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 CTMS was engineered using over 25 years of Clinical experience with particular attention paid to “best practices” in designing the wed-based user interface. This is extremely important in a system with a large user base as many complex CTMS systems are underutilized simply because they are confusing and cumbersome to navigate. We are often praised on how “clean” our system looks and how easy it is to learn. Our developers have done an amazing job of providing a feature-rich system while letting the users avoid the complexities.
ClinPlus Coding is the best Adverse Event and Coding product on the market today. It has the ability to code data directly in SAS, SQL Server and Oracle data sources, minimizing integration with EDC and Safety systems.
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?
At DZS, we've expanded many of our software offerings.
Our newest version of ClinPlus CTMS (clinical trial management system) incorporates several enhancements, two of which are extremely important: 1) The ability to tailor the system by adding custom fields to most modules. Custom fields are treated exactly like standard fields in that they can be included in custom reports (display, grouping, sorting, etc.) and are tracked in the system audit trail. Every organization has unique requirements; this feature allows them to easily address these without compromise. 2) Integration with Microsoft SharePoint allowing companies to directly access document stored in SharePoint.
Our new version of our ClinPlus Coding software was engineered specifically for the WHO Drug Enhanced Dictionary that's rapidly gain popularity. In fact, ClinPlus Coding has recently achieved Certification from the Uppsala Monitoring Centre (WHO Drug provider). Because of the advanced features of this system and its ease of use, ClinPlus Coding is quickly becoming an industry standard in Adverse Event and Drug Coding.
We have updated the SDTM/ADaM conversion and reporting toolkit to keep pace with current requirements. This toolkit supports the conversion of CDISC SDTM data to CDISC ADaM and creating metadata and a trace matrix back to the SAP. An extensive safety tables and listings template library is also included that uses the ADaM data structures as input.
Our ClinPlus 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.
A new version of ClinPlus Data Management will include over 25 enhancements representing our commitment to our customers needs. One of the most significant is the addition of a Dashboard that will provide drilldown access to all critical data in a single location. Other enhancements include improved query management workflow, one click export to CSV for all clinical and system data and improved performance.libraries.
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.