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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 Agatha?

Agatha offers a wide array of cloud-based solutions meticulously tailored for the life sciences industry, which enables the centralized management of documents and processes associated with clinical operations, quality assurance, regulatory compliance, and training initiatives. This innovative platform is designed to support the unique workflows of biotech companies, pharmaceutical enterprises, medical device producers, and contract research organizations, providing various modules such as eTMF (Inspection-Ready Master Trial File), Remote ISF (Investigator Site File) management, and tools for developing and approving standard operating procedures (SOPs), in addition to managing quality documents for CAPAs, deviations, and change controls. Furthermore, Agatha streamlines the handling of regulatory documents, ensuring the seamless creation, review, approval, storage, and sharing of materials within an integrated system. By advocating for a paperless environment, it reduces administrative burdens and enhances data security, all while being built on a framework that adheres to global compliance standards like 21 CFR Part 11, GDPR, and EU Annex 11. Ultimately, Agatha equips life sciences organizations with the tools necessary to refine their operations and uphold adherence to industry regulations more effectively, paving the way for improved efficiency and innovation in the sector. With its robust features, the platform not only simplifies complex processes but also supports organizations in achieving their strategic goals.

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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

24 Hour 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

Agatha

Date Founded

2015

Company Location

United States

Company Website

en.agathalife.com

Categories and Features

Research Management

Not specified

Categories and Features

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