Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
Our clinical trials management platform is designed to accommodate nearly any type of controlled clinical trial, including those that are randomized, and offers a variety of randomization algorithms. This software can be effortlessly set up for both paper Clinical Report Forms (CRFs) and electronic CRFs (eCRFs). It is capable of capturing data in numerous formats and methods, applying specific guidelines you establish to ensure data integrity and quality control. The system facilitates direct Electronic Data Capture (EDC) through eCRFs or allows for the printing of paper CRFs that can later be input into the platform. Additionally, users can upload various media such as images, audio, video, and documents like consent forms, with the only limitation being the available storage capacity. The system supports Double Data Entry and features comprehensive exception reporting. Moreover, it includes a functionality to lock records after they have been verified, ensuring that no further alterations can be made. This robust capability enhances the overall integrity of the data collected throughout the trial process.
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
No price information available.
Free Trial
Yes
Free Version
No
Pricing Details
No price information available.
Free Trial
Yes
Free Version
Yes
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
Yes
iPad App
Yes
Android App
Yes
Windows
No
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)
No
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
No
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
Astracore
Founded
2010
Country
Australia
Website
astracore.com/medical/clinical/
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
No
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