ICON announced ICONIK, an integrated technology solution that provides a single view of study information to both sponsor and CRO teams anytime, anywhere.
ICONIK provides immediate knowledge to study teams by allowing near real-time access to study performance metrics, critical safety and efficacy data, and analysis of this data in new and unique ways. ICONIK consolidates and standardizes data from multiple sources, including CTMS, EDC, IVR and ePRO, and combines the data with analytical, reporting and visualization tools to provide a singe view of study information. Both CRO and sponsor teams can easily access study information and trends anytime, anywhere from a secure, web-based interface. A 21CFR compliant solution, ICONIK enables sponsors to more easily meet regulatory requirements by providing an online, end-to-end audit trail of study data for FDA submissions and post-submission queries.
ICON has fully deployed the Oracle Life Sciences Data Hub, which will form the backbone of the ICONIK Clinical Data Repository. Oracle Life Sciences Data Hub is a validated and secure repository that pools clinical and non-clinical data from multiple sources into a single environment where it can be analyzed and reported to support better decision-making.
Moderna’s mRNA-1010 Flu Vaccine Meets Efficacy Goals in Phase III Trial of Adults 50+
July 10th 2025In the P304 Phase III study, Moderna’s mRNA-1010 demonstrated a 26.6% relative efficacy over a standard-dose flu vaccine in adults aged 50+, showing consistent protection across strains and age groups.
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.
QWINT-1 Trial: Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management
July 10th 2025Results from the Phase III QWINT-1 trial show that Eli Lilly’s once-weekly insulin efsitora is noninferior to once-daily glargine in reducing HbA1c among insulin-naïve adults with type 2 diabetes, offering a simplified fixed-dose regimen with fewer hypoglycemic events and less treatment burden.