Average Ratings 0 Ratings
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
ClinSoft™, was developed in-house by Innovate Research. There were no third-party acquisitions and integrations. The system is compliant to FDA regulations (21 CFR Part 11, as well as GCP and HIPAA. The system is fully auditable and validated. ClinSoft™, which is easy to use, ensures quick start-ups and close-outs. This saves you precious time and allows you to be certain that any mid-study amendments or updates to protocols will be made promptly. Innovate Research, an Indian contract research company, provides services in clinical research and regulatory affairs. US FDA 21 CFR Part 11 compliant. Electronic Signatures & Records Secure, Role-Based Access. Audit Trail. Easy to use interface for Edit Checks and CRF Set-up. Frameworks that can be reused for item, panel, visit, and page.
API Access
Has API
No
API Access
Has API
No
Integrations
No details available.
Integrations
No details available.
Pricing Details
$79
Contact Sarjen Systems Pvt Ltd.
Free Trial
No
Free Version
No
Pricing Details
No price information available.
Free Trial
Yes
Free Version
Yes
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
Yes
iPad App
Yes
Android App
Yes
Windows
Yes
Mac
Yes
Linux
Yes
Chromebook
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
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
Yes
Vendor Details
Company Name
Sarjen Systems Pvt Ltd
Founded
1998
Country
India
Website
biznet.sarjen.com
Vendor Details
Company Name
Innovate Research
Founded
2014
Country
India
Website
innovate-research.com/clinsoft/
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
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