Oracle Announces the Release of Oracle Argus Safety Suite 5.1
Oracle (Redwood Shores, CA) announced the release of Oracle Argus Safety Suite 5.1, its integrated pharmacovigilance suite that helps users meet regulatory compliance by supporting drug safety processes across the R&D spectrum, from clinical development through post-marketing.
The new release includes enhancements to Oracle Argus Safety (advanced reporting features, including dashboards and metrics, and new automation functionality for case processing), Oracle Argus Insight, and Oracle Argus Perceptive.
“Health sciences organizations recognize that they can significantly reduce the costs and risks associated with bringing drugs and devices to market by identifying and effectively managing safety issues early,” said Neil de Crescenzo, Senior Vice President and General Manager, Oracle Health Sciences. “The Oracle Argus Safety Suite has proven effective in helping organizations of all sizes ensure regulatory compliance and improve the overall safety of therapies.”
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.
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.
FDA Grants Ziftomenib with Breakthrough Therapy Designation for NPM1-Mutant Acute Myeloid Leukemia
April 23rd 2024Data from the Phase Ib portion of the KOMET-001 trial showed that the once-daily oral treatment may provide a substantial improvement over available therapies for relapsed/refractory NPM1-mutant acute myeloid leukemia.
