New Software to Improve Clinical Trial Performance

TranSenda International, LLC announced today that it is developing a new solution, Cortex, designed to improve an organization’s ability to manage a clinical trial’s performance. Based upon patent-pending ClinBUS® data interchange technology already in use in TranSenda’s Office-Smart solutions, Cortex will enable organizations to leverage the power of access to centralized operational data from all applications used across all clinical studies. For years the industry has struggled with an increasingly fragmented environment of disconnected clinical applications, sites and partners. TranSenda’s Cortex, with its proven ClinBUS technology, represents a breakthrough in managing and controlling studies within a common environment—independent of study data formats and clinical trial applications.

With the Cortex clinical trial management performance system, sponsors and Clinical Research Organizations (CROs) will benefit from real-time connectivity across complex partner networks and enterprise environments, delivering superior performance visibility for improved decision support and trial management. With this data now centralized, analysis is greatly enhanced because ClinBUS technology is optimized to make data available in Microsoft® Office SharePoint Server (MOSS). Previously hard-to-get-to operational data can now be easily controlled, communicated and coordinated between people and applications using MOSS.

Current industry practice relies on costly custom data connections between applications which are specific to each trial. By connecting all applications and all trials in a single information system, Cortex creates more efficient, cost-effective and sustainable access to important operational data. Cortex accomplishes this by standardizing the exchange of clinical trial management data and its semantics in a centralized server. Standardizing common operational data also facilitates interoperability between various clinical trial applications, including legacy Clinical Trial Management Systems (CTMS). Using ClinBUS data interchange technology, Cortex is also compatible with CDISC ODM data types.

Cortex is also designed to facilitate codeless customization by users with SharePoint® experience and by Microsoft Independent Software Vendors (ISVs). This feature enables the extension and customization of clinical processes at a fraction of the cost and time of conventional development environments. Cortex basically unleashes access to operational information across applications and trials and allows it to be used in Microsoft’s powerful Office System for the creation of configurable dashboards, specialized reports, custom workflow and much more.

Not only does Cortex unleash operational information to allow organizations to transform it into valuable knowledge, Cortex also enables a new level of “centralized” study management. For example, imagine being able to create custom workflow that generates user alerts based upon any combination of changes in data from interconnected systems. This would greatly improve a sponsor’s ability to respond quickly to prevent delays, unnecessary spending or regulatory non-compliance. An example of a centralized application that can take advantage of the Cortex environment is TranSenda’s Office-Smart Clinical Payment Manager. Site payment information that works on operational data maintained in ClinBUS from diverse CTMS and EDC systems could be managed centrally, helping ensure bottom-line study cost accuracy and meeting upcoming regulatory requirements for disclosure of items of value to healthcare professionals. Site payment and alert management are just two of many centralized solutions that Cortex can support to help fine tune an organization’s ability to effectively manage trials.

“Cortex is a unique solution that will address the challenges faced by clinical business partners who are trying to increase efficiency while working within an increasingly complex environment of geographical dispersion and disconnected software,” said Robert Webber, TranSenda’s President and CEO. “Working closely with Microsoft on our ClinBUS technology has given TranSenda the very latest software capabilities to uniquely address these challenges.” Value-added SharePoint web parts to assist with reporting study enrollment, subject completion, Case Report Form (CRF) progress, and clinical site payment tracking are also planned for the upcoming release. Commercial availability will be announced at a later date.