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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
Trialpack Designer is a user-friendly yet robust application designed for creating blister packs and cards specifically for clinical trials. This tool excels in designing packaging for intricate blinded studies, including dosage titrations, double-dummy setups, and cross-over trials, where a single pack may contain various products. It seamlessly supplies configuration information for the Trialpack PC Controller, the Controlled Dosing Systems, and the Robotic Packaging Systems. Users can easily create blister shapes, print images, and filling patterns directly on the screen. Additionally, it offers highly detailed user access controls, efficient workflow capabilities with electronic signatures, and a comprehensive audit trail that complies with 21 CFR Part 11 regulations. The system also generates reports that provide in-depth packaging instructions along with a breakdown of material requirements, ensuring thorough documentation and compliance for trial processes. This multifaceted tool is essential for maintaining the integrity and organization of clinical trial packaging.
API Access
Has API
API Access
Has API
Integrations
No details available.
Integrations
No details available.
Pricing Details
No price information available.
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
Astracore
Founded
2010
Country
Australia
Website
astracore.com/medical/clinical/
Vendor Details
Company Name
Fleximation
Founded
1994
Country
Switzerland
Website
www.fleximation.com/trialpack/designer/index.html
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