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.
Unlock Commercial Growth through Data-Driven Patient and HCP Insights
May 2nd 2025Leveraging data-driven patient and healthcare provider (HCP) insights, including social drivers of health (SDOH), is essential for life sciences companies to continuously improve patient engagement and commercial success. Mark Rodgers, AVP of Commercial Analytics at Inovalon, discusses how identifying treatment milestones, assessing HCP performance, and segmenting patient populations using SDOH data can drive targeted strategies that improve healthcare outcomes and market access
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis
April 30th 2025Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.
