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Average Ratings 0 Ratings
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.
Description
eProtocol serves as a comprehensive online platform dedicated to research compliance for various institutions overseeing human subjects, animals, biosafety, and other regulated studies. This system facilitates the development and electronic submission of protocols, as well as the workflows for committee review and approval, amendments, renewals, reporting of adverse events, automated routing and reminders, version control, meeting agendas and minutes, audit trails, and comprehensive reporting. Users such as investigators, coordinators, reviewers, and compliance administrators can efficiently monitor protocol statuses and access relevant records through a collaborative interface. The platform features specific modules tailored for IRB, IACUC, IBC, stem-cell research, chemical safety, radiation safety, controlled substances, and post-approval monitoring processes. eProtocol is specifically crafted to meet the needs of universities, research institutions, hospitals, academic medical centers, biotech and pharmaceutical companies, as well as governmental research agencies, ensuring a streamlined approach to compliance across diverse research environments. Additionally, it enhances the overall efficiency of regulatory processes, ultimately contributing to the integrity and safety of research activities.
API Access
Has API
No
API Access
Has API
No
Screenshots View All
No images available
Integrations
No details available.
Integrations
No details available.
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
Yes
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)
No
Online Support
Yes
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
No
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
No
Types of Training
Training Docs
No
Webinars
No
Live Training (Online)
No
In Person
No
Vendor Details
Company Name
Atlant Systems
Website
atlantsystems.com/atlant/solutions/atwatch-ae/
Vendor Details
Company Name
Key Solutions
Founded
1991
Country
United States
Website
www.keyusa.com
Product Features
CAPA
Audit Management
No
CAPA Planning
No
Change Management
No
Complaint Management
No
Incident Management
No
Nonconformance Tracking
No
Quality Control
No
Risk Management
No
Root Cause Analysis
No
Training Management
No