COTA Launches New Services in Data Management
COTA is launching new services aimed at supporting life sciences companies with drug submissions to FDA and EMA. These new services include integrating RWD in research and development/
COTA is also now integrating emerging types of data in their platform, including clinicogenomics, social determinants of health, and sexual orientation and gender identity (SOGI). The company also recently launched their Vantage product, which gives subscribers real-time access to datasets that are refreshed with new data elements and records.
Read more about these new services 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.
