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ease
features
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support

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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

The elsai Clinical Protocol Audit Agent assists clinical and regulatory teams in ensuring that protocols, consent documents, and recruitment materials are properly aligned with governance standards prior to IRB submission. This innovative tool offers artificial intelligence-driven validation across multiple documents, tracks amendments and versions, identifies discrepancies automatically, provides governance and audit traceability, and delivers IRB-prepared review summaries. Additionally, it seamlessly integrates with CTMS, eIRB, eTMF, as well as Word and Google Docs workflows, enhancing overall efficiency and compliance in the clinical trial process. Its comprehensive features make it an invaluable asset for teams aiming to streamline their regulatory submissions.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

No images available

Integrations

LifeSphere CTMS
LifeSphere EDC
LifeSphere RIMS
elsai

Integrations

LifeSphere CTMS
LifeSphere EDC
LifeSphere RIMS
elsai

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

No price information available.
Free Trial
Free Version

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Vendor Details

Company Name

ArisGlobal

Founded

1987

Country

United States

Website

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

Vendor Details

Company Name

elsai

Founded

2007

Country

United States

Website

www.elsai.ai/agents/clinical-protocol-audit-agent

Product 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

Product Features

Alternatives

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Alternatives

No Alternatives
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