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ease
features
design
support

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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 No 

API Access

Has API Yes 

Screenshots View All

Screenshots View All

Integrations

Microsoft 365 No 

Integrations

Microsoft 365 Yes 

Pricing Details

$79
Contact Sarjen Systems Pvt Ltd.
Free Trial No 
Free Version No 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises Yes 
iPhone App No 
iPad App No 
Android App No 
Windows Yes 
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 Yes 
Live Rep (24/7) Yes 
Online Support Yes 

Customer Support

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

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Types of Training

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

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 Yes 
Document Management Yes 
Electronic Data Capture Yes 
Enrollment Management Yes 
HIPAA Compliant Yes 
Monitoring Yes 
Patient Database Yes 
Recruiting Management Yes 
Scheduling Yes 
Study Planning Yes 

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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