eShowcase: Oracle Initiatives Focus on Drug Safety
Recent announcements streamline adverse event reporting
Recent announcements streamline adverse event reporting
Oracle (Redwood Shores, CA) announced Safety in a Capsule, an IT and service collaboration between Oracle, Tata Consultancy Services (TCS), and DrugLogic. The offering combines Oracle's Siebel Contact Center Integration Pack for Oracle's Adverse Event Reporting (AER) System, DrugLogic's signal detection solution QScan, and TCS' Knowledge Process Outsourcing services to monitor and analyze pre- and postmarketing AER data for increased drug safety.
The Siebel Contact Center Integration Pack for the Oracle AER passes customer, product complaint, and potential AER information from the contact center to automatically load event-related information into the Oracle AER system. This solution works to reduce duplicate data entry, conflict resolution, and reconciliation. It is part of the Oracle Application Integration Architecture.
Oracle, (800) 672-2531, www.oracle.com
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Oveporexton Shows Superior Efficacy in Phase II Narcolepsy Type 1 Trial Without Hepatotoxicity
May 16th 2025In the TAK-861-2001 Phase IIb study, oveporexton significantly improved wakefulness, daytime sleepiness, and cataplexy frequency in patients with narcolepsy type 1, outperforming current therapies and avoiding liver toxicity seen with earlier OX2R agonists, according to results published in The New England Journal of Medicine.
