Forte Research Systems, Inc.
, a developer of clinical trial management systems (
CTMS
), and
Virtify, Inc.
, a provider of structured content management software solutions for life sciences, announced today a partnership that aims to simplify compliance with disclosure requirements of the Food and Drug Administration Amendments Act (FDAAA). The agreement addresses the increasingly stringent regulations imposed on clinical research institutions.
The integration will take place between Forte's OnCore® system, an enterprise-class
clinical research management system
utilized by academic medical centers and cancer centers, and the
Virtify CTRR
(Clinical Trial Registration & Results) software, which streamlines and automates the mandatory disclosure postings to the ClinicalTrials.gov online registry and results database.
"Collaborating with Virtify allows us to provide a seamless and sophisticated experience for OnCore users as they comply with these regulations," said Srini Kalluri, Founder, CEO, and Chief Customer Officer at Forte. "OnCore is a proven system that supports streamlined management of robust portfolios of clinical trials. Coupled with the many benefits of the Virtify CTRR, OnCore becomes the most comprehensive solution available for compliance with clinical trial disclosure requirements."
Among the benefits offered by Virtify CTRR is an easy-to-use centralized compliance monitoring system for clinical trials. It offers the status of all trial disclosures and helps users proactively identify their risks related to trial disclosure and non-compliances.
When integrated with the OnCore system, the Virtify solution will provide an end-to-end disclosure solution. "It will extend CTRR's robust disclosure process management features to the OnCore system, which in turn will be able to share data directly with Virtify CTRR," said Satish Tadikonda, CEO of Virtify. "The ability of the systems to communicate means that duplicate data entry will be eliminated."
The new agreement is the most recent among several collaborations in which Forte has joined with industry leaders to provide comprehensive solutions and eliminate data silos. "With Virtify's extensive experience and expertise in the clinical trial disclosure arena, it makes perfect sense to partner with them rather than reinventing the wheel," Kalluri said. "This will continue to be our strategy in order to bring greater efficiencies to the industry."
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.
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.