SPIRA

THE SPONSOR

� One of the pioneers of the

biotech industry

� Over 13,000 employees

� $11.7B in annual revenue

� 20 different studies

� Multiple therapeutic areas

� Phase I study

STUDY AT A GLANCE

x4 Speed-up of CDISC

conversion

Client Success Story

CDISC Mapping Tool for Efficient CDISC® SDTM Implementation

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.

The 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.

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.

Local. Our local mid-sized structure enables responsive communication to stay on top of

our client’s needs.

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 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.

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

� Streamlined data mapping

� Efficient conversion to SDTM

� Faster FDA regulatory review

� Download for free:

www.clinovo.com/cdisc

CDISC EXPRESS® BENEFITS