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What is adWATCH?

adWATCH - AE serves as a comprehensive solution for pharmaceutical companies to effectively manage and document adverse events that may occur throughout clinical trials. It offers a rapid and streamlined method for individuals at clinics, hospitals, or research sites to generate and monitor Adverse Event Reports (AERs), ensuring that all necessary information is accurately relayed to regulatory authorities and governmental entities. An adverse event is defined as any harmful or negative reaction a patient experiences as a result of medications or medical devices. The meticulous documentation of these adverse events requires detailed tracking of all medical case specifics, which leads to the production of essential reports such as MedWatch and CIOMS. With the implementation of adWATCH - AE, researchers, physician investigators, Contract Research Organizations (CROs), and various healthcare professionals can efficiently create and submit AERs that comply with FDA standards, following the formats established by both MedWatch and CIOMS. This organized approach not only bolsters adherence to regulatory guidelines but also significantly enhances the oversight of patient safety during the course of clinical trials. Furthermore, the tool's user-friendly interface facilitates collaboration among multiple stakeholders, contributing to a more transparent and accountable research environment.

What is GoResearch?

GoResearchâ„¢ is a sophisticated and rigorously tested online platform crafted by 2KMM for electronic data capture (EDC), tailored specifically for various research projects such as clinical trials, observational studies, and patient registries. It offers an extensive range of features that streamline these projects across different areas, including the ability to customize data workflows and manage procedures related to Adverse Events, complete with automated email notifications to safety teams. Moreover, the platform integrates a randomization module that allows for the random assignment of participants to treatment groups, while also enabling data collection through custom electronic case report forms (eCRF) that cater to the unique requirements of each study. In addition, GoResearchâ„¢ supports the incorporation of ePRO, eSource, and mHealth data through dedicated mobile and web applications, and features a flexible application programming interface (API). The aim of this platform is to significantly improve the efficiency and precision of data management in various research environments, ultimately contributing to more reliable outcomes in studies. By providing these robust tools, GoResearchâ„¢ empowers researchers to focus on their core objectives while ensuring that data integrity and compliance are maintained throughout the research process.

Media

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

API Availability

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub
Online Training

Training Options

Documentation Hub
Online Training

Company Facts

Organization Name

Atlant Systems

Company Website

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

Company Facts

Organization Name

2KMM

Company Location

Poland

Company Website

www.2kmm.pl/en/

Categories and Features

CAPA

Not specified

Drug Discovery

Not specified

Categories and Features

Electronic Data Capture

Audit Trail
CRF Tracking
Data Entry
Data Verification
Distributed Capture
Document Imaging
Document Indexing
Study Management

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