Isis Pharma Utilizes Site Specific CRO for Study
The New England Journal of Medicine recently published results of a multi-center Phase II clinical trial, managed by CTMG.
The New England Journal of Medicine recently published results of a multi-center Phase II clinical trial, managed by CTMG-a site specific research organization (SSRO)--examining the safety and efficacy of Isis Pharmaceuticals' novel antisense drug, volanesorsen, in treating patients suffering from hypertriglyceridemia (severely elevated triglyceride levels). The study used CTMG’s protocol-specific processes, internal quality systems and proactive reaction time in identifying and eliminating barriers to continued patient participation, ensured all qualified patients were enrolled within nine months, with nearly all completing the year-long study, and providing high quality data for FDA review.
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.
