CDISC Mapping

 

Clinovo CDISC Services to accelerate your FDA review

Accelerate your FDA review. Clinical information tends to be more complex, comes from multiple sources in different formats. As a result, clinical data submission has become time-consuming, costly and error-prone. CDISC® (Clinical Data Interchange Standards Consortium) established new data standards to speed up data-review and improve clinical data exchange, storage and archival. Our technology edge combined to our experience in standards implementation allows us to develop tailored CDISC solutions to accelerate your FDA review.

CDISC Gold Member and Registered Solutions Provider

CDISC Express is a powerful open source SAS®-based clinical data management system that automatically converts clinical data into CDISC SDTM using an Excel framework. CDISC Express includes the automatic creation of Define.XML, a generic SDTM validation tool as well as lab standard units and toxicity. CDISC Express significantly speeds-up CDISC SDTM conversion, thus resulting in faster FDA review.
 

Watch our on demand webinar now!

Streamlined CDISC Conversion and Reporting

by Ale Gicqueau, President & CEO at Clinovo, CDISC Official Trainer   
and Rick Morrison, CEO at Comprehend Systems

Streamlined CDISC Conversion and Reporting  by Ale Gicqueau President & CEO at Clinovo and Rick Morrison CEO at Comprehend Systems

Streamlined CDISC Conversion and Reporting  by Ale Gicqueau President & CEO at Clinovo and Rick Morrison CEO at Comprehend Systems

Features

  • SAS-based and Define.XML
  • Excel based mapping definitions
  • Global SDTM definitions
  • Extensible function library
  • Web interface

Benefits

  • Easy integration
  • Portability
  • 4x Speed-up of CDISC conversion
  • Reusable macros
  • Flexible and user friendly
Download CDISC Express now

 Download our brochure Read our brochure or contact our team to learn more about CDISC Express

 


 


 

CDISC Services

 

Clinovo's CDISC mapping Services Base Package Clinovo's CDISC mapping Services Pro Package Clinovo's CDISC mapping Services Entreprise Package

Mapping

Up to 4 domains
Up to 12 domains
Up to 20 domains

Support & updates

     

First use support

Online helpdesk system

10 tickets
(valid for one year)
20 tickets
(valid for one year)
50 tickets
(valid for one year)

Documentation

Application releases

Training

Free webinars 2 hour base training 1-day advanced training

21 CFR Part 11 compliance

Discounted price for system validation
Discounted price for system validation

CDISC Express validation kit

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