From an interview with: DZS VP of Programming & Product Development , Bob Borysko
How and why was DZS Software Solutions founded?
My two partners, Doron Steger and David Horowitz, and I founded DZS in 1996. In 1992, I was working with a consulting group to develop a data management system for a Tier 1 Pharma company, and I retained the rights to that software. At the same time, Doron Steger's company developed a reporting solution for another Pharma for authoring statistical tables and data listings, and his company retained the rights to that as well.
We joined forces when I responded to an RFI for a data management system by Doron's company. We both saw the value and potential to market both SAS-based systems under one brand as did David who was providing strategic marketing and sales support for Doron's company, at that time. As a result, we decided to form DZS Software Solutions. Most of the popular data management systems then were Oracle-based. Our SAS-based system was easy-to-use and provided a flexible alternative to the more cumbersome Oracle-based systems. On the report side, our system provided powerful tools for programmers to easily produce complex statistical tables and listings in a validated environment.
What differentiates DZS products from other software solutions?
ClinPlus Data Management and ClinPlus Report are both written completely in SAS and help differentiate DZS by putting our systems in the hands of actual users rather than IT departments. The technology provides a great deal of flexibility, scalability and time savings. Typically, when you deliver a submission to the FDA, the data is always in SAS and the analysis is always done in SAS. Because our data management system is written in SAS and the database is in SAS, there is no conversion required as there is when taking data from an Oracle database. Analysis can be done immediately on the data as it is being entered, in real-time, saving countless hours of converting data from Oracle or other databases. That's really what differentiates DZS products from the competition. Our system design has always stressed flexibility and usability. All our programmers have either come from a CRO or Big Pharma environment and really understand what clients require and expect in a system. Since the software has been in use for many years in real-world trials, it is very stable, very intuitive and well supported. DZS is able to offer what is probably the best support model available in the form of developer-level support. When a client calls with a question or a problem, they're talking to one of the actual application developers, not just a help-desk person. I think that's why our customers stay with us. We've lost very few customers over the years. Most of the customers that we've lost have left because they went out of business, not because of dissatisfaction with DZS as a vendor.
Describe DZS Software's development roadmap?
On At DZS, we've expanded many of our software offerings.We've just released a new module for our ClinPlus Report software called the SDTM/ADaM conversion and reporting toolkit. This module supports the CDISC SDTM standard and takes that standard a step further by converting SDTM data to an analysis data model called ADaM for submitting analysis data and traceability metadata about how the data was derived or calculated to reviewers at the FDA. This new module includes an extensive template library of tables and listings that eliminates thousands of hours of custom programming when preparing safety and efficacy data. Additionally, DZS offers complete tables, listing and graph programming support. While our report system traditionally supported biostatisticians and the statistical programmers' requirements to produce tables and listings, DZS is now offering what we call a ‘lite' version of ClinPlus Report to appeal to the data management group. This version includes the ability to produce patient profile listings and custom listings with random selection of data, extremely valuable when source data goes through final QC. Our new version of our ClinPlus Coding software is probably the first coding software to support the WHODrug Enhanced Dictionary that's just now starting to gain popularity.
We recently released a brand new web-based CTMS (clinical trial management system) system, and we'll also have a more enhanced EDC system in early 2010. Our current data management system is SAS-based, but this new EDC system will be a more traditional EDC system, completely web-based and built on a .NET architecture.
What future challenges does DZS face?
On the development side, a major challenge has been trying to keep up with the ever-changing regulations and standards like CDISC, HL7, eCTD, RPS, CFR21 Part 11, and so on. Another is adapting to emerging technologies. Traditionally, DZS was exclusively SAS-based, but we are now offering other software architectures that provide distinct advantages to delivering software and collaboration using the Internet.
On the marketing side, increasing brand and product awareness is our main challenge. In the past 10 or 15 years, there's been a huge shift in the way software is procured and implemented within an organization. In the past, clients would review vendors and software by attending industry tradeshows and conducting on-site demos.
These days, almost everybody uses the Internet to determine potential technology solutions. Accordingly, DZS is redefining our marketing spend to utilize the Internet for branding and delivering marketing campaigns that explain the value of our software and services. We're committed to making the ClinPlus web site an inviting resource for customers and prospects to visit, improving our search engine optimization and providing the most current information on industry trends and challenges and how our products and services add value for clients in meeting these challenges.
What changes have DZS observed in the industry?
One of the most significant changes in this industry has been the continued movement toward electronic data capture (EDC). Roughly 10 years ago, we started hearing about EDC and predictions that, within five years, paper would disappear. Today of course, that hasn't really happened. There are still many studies being done in paper and although the hype has died slightly, people are still looking steadily toward EDC as a solution. Our SAS-based software has kept up with that with the addition of capabilities that allow the software to function as an EDC system. Since the system was born out of a paper-based system, it lends itself perfectly to being used as a hybrid system. Many of our clients actually require this. Of late, we've seen many studies where some sites use our EDC system, yet other sites that are unable or unwilling to implement EDC are sending traditional case report forms (CRFs) that are double- key entered straight into the same system. Another significant change is the emergence and continued acceptance of electronic submissions. About 10 years ago, DZS was doing CANDAS- Computer-Aided NDAs-where we would develop software and pretty much deliver a computer to the FDA with software to help them review the data. That's completely changed now with more and more submissions being done electronically and across multiple global regions utilizing eCTD and CDISC SDTM standards. That's a significant and technologically challenging change, but one that DZS is prepared to respond to.
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