Average Ratings 0 Ratings
Average Ratings 0 Ratings
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
No
API Access
Has API
No
Screenshots View All
No images available
Integrations
LifeSphere CTMS
Yes
LifeSphere EDC
Yes
LifeSphere RIMS
Yes
elsai
No
Integrations
LifeSphere CTMS
No
LifeSphere EDC
No
LifeSphere RIMS
No
elsai
Yes
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
No price information available.
Free Trial
Yes
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
Yes
iPhone App
No
iPad App
No
Android App
No
Windows
Yes
Mac
Yes
Linux
Yes
Chromebook
Yes
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
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
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
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