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ease
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

adWATCH - AE is a solution designed to aid pharmaceutical companies in handling and documenting adverse events that arise during clinical trials. It provides a quick and efficient way for reporters at clinics, hospitals, or investigative sites to create and oversee Adverse Event Reports (AERs), ensuring proper reporting to regulatory bodies and government organizations. An adverse effect refers to a harmful or undesirable reaction experienced by a patient due to medications or medical devices. The process of documenting adverse events necessitates thorough tracking of all medical complaint case details, which culminates in the creation of MedWatch reports, CIOMS reports, and other management documentation. With adWATCH - AE, researchers, physician investigators, Contract Research Organizations (CROs), clinical trial experts, and various health professionals can easily generate and submit AERs in compliance with FDA requirements, adhering to both MedWatch and CIOMS formats. This streamlined process not only enhances regulatory compliance but also improves patient safety oversight during clinical trials.

API Access

Has API

API Access

Has API

Screenshots View All

No images available

Screenshots View All

Integrations

No details available.

Integrations

No details available.

Pricing Details

$300
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

Folio3 Digital Health

Founded

2005

Country

United States

Website

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

Vendor Details

Company Name

Atlant Systems

Website

atlantsystems.com/atlant/solutions/atwatch-ae/

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

CAPA

Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management

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