CluePoints Launches Risk-Based Monitoring Starter Pack
CluePoints has launched the “CluePoints RBM and ICH E6 (R2) Starter Pack” to help small and medium-sized enterprises achieve regulatory compliance through a “risk-based” approach. This starter pack helps to address the problem of embracing RBM through the use of consultation on the ICH E6 addendum and RBM methodology. This will further help organizations understand the regulation and aims to improve costs and resources all while providing them with the necessary tools.
Read the full release here.
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.
CAHtalyst Trial Shows Crenessity Sustains Efficacy in Classic Congenital Adrenal Hyperplasia
July 14th 2025Results from the Phase III CAHtalyst show that patients treated with Crenessity for classic congenital adrenal hyperplasia achieved and maintained lower, more physiologic glucocorticoid doses while keeping key adrenal biomarkers at or below baseline levels.
Baxdrostat Shows Significant Blood Pressure Reduction in Phase III BaxHTN Trial
July 14th 2025In the BaxHTN Phase III study, AstraZeneca’s baxdrostat demonstrated statistically significant and clinically meaningful reductions in systolic blood pressure in patients with uncontrolled or treatment-resistant hypertension.
