CLINICAL TRIALS ARE research studies on human subjects that ultimately allow a drug to enter the
market. The ClinZen Clinical Trial Management System (CTMS) is a software system that coordinates
these complex trial processes and manages enterprise-level data.
A Texas-based biotech company, ClinZen LLC is ushering in the future by retooling the next-generation
clinical trial space. With a suite of products, it cuts the time and resource consumption to half or less,
typically impacting the business bottom line favorably. More importantly, the earlier availability of the
drug reduces suffering and pro- longs life. Saving lives is what ClinZen is about.
To improve collaboration among sponsors, physicians, participants and study coordinators, the
noncoercive use of mobile devices makes a huge impact - enabling everyone at all levels, bringing all
mobile devices under the same usability umbrella as desktops and laptops. ClinZen brings futuristic
recruitment strategies, for example, with Mobile Case Report Forms (mCRF), which relegates the
unnecessary disciplines required previously to a dark corner -no wires and less paperwork.
Mathematically optimized novel solutions for shared calendars, real-time data capture, configurable
dashboards, risk-based monitoring and do-it-yourself design of Case Report Forms bring significant cost
reductions to the user. Cognitive neuroscience drives the navigation and user interface design. ClinZen
brings a new creed of words to the table: innovate, engineer and think. No matter how well engineered
a product is, it must be functional and address the needs of the end user. That is ClinZen's thought
framework.
ClinZen's standards-based CDISC (Clinical Data Interchange Standards Consortium) adoption and
Event Driven Finite State Machine (eFSM) architecture add the much-needed enhancements over and
above the Gartner-predicted savings of 50 percent using CDISC alone. In a domain that needs it the
most -namely cancer - tumor identification, disease progression and drug response assessments are
managed with greater precision and speed. Most importantly, cloud-based scalability and ease of
integration tilt strongly in its favor. The product mitigates risks, compresses timelines and has no hidden
costs.
ClinZen is integrating social media with CTMS solutions, primarily in the area of electronic patientreported
outcomes (ePRO), disseminating guidelines and information centered on trial and disease
awareness. The incorporation of social media, the use of cloud services and the inclusion of mobile
apps will take the business enablers to more than $200 billion by 2015. The high adoption rate of mobile
products and the success of mHealth initiatives are additional catalysts.