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What is Datatrial Nucleus?

Explore an all-encompassing platform tailored for the seamless research, documentation, and organization of your clinical data. The Nucleus platform simplifies the management of your research data by offering a cohesive environment for the storage of study documentation, clinical datasets, submission materials, and compliant media. With Nucleus Documents, you can adeptly handle documents while ensuring version control for your quality documentation and media assets. You can manage, oversee, and share your organizational content effortlessly, making collaboration smoother than ever. Moreover, you can easily gather and regulate your electronic trial master file documents through our centralized regulatory document management system. Nucleus Coding provides dictionary term coding for both MedDRA and WHODrug dictionaries as a standalone application or integrated within your data capture system, thus offering flexibility and efficiency in your coding processes. This robust solution not only bolsters data integrity but also fosters improved collaboration among your research teams, ensuring that everyone stays informed and aligned. Additionally, the platform’s user-friendly interface enhances overall usability, making it an invaluable tool for clinical research professionals.

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.

Media

Media

Integrations Supported

LifeSphere CTMS
LifeSphere EDC
LifeSphere RIMS

Integrations Supported

LifeSphere CTMS
LifeSphere EDC
LifeSphere RIMS

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Datatrial

Date Founded

1999

Company Location

United Kingdom

Company Website

www.datatrial.com/nucleus/

Company Facts

Organization Name

ArisGlobal

Date Founded

1987

Company Location

United States

Company Website

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

Categories and Features

Clinical Trial Management

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

Categories and Features

Clinical Trial Management

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

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