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
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.
New Data Emerges from Phase IIb RELIEVE UCCD Study in Ulcerative Colitis and Crohn’s Disease
February 25th 2025Following initial positive results shared by Teva and Sanofi in December 2024, new data shows duvakitug (TEV’574/SAR447189) achieved higher rates of clinical remission compared to placebo in the advanced therapy-experienced subgroup.
