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features
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Description

Folio3 Digital Health offers an all-encompassing Clinical Trial Management Software (CTMS) that is a web-based solution aimed at enhancing the efficiency of the entire clinical trial lifecycle for pharmaceutical firms, contract research organizations (CROs), and research institutions. This platform consolidates various trial operations, facilitating everything from planning and site oversight to data gathering and reporting, while ensuring adherence to international regulations such as FDA 21 CFR Part 11, GxP, and HIPAA. With a focus on delivering user-friendly interface designs, real-time dashboards, and adaptable modules, the software is capable of managing clinical trials of any scale effectively. The system includes specialized modules for study initiation, allowing users to outline protocols, timelines, and budgets using customizable templates tailored to their needs. Moreover, the site management features enable tracking of investigator credentials, contracts, and financial transactions, in addition to patient recruitment tools that streamline screening, monitoring of enrollment, and scheduling of visits, complete with automated reminders to enhance participant engagement. Notably, the platform’s versatility makes it suitable for various stakeholders involved in clinical research, thereby promoting a more integrated and efficient trial management experience.

Description

In recent years, the Life Sciences sector has incurred nearly $15 billion in fines and settlements related to compliance, underscoring the importance for firms to follow best practices in pharmaceuticals, medical devices, and biotechnology. Additionally, the way clinical trials are managed can greatly influence the timeline, scope, and financial resources allocated for the development of drugs or medical devices. Utilizing OpenText™ Clinical Trial Quality Management System (ctQMS) allows organizations to maintain compliance, lower record management expenses, and foster collaboration to implement best practices throughout the entire clinical trial lifecycle. This strategic approach not only enhances operational efficiency but also contributes to the overall success of product development initiatives.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

No images available

Screenshots View All

No images available

Integrations

No details available.

Integrations

No details available.

Pricing Details

$300
Free Trial No 
Free Version No 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises Yes 
iPhone App Yes 
iPad App Yes 
Android App Yes 
Windows Yes 
Mac Yes 
Linux No 
Chromebook Yes 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours No 
Live Rep (24/7) Yes 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs No 
Webinars No 
Live Training (Online) No 
In Person No 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) No 
In Person No 

Vendor Details

Company Name

Folio3 Digital Health

Founded

2005

Country

United States

Website

digitalhealth.folio3.com/solutions/clinical-trial-management-software/

Vendor Details

Company Name

OpenText

Founded

1991

Country

Canada

Website

www.opentext.com/info/clinical-trial-management

Product Features

Clinical Trial Management

21 CFR Part 11 Compliance No 
Document Management No 
Electronic Data Capture No 
Enrollment Management No 
HIPAA Compliant No 
Monitoring No 
Patient Database No 
Recruiting Management No 
Scheduling No 
Study Planning No 

Product Features

Clinical Trial Management

21 CFR Part 11 Compliance No 
Document Management No 
Electronic Data Capture No 
Enrollment Management No 
HIPAA Compliant No 
Monitoring No 
Patient Database No 
Recruiting Management No 
Scheduling No 
Study Planning No 

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