Metric Applied in Alternative iCardiac Safety Assessment Method
iCardiac Technologies announced the implementation of its quality metric--Method Bias Sensitivity (MBS)--into its Phase I QT assessment services. The metric compares the automated measurements from a timepoint to the measurements/values derived by that core lab’s methodology that was used for that particular study. Other metrics are under discussion by the Cardiac Safety Research Consortium members, however, iCardiac is implementing its metric after the ICH E14 http://www.appliedclinicaltrialsonline.com/alternative-path-tqt-studies approved a lower-cost approach to TQT studies for cardiac safety assessment.
Read the full release here
Unlock Commercial Growth through Data-Driven Patient and HCP Insights
May 2nd 2025Leveraging data-driven patient and healthcare provider (HCP) insights, including social drivers of health (SDOH), is essential for life sciences companies to continuously improve patient engagement and commercial success. Mark Rodgers, AVP of Commercial Analytics at Inovalon, discusses how identifying treatment milestones, assessing HCP performance, and segmenting patient populations using SDOH data can drive targeted strategies that improve healthcare outcomes and market access
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis
April 30th 2025Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.
