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What is LifeSphere eTMF?

LifeSphere eTMF stands out as the ultimate reference point for your clinical trial needs. This adaptable solution streamlines inspections, assures compliance, and significantly lessens the workload for your organization. Being the first system tailored to meet the TMF reference model, LifeSphere eTMF seamlessly merges clinical documentation with regulatory standards and study protocols into a cohesive platform. By establishing a single source of truth for your clinical trial, you can significantly boost operational efficiency. Its features foster live collaboration and enable real-time document sharing, ensuring that your trial master file is maintained with high quality, punctuality, and completeness. You can facilitate TMF inspections quickly and effectively, making audit management a breeze. In addition, the system supports compliance through its embedded workflows and user-friendly dashboards, which simplify the trial reconstruction process, creating a smoother experience for all parties involved. Ultimately, LifeSphere eTMF not only enhances the efficiency of clinical trials but also strengthens the integrity of the entire research process.

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.

Media

Media

Integrations Supported

LifeSphere CTMS
LifeSphere EDC
LifeSphere RIMS

Integrations Supported

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

24 Hour Support
Web-Based Support

Training Options

Documentation Hub

Training Options

Documentation Hub
Online Training

Company Facts

Organization Name

ArisGlobal

Date Founded

1987

Company Location

United States

Company Website

lifesphere.arisglobal.com/platform/clinical/etmf/

Company Facts

Organization Name

Agatha

Date Founded

2015

Company Location

United States

Company Website

en.agathalife.com

Categories and Features

Categories and Features

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