Chiltern Selected as Partner CRO
Chiltern announces it was selected as the partner CRO for Karolinska Development
Chiltern announces it was selected as the partner CRO for Karolinska Development, a publicly-traded life sciences investment company that brings selects and develops the most commercially attractive medical innovations to the point of sales or out-licensing to other companies. The extensive CRO selection process began in 2012 and the company states it was selected based on its compatibility with Karolinska's needs for global infrastructure, and approach to deliver on innovation, quality and flexibility.
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 Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
