CluePoints Introduces RBM Software for Operational Data Analysis
CluePoints, a provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, introduced software to enable analyses of operational data using a risk-based monitoring approach.
CluePoints, a provider of Centralized Statistical Monitoring (CSM) solutions for clinical trials, introduced software to enable analyses of operational data using a risk-based monitoring approach. The new software includes Key Risk Indicators (KRIs) that complement the statistical analysis of clinical data. This KRI+ approach allows sponsors and CROs to set their own subjective threshold levels, while also statistically examining data objectively to show how a single site's KRIs can be judged against results across all other sites.
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.
