eClinical Software: September 2009

Patient Enrollment Software Updated

TCN 5.0 expands metrics and risk mitigation for key areas

BBK Worldwide (Newton, MA) announces TrialCentralNet (TCN) 5.0, its patient recruitment management system for sites and sponsors. TCN 5.0 features a robust communications infrastructure, tools for proactive planning of enrollment efforts, targeted site selection criteria, a recruitment development and implementation process, efficiencies for patient enrollment, and instant reporting on randomization and retention metrics.

In addition, TCN 5.0 features improved graphical interfaces for study site personnel and improved function across multiple browser platforms. The new version can be integrated with other clinical data systems as well as other TCN eSystems related to patient recruitment.

BBK Worldwide, (617) 630-4477, www.bbkworldwide.com

Protocol Manager 8.0 Delivers Web Availability

CRAs' needs also addressed in upgraded version of software

Winchester Business Systems (Woburn, MA) announced its Protocol Manager Version 8.0 CTMS, which now features Web-enabled access to authorized users worldwide. Also, a new Clinical Study Portal designed for CRAs joins the already existing portal for investigators.

Winchester CTMS developers have retained the IBM Lotus Domino platform, citing its broad offerings for workflow and application security. In addition, it eliminates the need to obtain separate components to serve as database manager, collaboration manager, email router, security system or Web server.

Winchester customers can purchase or upgrade to Version 8.0 CTMS by Enterprise Adoption, a traditional licensing model, or choose the optional hosting pricing model, featuring Software as a Service and paying on a trial-by-trial basis.

Winchester Business Systems, (781) 203-0200, www.wbsnet.com

Oversight of Global Clinical Trials

Clinical Quality Management Solution addresses process and compliance

Sparta Systems (Holmdel, NJ) announced TrackWise Clinical Quality Management Solution to provide end-to-end streamlining of clinical trial processes and ensure compliance with global regulatory standards. This extension of the TrackWise enterprise quality management system (EQMS) begins with preclinical activities through manufacturing and postmarket operations.

TrackWise Clinical Trial Quality Management Solution provides closed-loop process support to allow issues to be reconciled and corrected before they escalate. The solution manages incidents, structured audit programs specifically tailored around clinical trial execution, the associated CAPA and change control processes, as well as trial registration and trial documentation/SOPs.

Sparta Systems, (888) 261-5948, http://www.spartasystems.com