Calyx, the eClinical and Regulatory solutions and services provider, has announced that one of the world’s Top 10 pharmaceutical companies executed a contract to continue its use of the Calyx Regulatory Information Management (RIM) system for critical submissions of clinical development data to global regulators through 2026. Calyx RIM enables pharmaceutical companies to compile and submit comprehensive dossiers to global regulatory authorities.
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.
Gilead Shares Final Data from Phase III MYR301 Trial of Bulevirtide in Chronic Hepatitis Delta Virus
May 7th 2025Long-term results from the study show 90% of patients with chronic HDV who achieved undetectable HDV RNA at 96 weeks of treatment remained undetectable for nearly 2 years post-treatment.