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What is eDeviation?

eDeviation offers a thorough suite of tools designed for the evaluation and management of Protocol Deviations, simplifying the journey from software development and validation to the collection of essential documentation and the exportation of data for the Trial Master File (TMF). This innovation significantly reduces the workload on clinical teams who may encounter risks associated with poorly evaluated or neglected protocol deviations, regardless of their frequency. As part of Ethical's eClinical Software Platforms, eDeviation® improves the precision and productivity of clinical trial oversight. The software can be customized to fit the unique needs of your research team, whether assessments are made by an independent committee or internally. Its built-in forms, workflows, and export capabilities guarantee compliance with GxP standards while promoting effective study management. Moreover, the platform supports real-time online collaboration among study teams, investigators’ sites, and committee members, which accelerates decision-making and ensures that protocol deviation assessments are addressed promptly. This collaborative environment not only streamlines processes but also fosters a culture of transparency and accountability in clinical trials. Ultimately, eDeviation® plays a crucial role in enhancing the integrity and efficiency of clinical research processes, leading to improved research outcomes.

What is MAISi?

Traditionally, the oversight of clinical trials at investigator sites has been a burdensome process, reliant on either the management of multiple shared spreadsheets or the high costs associated with software that often lacked relevance to the Australian setting. MAISi marks a significant advancement in this domain. Initially developed in 2001 as a data repository for clinical trials at a leading hospital, MAISi has evolved into a sophisticated workflow application aimed at optimizing various functions within research units. Acting as a centralized information hub, MAISi organizes data related to studies alongside the business units responsible for their management. This organized framework enhances the decision-making processes for management. Team members within each unit can access relevant information concerning their specific studies, patients, investigators, and study teams, while those with elevated access rights, such as Financial Officers and System Administrators, have the ability to retrieve detailed information across all units. Moreover, this efficient access not only fosters collaboration but also significantly boosts overall operational effectiveness, making MAISi an indispensable tool in modern clinical trial management. With its user-friendly design and tailored functionalities, MAISi is poised to redefine how clinical research is conducted in Australia.

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

Windows

Customer Service / Support

Not specified

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Not specified

Training Options

Documentation Hub
Online Training

Company Facts

Organization Name

eDeviation

Company Website

www.protocoldeviation.com/eDeviation-software

Company Facts

Organization Name

Agile Health Computing

Company Location

Australia

Company Website

www.agilehealthcomputing.com

Categories and Features

Categories and Features

Clinical Trial Management

21 CFR Part 11 Compliance
Document Management
Enrollment Management
HIPAA Compliant
Patient Database
Recruiting Management
Scheduling
Study Planning

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