PHT Provides App of FDA Roadmap for COA Measurements
PHT Corporation is offering an app based on the FDA's Clinical Outcome Assessment Qualification Program
PHT Corporation is offering an app based on the FDA's Clinical Outcome Assessment Qualification Program. The FDA Roadmap App from PHT provides sponsors with the mobile capability on Android phones and tablets that optimizes the FDA-based website information. The FDA's Roadmap to Patient-Focused Outcomes Measurement in Clinical Trials highlights the process by which a sponsor should consider, choose and/or develop a patient-focused outcome measurement strategy in a clinical program.
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.
FDA Expands Farapulse PFA Approval to Persistent AF After Strong ADVANTAGE AF Trial Results
July 7th 2025Boston Scientific’s Farapulse Pulsed Field Ablation System is now approved for treating persistent atrial fibrillation, following 12-month data from the ADVANTAGE AF trial showing strong safety, high freedom from AF, and no major complications.
