DSG Helps Human Genome Achieve Phase III Success
8.17.09
Human Genome Sciences (HGS; Rockville, MD) credits EDC technology from DSG (Malvern, PA) for helping the company meet the primary endpoint in two Phase III trials of its Lupus drug BENLYSTA.
The study, BLISS-52, utilized DSG's eCaseLink EDC software to capture data and support data management in their Herculean task of monitoring the nearly 400 electronic case report forms per subject.
“This was our first experience with EDC, and DSG really helped lead the way," said Pierre Verroye, Executive Director of Clinical Data Management and Clinical Programming, HGS, in a company press release. "Sites and CRAs gave us a lot of positive feedback about the eCaseLink system.”
If BENLYSTA is approved, it will be the first drug approved in decades for people living with systemic lupus.
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.
