Why implement CDISC standards?

Sponsors are receiving clinical information of increased complexity, from multiple sources and different formats. As a result, clinical data submission has become more time-consuming, costly and error-prone. To tackle this challenge, CDISC® (Clinical Data Interchange Standards Consortium) has been establishing new non proprietary clinical data standards to speed up data-review and improve clinical data exchange, storage and archival. Conforming to these recognized CDISC standards accelerates FDA submission and FDA review. 

 Download our brochureDownload our brochure to know more about all our CDISC services

CDISC Express service packages to accelerate your CDISC SDTM conversion 
 

Our new CDISC Express service package will streamline your clinical trial process. As leading experts in CDISC conversion, we leverage years of expertise and know-how to quickly and easily map your clinical data to CDISC SDTM.

Our service offer has been specifically packaged to fit the different needs of our customers. All our service packages come with full service CDISC help desk support.

 

 ​Base package                Pro Package                  Entreprise Package

By using our in-house free SAS-based mapping tool CDISC Express, our CDISC Express service packages defeats all prices on the market.

Contact us now to know more about our CDISC Express service packages

 

Efficient open source technology for faster CDISC conversion

CDISC® Express

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.

Main benefits

  • 4x Speed-up of CDISC SDTM conversion
  • Streamlined SDTM mapping
  • Code reusability for future clinical trials
  • Faster FDA regulatory review

 Download CDISC Express

The program is delivered with user-friendly navigation tools, an extensive documentation and a dedicated free support system to help you in your first use of CDISC Express. We also provide a monthly support to our customers. 

CDISC Service Packages
Different prices for different needs. Contact us now to learn more about it!
 
Webinar
Clinovo regularly organizes FREE webinars on CDISC SDTM conversion. Stay informed!
 
White Paper
Download our white paper on CDISC Express

CDISC Express has been successfully implemented for major biotechnology and pharmaceutical companies.

Stetson Line, Genentech

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   Read our case studies

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 Our CDISC services

Our experience in Clinical Data Management (CDM) and CDISC standards implementation facilitates clinical data conversion and timely deliverables.


Top-end services to help sponsors achieve faster SDTM mapping:

  • Full clinical study mapping
  • CDISC capability assessment
  • Implementation of client custom SDTM specifications 
  • CDISC conversion from any clinical database 
  • CDISC submission review 
  • CDISC training

Learn more about our CDM expertise

Our CDISC Express Monthly Support services

Clinovo delivers a full service CDISC help desk support that includes:

  • Application releases, including bug fixes and enhancements
  • Faster tracking of reported issues and/or enhancements
  • Application helpdesk, including 10 tickets per month to assist end-users faster
  • Discount for customizations and domains set up
  • Quarterly product steering teleconference to allow customers to influence the product roadmap
 

Contact our CDISC experts team to learn more.