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Average Ratings 0 Ratings
Description
Accelerate clinical innovation with an AI-enabled Clinical Research Platform designed to unify Early Phase CTMS, Late Phase CTMS, and Bioanalytical LIMS into a single, intelligent ecosystem. Built for pharmaceutical, biotechnology, CRO, and research organizations, the platform supports the complete clinical development lifecycle—from protocol planning, volunteer and patient management, site operations, and subject scheduling to sample lifecycle management, bioanalytical testing, data review, and regulatory submissions.By connecting clinical and laboratory operations on a centralized platform, organizations gain real-time visibility, standardized workflows, and end-to-end traceability across studies. AI-enabled capabilities deliver intelligent workflow automation, predictive analytics, smart data validation, anomaly detection, and actionable insights that help research teams identify risks early, optimize resource utilization, reduce manual effort, and make faster, data-driven decisions. Automated alerts, configurable dashboards, and role-based workflows improve operational efficiency while ensuring data integrity and study oversight.Designed to support GxP, GLP, GCP, and 21 CFR Part 11 compliance, the platform provides comprehensive audit trails, electronic records and signatures, secure data management, and seamless interoperability with enterprise systems such as EDC, eTMF, ERP, and laboratory instruments. Its scalable, configurable architecture adapts to diverse study designs and organizational needs, enabling sponsors and CROs to streamline clinical operations, shorten study timelines, enhance collaboration, and deliver high-quality, inspection-ready data with confidence.
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
API Access
Has API
Integrations
Microsoft 365
Pricing Details
$79
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
Sarjen Systems Pvt Ltd
Founded
1998
Country
India
Website
biznet.sarjen.com
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
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning
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
Scientific Data Management System (SDMS)
Analytics
Artificial Intelligence (AI)
Audit
Centralized Data Repository
Collaboration
Compliance
Data Security
ELN Integration
LIMS Integration
Workflows