CTMS Addresses Small–Midsize Company Needs
Enhanced version is integrated with IVRS/IWRS and EDC
Perceptives enhanced TrialWorks 2.1
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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.
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, http://www.perceptive.com/
Web-Based Trial Report Distribution Released
Safety-to-investigator reporting automated
Aris Global Launches agXchangeSIR
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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.
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, http://www.arisglobal.com/
Web-Based Coding and Browsing Available
Designed for pharma and CROs to address adverse events
Praxis Web-based Coder and Browser
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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.
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, http://www.praxismi.com/
