The Next Clinical Trial Tool Set

By: Suvro Ghosh
Tuesday, June 3, 2014

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 prolongs 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 patient-reported 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.

ClinZen’s CTMS, in summary, aims to fill in the gaps in existing systems, address the unmet user needs and supplant the ancient units unable to accommodate. The customer pie is in three segments: pharma companies with 49 percent, clinical research organizations with 46 percent and healthcare providers with 5 percent. The eClinical sector, slated to hit the $4.8 billion mark by 2017, is a major and growing component of the $40 billion Health IT Care Funds group. ClinZen has nowhere to go but up.


Suvro Ghosh

Contact Suvro Ghosh, Founder and CEO, at suvro.ghosh@clinzen.com 
or 210-858-7978. Learn more at www.clinzen.com.