eClinical Software: February 2009
Applied Clinical Trials
The latest eclinical software in the clinical trials industry.
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
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Using Patient Reported Outcomes in Dermatology Trials
April 25th 2024In part 3 of this video interview with ACT editor Andy Studna, Melissa Mooney, director, eCOA sales engineering, IQVIA sheds light on the unique challenges of dermatology trials and how clinical outcome assessments can be implemented in them.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
