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Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

Description

LifeSphere eTMF serves as the definitive source of truth for your clinical trial. Experience a flexible solution that simplifies inspections, guarantees compliance, and reduces the time and effort required by your organization. As the pioneering system designed to adhere to the TMF reference model, LifeSphere eTMF integrates clinical documentation with regulatory requirements and study protocols into a unified platform. Establish and oversee a singular source of truth for your clinical trial to enhance efficiency. With features that promote live collaboration and real-time document sharing, you can ensure the quality, timeliness, and completeness of your trial master file. Expedite TMF inspections swiftly and effectively to manage audits seamlessly. Furthermore, uphold compliance through built-in workflows and intuitive dashboards that facilitate straightforward trial reconstruction, making the process smoother for all stakeholders involved.

Description

Trialpack Designer is a user-friendly yet robust application designed for creating blister packs and cards specifically for clinical trials. This tool excels in designing packaging for intricate blinded studies, including dosage titrations, double-dummy setups, and cross-over trials, where a single pack may contain various products. It seamlessly supplies configuration information for the Trialpack PC Controller, the Controlled Dosing Systems, and the Robotic Packaging Systems. Users can easily create blister shapes, print images, and filling patterns directly on the screen. Additionally, it offers highly detailed user access controls, efficient workflow capabilities with electronic signatures, and a comprehensive audit trail that complies with 21 CFR Part 11 regulations. The system also generates reports that provide in-depth packaging instructions along with a breakdown of material requirements, ensuring thorough documentation and compliance for trial processes. This multifaceted tool is essential for maintaining the integrity and organization of clinical trial packaging.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

LifeSphere CTMS Yes 
LifeSphere EDC Yes 
LifeSphere RIMS Yes 

Integrations

LifeSphere CTMS No 
LifeSphere EDC No 
LifeSphere RIMS No 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based No 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows Yes 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours No 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support No 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) No 
In Person No 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) No 
In Person Yes 

Vendor Details

Company Name

ArisGlobal

Founded

1987

Country

United States

Website

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

Vendor Details

Company Name

Fleximation

Founded

1994

Country

Switzerland

Website

www.fleximation.com/trialpack/designer/index.html

Product Features

Clinical Trial Management

21 CFR Part 11 Compliance No 
Document Management No 
Electronic Data Capture No 
Enrollment Management No 
HIPAA Compliant No 
Monitoring No 
Patient Database No 
Recruiting Management No 
Scheduling No 
Study Planning No 

Product Features

Clinical Trial Management

21 CFR Part 11 Compliance No 
Document Management No 
Electronic Data Capture No 
Enrollment Management No 
HIPAA Compliant No 
Monitoring No 
Patient Database No 
Recruiting Management No 
Scheduling No 
Study Planning No 

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