CR Toolkit™ SAS Macro Library Enables Your Organization to Expertly Work with Study Reports, Consistently and Accurately Every Time

 

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SAS Macro Library

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Standard Call Interface

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Fully Documented Validation Package & User Manual

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Training

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Ongoing Support

The toolkit is compatible with SDTM and ADaM data standards.

  • Define-XML
  • Analysis Data Reviewer’s Guide (ADRG)
  • Study Data Reviews Guide (SDRG)
  • CDISC SEND, SDTM, and ADaM
  • Reduce lines of code & development time by over 50%
  • Reduce variability by standardizing statistical operations
  • Enables consistency throughout your programming environment
  • Streamlines QC process
  • Adds validation
The CR Toolkit™ took our Tables, Listings, and Graphs from taking 3-4 months down to 2-3 weeks.
— Pharmaceutical Company Client
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Easy to modify for execution with systems such as EntimICE, and fully compatible with PhUSE and CDISC initiatives.

 
 

Why CR Toolkit™?

We believe that data transformed properly into drug information is at the heart of every FDA approved, life-saving drug... and organized, efficient, accurate data enables those life-saving drugs to get approval and reach patients faster.

The CR Toolkit™ SAS macro library facilitates preparation of reports conforming to sponsors’ standards. It enables you to assemble and produce consistent reports. You can work with any data structure and content, and it supports CDISC standards (ADaM and SDTM).

Over multiple studies and the long path to submission, many things can change including protocols, personnel, and reporting requirements. These changes will affect your data, and in turn, the information for your submission - reports.

The Risk: Reports in various formats generated from data stored on local computers, on-premises servers, databases, off-site servers, and in the cloud, must be brought together for analysis.

The Challenge: Reports are processed using code and non standardized formats from multiple sources written by different programmers/vendors with varying skill levels and standards.

The Solution: CR Toolkit™ reduces programmer variability, drives overall standardization, and reduces programming and validation efforts.

 

Manual Reporting vs. SAS Macro Library (CR Toolkit™)

 

Non-Standardized Code

When code is developed over time by multiple programmers with varying skill levels, standardization becomes difficult.

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Standardization

SAS Macros that have been tested by experienced programmers are used with datasets organized in standard formats.

 

QC Issues

Teams are presented with quality control challenges due to tables, listings, and graphs generated using non-standard code.

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QC System

Quality control becomes a clear process that enables efficient review and management of tables, listings, and graphs output by the SAS macro library.

 

Variability

Variability is introduced as a result of non-standard code being used by multiple programmers on data in different formats without a unified QC process.

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Consistency

Standardized code and a consistent QC process create macro outputs with higher quality and fewer errors.

 

Validation Inconsistency

The combination of these issues causes inconsistency in validation of outputs and can put deliverables at risk.

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Reliable Validation

The combined result of macro standardization and process control is simplified, reliable validation process that ensures your deliverables are correct and  ready for submission.