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features
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support

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Description

To meet ICH M7 guidelines, predict genotoxic and carcinogenic endpoints for impurities and degradations. Impurity profiling Suite is a tool that can be used in your ICH M7 workflow to help you prepare regulatory submissions and stay compliant.

Description

Preclinical information is found in many laboratories. It can be stored in multiple systems within the laboratory and with several external partners. Team members are unable to have clear and informed decisions without a unified solution because they lack transparency in core business data. Pristima, a fully integrated digital laboratory execution platform, features intelligent workflows, task automation, and data and information management throughout the entire preclinical process. Xybion's preclinical platform provides a central data repository as well as a standard archive platform. This platform can help you increase productivity and lower costs. With complete transparency across all platforms, gain visibility into the information that is there and take actions based on your current business needs. Effective data management can reduce the time it takes to submit final SENDs from end-of-study.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Savante No 

Integrations

Savante Yes 

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

Customer Support

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

Customer Support

Business Hours Yes 
Live Rep (24/7) Yes 
Online Support Yes 

Types of Training

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

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Vendor Details

Company Name

ACD/Labs

Founded

1994

Country

Canada

Website

www.acdlabs.com/products/percepta-platform/impurity-profiling-suite/

Vendor Details

Company Name

Xybion

Founded

1977

Country

United States

Website

www.xybion.com

Product Features

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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