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Average Ratings 0 Ratings

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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

OpenClinica is a leading provider of clinical data management software solutions. OpenClinica provides powerful tools to ensure that clinical trials are compliant and efficient. OpenClinica Enterprise, OpenClinica Participate and OpenClinica Randomize are the core products. OpenClinica is a powerful clinical trial platform that offers a wide range of tools for data collection, patient engagement, and study management. From electronic data capture (EDC) and eConsent to patient recruitment and real-time reporting, OpenClinica’s solutions automate and simplify the clinical trial process. With features like EHR-to-EDC integration and advanced reporting dashboards, the platform improves data accuracy, reduces delays, and enhances compliance. OpenClinica has been used in over 15,000 clinical studies, providing support for organizations around the globe, including government agencies and pharmaceutical companies, to conduct trials with confidence.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

BioGRID
ClinVigilant
Res_Q

Integrations

BioGRID
ClinVigilant
Res_Q

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

OpenClinica

Founded

2006

Country

United States

Website

www.openclinica.com

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

Electronic Data Capture

Audit Trail
CRF Tracking
Data Entry
Data Verification
Distributed Capture
Document Imaging
Document Indexing
Forms Management
Remote Capture
Study Management

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