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What is eProtocol?

eProtocol is an all-encompassing online platform designed for research compliance, catering to various institutions that manage studies involving human subjects, animals, biosafety, and other regulated areas. This system streamlines the creation and electronic submission of research protocols while managing the workflows needed for committee review, approval, amendments, renewals, and reporting of adverse events, along with features like automated routing, reminders, version control, meeting agendas, minutes, audit trails, and detailed reporting. Investigators, coordinators, reviewers, and compliance administrators benefit from a collaborative interface that allows them to effectively track protocol statuses and access essential records. The platform includes specialized modules for Institutional Review Boards (IRB), Institutional Animal Care and Use Committees (IACUC), Institutional Biosafety Committees (IBC), as well as for stem-cell research, chemical safety, radiation safety, controlled substances, and post-approval monitoring. eProtocol is meticulously designed to cater to the specific needs of universities, research institutions, hospitals, academic medical centers, biotech and pharmaceutical firms, and governmental research entities, ensuring an efficient compliance process across a variety of research landscapes. Furthermore, it not only boosts the efficiency of regulatory processes but also plays a crucial role in enhancing the overall integrity and safety of research activities, fostering a culture of accountability and transparency in scientific inquiry.

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.

Media

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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
On-Prem

Supported Platforms

SaaS

Customer Service / Support

Not specified

Customer Service / Support

Web-Based Support

Training Options

Not specified

Training Options

Documentation Hub
Online Training

Company Facts

Organization Name

Key Solutions

Date Founded

1991

Company Location

United States

Company Website

www.keyusa.com

Company Facts

Organization Name

Atlant Systems

Company Website

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

Categories and Features

Research Management

Not specified

Categories and Features

CAPA

Not specified

Drug Discovery

Not specified

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