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What is ClinSoft?

ClinSoftâ„¢, created internally by Innovate Research, does not involve any external acquisitions or integrations. The software adheres to FDA regulations, including 21 CFR Part 11, GCP, and HIPAA standards, ensuring it is both fully auditable and validated. This user-friendly system facilitates rapid start-up and close-out processes, allowing you to save valuable time and guaranteeing that any amendments or updates to study protocols are implemented efficiently. As a contract research organization based in India, Innovate Research specializes in clinical research and regulatory affairs, ensuring compliance with US FDA 21 CFR Part 11. The platform features secure electronic signatures and records, role-based access control, and an audit trail. Moreover, it includes an intuitive interface for editing checks and setting up case report forms (CRFs), along with reusable frameworks for items, panels, visits, and pages, enhancing usability and efficiency for clinical trials. Additionally, the comprehensive design of ClinSoftâ„¢ supports streamlined workflows, ultimately improving overall productivity in clinical research operations.

What is ClinAccess?

ClinAccess™ 5.1 marks a significant advancement in our leading Clinical Data Management System, which is entirely constructed on the powerful SAS® 9 framework. This cutting-edge system enhances the efficiency of clinical data management, streamlines the analysis of clinical trials, and simplifies the preparation of electronic submissions. By allowing data entry to be performed directly into SAS® data sets, it eliminates the tedious task of transferring data from Oracle/SQL to SAS, greatly increasing your team's productivity. ClinAccess™ is designed with user-friendly features for study definitions, data entry, and management, including tools that monitor the progress and quality of ongoing clinical trials. Your data remains consistently organized within SAS® for straightforward access, whether it’s for review, analysis, or submission to regulatory bodies like the FDA. The database architecture is finely tuned to enable swift statistical analysis and reporting, ensuring users experience a significant reduction in the time and effort needed for data analysis, which can accelerate the overall time to market. Furthermore, ClinAccess™ is distinguished by its reliability, extensive auditing functionalities, and strong security protocols, making it an exceptional option for managing clinical data. With ClinAccess™, you can adeptly handle the intricacies of clinical trials while upholding data integrity and compliance standards, thereby ensuring the success of your research endeavors. This comprehensive system empowers organizations to achieve milestones with confidence in their data management processes.

Media

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Innovate Research

Date Founded

2014

Company Location

India

Company Website

innovate-research.com/clinsoft/

Company Facts

Organization Name

MAJARO InfoSystems

Date Founded

1987

Company Location

United States

Company Website

www.majaro.com/html/clinical-data-management-software/clinaccess.html

Categories and 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

Categories and 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

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