eClinical Software: February 2009

CTMS Addresses Small–Midsize Company Needs

Enhanced version is integrated with IVRS/IWRS and EDC

Perceptive Informatics (Boston, MA) announced it has enhanced TrialWorks 2.1, its clinical trial management system (CTMS), which includes updated reporting, data transfer, and analyzing capabilities. Version 2.1 is also aligned with new requirements for uploading information to ClinicalTrials.gov for registering clinical trials and can export files for import into the government-based Web site. Version 2.1 is aimed at the small to midsized company.

Perceptives enhanced TrialWorks 2.1

The TrialWorks solution also includes over 175 standard reports and new options to classify studies. It also features a Web interface for the Universal Data Transfer Tool, which can provide more streamlined transfer of patient and visit data when used with TrialWorks.

Perceptive Informatics, (866) 289-4464, www.perceptive.com

Web-Based Trial Report Distribution Released

Safety-to-investigator reporting automated

Aris Global (Stamford, CT) announced agXchangeSIR (safety-to-investigator reporting), a Web-based trial report distribution system that automates the distribution of clinical safety reports and other clinical documentation. The feature allows suspected unexpected serious adverse reactions (SUSARS) or aggregate line listings to investigators and other stakeholders based on a defined distribution list or to all studies associated with a product.

Aris Global Launches agXchangeSIR

Designed with the investigator in mind, an investigator portal allows investigators to select preferred method of receipt of the report and viewing of the report. After the report is viewed, an automated acknowledgement is sent to sponsors for tracking and generation of detailed history reports. Other modules of the agXchange gateway include electronic submission and inbound receipt triage.

Aris Global, (203) 588-3045, www.arisglobal.com

Web-Based Coding and Browsing Available

Designed for pharma and CROs to address adverse events

Praxis Life Sciences (Indianapolis, IN) announces its Semantix coder and browser for the medical dictionary for regulatory activities (MedDRA) is available through subscription over the Internet. Semantix was designed for pharmas and CROs to improve MedDRA browsing through improved search, clear display of term history, detailed information regarding term changes over time, and easy access to multiple versions of MedDRA. Semantix supports autocoding and quick import/export to spreadsheet files.

Praxis Web-based Coder and Browser

With the increased emphasis global regulatory agencies are placing on adverse event reporting, Semantix was designed to address the key challenges in accurately reporting medical events.

Praxis, (317) 275-2870, www.praxismi.com