Certara Launches Cardiac Safety Simulator V2.0
Certara®, a global biosimulation technology-enabled consultancy, announced version 2.0 of its Cardiac Safety Simulator (CSS), which has become a standalone product for the first time. CSS is an alternative to Thorough QT/QTc (TQT) studies.
Certara®, a global biosimulation technology-enabled consultancy, announced version 2.0 of its Cardiac Safety Simulator (CSS), which has become a standalone product for the first time. CSS is an alternative to Thorough QT/QTc (TQT) studies. CSS uses drug-triggered cardiac ion-current disruption data, together with predicted in-vivo exposure information to evaluate the factors influencing potential cardiac risk.
CSS v2.0 offers new features including the following:
- Enhanced QSAR models for predicting drug-triggered IKr, IKs, INa and ICaL current inhibition based on automatically-calculated phys-chem data (when in-vitro data are not available)
- Predicts population variability and drug-triggered physiology modifications
- Permits assessment of the potential impact of disease and genotypes; allows for genotype-related ionic current modification at the multiple channels level
- Contains an additional human left ventricular muscle cell model
- Evaluates up to seven chemical species (drugs, metabolites and other substances) simultaneously that are interacting at the ion channel(s) level
- Provides a new flexible, Excel-based tool to enhancevisualization and analysis of simulation results
Realtime Electronic Data Capture at Investigator Sites: Laboratory Data and Beyond
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.
