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Average Ratings 0 Ratings

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ease
features
design
support

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Write a Review

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 

Screenshots View All

Screenshots View All

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 

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