Ipsen will be standardizing its content management on Veeva Systems' Veeva Vault
France-based specialty pharmaceutical company Ipsen will be standardizing its content management on Veeva Systems' Veeva Vault cloud-based platform. Ipsen is replacing a mix of customized solutions built on an outdated legacy platform with Veeva Systems’ suite of applications, spanning from clinical to commercial. The first application deployed was Vault Submissions, which will manage Ipsen’s regulatory submissions content across 20 countries. Ipsen will phase in Vault PromoMats, Vault eTMF, and Vault QualityDocs – business applications for promotional materials, clinical trial documents, and quality documentation management respectfully – to more than 3,000 internal users initially, and to hundreds of external partners.
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.
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
July 11th 2025The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.
QWINT-1 Trial: Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management
July 10th 2025Results from the Phase III QWINT-1 trial show that Eli Lilly’s once-weekly insulin efsitora is noninferior to once-daily glargine in reducing HbA1c among insulin-naïve adults with type 2 diabetes, offering a simplified fixed-dose regimen with fewer hypoglycemic events and less treatment burden.