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What is Trialpack Designer II?

The Trialpack Designer is an intuitive yet powerful software application tailored for the creation of blister packs and cards intended for clinical trials. It is particularly adept at designing packaging for complex blinded studies, such as those involving dosage titrations, double-dummy configurations, and cross-over trials, where a single package might include multiple items. The application effortlessly supplies essential configuration data for the Trialpack PC Controller, Controlled Dosing Systems, and Robotic Packaging Systems. Users can conveniently create various blister shapes, print images, and filling patterns directly from the interface. Moreover, it incorporates detailed user access controls, streamlines workflows with electronic signatures, and maintains a thorough audit trail in adherence to 21 CFR Part 11 regulations. The system also produces reports that offer comprehensive packaging instructions alongside a detailed inventory of material needs, which ensures meticulous documentation and compliance for trial activities. This versatile tool plays a vital role in preserving the integrity and organization of clinical trial packaging, ultimately contributing to the success of the trials conducted. Furthermore, its user-friendly design makes it accessible for professionals at all levels, enhancing collaboration and efficiency throughout the research process.

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

Fleximation

Date Founded

1994

Company Location

Switzerland

Company Website

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

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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