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.
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
June 27th 2025At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.