FDA approves Nanocoated Coronary
Stent System using DSG’s eClinical Systems.
MALVERN, Pa., March 23, 2017, CeloNova Biosciences, Inc. leveraging products and services provided by DSG Inc., a leading eClinical software technology and data management global services firm, has recently received US Food and Drug Administration (FDA) approval of its first-in-class COBRA PzF ™ NanoCoated Coronary Stent System.
DSG’s eCaseLink EDC allowed CeloNova Biosciences to manage subject enrollment and capture data efficiently in the global clinical trial of the COBRA PzF Coronary Stent. DSG handled all aspects of clinical study data management from database setup through lock.
DSG's data management team added value to their eCaseLink EDC solution by providing CeloNova Biosciences with clean, timely, and cost-effective deliverables and week-to-week metrics showing their own progress throughout the lifespan of the study,” said Mark Barakat, MD, Senior Director, Medical Affairs at CeloNova.