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Sunday, 27 August 2017

Pinnacle validator software features

 

Feature

Community

Enterprise

On-Demand

Data validation feature

 

Validate SDTM, SEND, ADaM and define.xml

X

X

X

Metadata driven and configurable

X

X

X

Data composition and quality reports

 

X

X

FDA data fitness assessment scorecards

 

X

X

Manage issues throughout the study lifecycle

 

X

X

Communicate and collaborate with partners

 

X

X

Monitor data quality improvement over time

 

X

X

Track changes across validation

 

X

X

Customize specs for SDTM+ or sponsor formats

 

X

 

Design rules for projects, studies and partners

 

X

 

Define.xml features

 

Create Define.xml 2.0 for SDTM, SEND and AdaM

X

X

X

Convert Define.xml 1.0 files into Define.xml 2.0

X

X

X

Extract metadata from SAS datasets

X

X

X

Extract origin page numbers from annotated CRFs

 

X

X

Merge metadata from external specifications

 

X

X

Generate Define.pdf

 

X

X

Validate Define.xml content in real time

 

X

X

Compare content with standards and other studies

 

X

X

Track changes between versions

 

X

X

Other features

 

Deployment options

Desktop

Web Hosted

Web Multi-tenant

Automated software and rules updates

X

X

X

Central configuration and management

 

X

X

Sandbox environment for training and testing

 

X

 

Increased scalability

 

X

 

Software licenses

Open Source

Subscription

Subscription

Quality, Compliance and Support

 

Community support forum

X

X

X

Professional email and telephone support

 

X

X

Rigorous QA, performance and scalability testing

 

X

X

GxP and 21 CFR Part 11 compliant

 

X

X

Service level agreement

 

Customizable

Standard

 

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