Technology Solutions – ZBI Innovation

ZBI focuses on defining, implementing and applying standards so our clients can focus on research, reporting and successful submission. We helped write the standards, and we’re continually active in revising and improving them. But there’s nothing standard about the way we approach solving problems for our clients. Look at these case studies to see ZBI innovation at work.

Case 1: Benchmark and Validate a Clinical Data Repository.
Our client requested complete clinical study data packages for several therapeutic indications and several complete clinical studies for each indication in order to benchmark and validate a clinical data repository.

The ZBI Solution:
Simulate the complete data packages using free, published clinical studies results. Leverage the data with proprietary ZBI Monte Carlo simulation technology backed by decades of accumulated ZBI experience in clinical studies design, data management and analysis. Result: complete clinical data packages that responded to the sensitive points of the clinical data repository design, with an added plus – the data had the look and feel of real-life patient data for physicians.

Case 2: Innovate Conservatively.
A client asked whether it would be possible to build a software tool that would enable them to incorporate pharmacogenomic data in the design of clinical studies.

A Novel ZBI Solution:
Of course it’s possible. And we did it. But we went beyond mere problem solving, with an approach that combined innovative thinking about clinical study design with a conservative approach to software development. Result: novel ZBI ideas enabled the incorporation of pharmacogenomics, speeding up clinical study execution … but our conservative approach used off-the-shelf software to power the software tool, helping the client speed-to-speed implementation.

Case 3: A Best-of-Both-Worlds Solution.
Our client asked for our help in streamlining FDA-regulated serious adverse event reporting using XML and SAS. ZBI was the ideal partner for this assignment. We led in the development of XML processing with SAS, and we continue to lead as a member of the CDISC Technical Committee, which wrote and maintains the CDISC XML standard for clinical trials data.

The ZBI Solution:
So we were able to bring together the best of both the XML and SAS worlds. Our solution exploited the application-to-application data transfer advantages of XML while avoiding its major disadvantage -- alien data structure. Result: an extension of SAS's XML capabilities, speeding and simplifying the reporting process.