. Furthermore, uphold compliance through built-in workflows and intuitive dashboards that facilitate straightforward trial reconstruction, making the process smoother for all stakeholders involved.

Description

Enhance the efficiency of regulatory operations within your organization to bolster compliance and facilitate research advancements. Veeva SiteVault simplifies the process of managing clinical trials by integrating your regulatory tasks, leading to improved effectiveness and adherence to regulations. You can oversee regulatory and source documents through a unified platform that complies with 21 CFR Part 11 and HIPAA standards. With real-time insights across all trials, SiteVault Enterprise boosts operational effectiveness, accelerates study initiation, and fosters swift, high-quality trial management. Transition away from manual workflows and customize your own processes to enhance both quality and speed in study activation. By granting monitors secure, direct access to your regulatory and source documents, you eliminate the hassles of EMR access and document redaction. Furthermore, you can tailor your workflows, generate reports, and create dashboards to gain deeper insights into start-up timelines and regulatory workflows, ultimately driving better outcomes for your clinical trials. This comprehensive approach not only streamlines processes but also enhances collaboration across teams.

API Access

Has API No 

API Access

Has API Yes 

Screenshots View All

Screenshots View All

Integrations

LifeSphere CTMS Yes 
LifeSphere EDC Yes 
LifeSphere RIMS Yes 
Microsoft 365 No 

Integrations

LifeSphere CTMS No 
LifeSphere EDC No 
LifeSphere RIMS No 
Microsoft 365 Yes 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours No 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours No 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) No 
In Person No 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person No 

Vendor Details

Company Name

ArisGlobal

Founded

1987

Country

United States

Website

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

Vendor Details

Company Name

Veeva Systems

Country

United States

Website

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

Product Features

Clinical Trial Management

21 CFR Part 11 Compliance No 
Document Management No 
Electronic Data Capture No 
Enrollment Management No 
HIPAA Compliant No 
Monitoring No 
Patient Database No 
Recruiting Management No 
Scheduling No 
Study Planning No 

Product Features

Clinical Trial Management

21 CFR Part 11 Compliance No 
Document Management No 
Electronic Data Capture No 
Enrollment Management No 
HIPAA Compliant No 
Monitoring No 
Patient Database No 
Recruiting Management No 
Scheduling No 
Study Planning No 

Scientific Data Management System (SDMS)

Analytics No 
Artificial Intelligence (AI) No 
Audit No 
Centralized Data Repository No 
Collaboration No 
Compliance No 
Data Security No 
ELN Integration No 
LIMS Integration No 
Workflows No 

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