Case Study | CDISC Express®
|
|
"It took about 3 months to develop CDISC mappings in an alternate application. A Clinovo programmer was able to achieve a similar result in under 2 weeks on average"
Stetson Line, Senior Manager of Clinical Programming
Background
One of the world’s leading biotechnology companies was looking for a way to efficiently convert their clinical data to CDISC global standards for their FDA submission.
They selected CDISC Express®, a SAS®-based CDISC® SDTM mapping tool that easily converts clinical data to CDISC standards. The ability to re-use the same code to produce study standard listings, edit checks and various reports was a clear benefit that would save both time and cost when converting their clinical data to the SDTM common format.
Challenge
The sponsor had no system in place or effective standard method to convert their clinical data to CDISC standards. The data conversion process to CDISC proved time-consuming and difficult to handle.
They were using ETL technologies, which proved challenging as ETL consultants do not have any experience with CDISC. Alternatively, their SAS programs became quickly unmanageable as all mapping had to be performed manually.
Solution
To help the sponsor convert their clinical data to CDISC standards in a fast, cost-effective way, Clinovo developed CDISC Express®, a SAS application that automatically converts clinical data into CDISC SDTM using an Excel framework.
Leveraging our strong SAS programming skills and extensive knowledge in CDISC standards, CDISC Express® was deployed in a very short timeframe and significantly facilitated the CDISC conversion process.
Significant Time Savings
CDISC Express® facilitates clinical data conversion and helps achieve timely deliverables:
- Automation of clinical data standardization
- Easy integration of clinical data from multiple sources
- A uniform format for easier view and management of clinical trial data
- User friendly navigation tools
- Code reusability for future trials
Our Key Differentiators
Knowledge of industry standards. Clinovo is a CDISC Gold Member. By joining the CDISC family, we strengthened our commitment to improve the clinical trial process and expand the adoption of CDISC standards.
Open source technology. To help the sponsor conduct faster, cost-effective clinical trials, we developed an innovative open source system to save costs while keeping high clinical data quality and security.
|
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.
|
|
