Wednesday, January 30, 2019
The WIRB-Copernicus Group®'s (WCG™) Clinical Services Division has partnered with Prudentia Group, a leading provider of drug safety and pharmacovigilance consulting services, to deliver a comprehensive solution to enhance the quality, safety and regulatory compliance of adverse event monitoring in drug development.
Through its subsidiary, Vigilare International, WCG provides the pharmaceutical industry with integrated drug safety and pharmacovigilance services including consulting and quality assurance, adverse event processing, medical information and contact center, risk management and aggregate reporting, operational support and staffing. Prudentia's highly specialized team of global experts in drug safety and pharmacovigilance will supplement WCG's robust product vigilance solution, giving clients access to unparalleled scientific, regulatory and operational guidance in the management of their safety programs.
"In clinical trials, we are constantly weighing risks and benefits, always aiming to achieve a balance between the two," said Donald A. Deieso, PhD, Executive Chairman and CEO of WCG. "Monitoring research in real time, our safety and pharmacovigilance professionals keep patients safe by alerting us when the balance might be changing. Through our partnership with Prudentia Group, we are adding critical elements that will make our solution more powerful for clients, helping them make better, faster decisions with a greater degree of confidence. Because when your job is protecting patients, you need access to the right information at the right time to be able to make a difference."
"We are proud to partner with WCG to enhance the quality and safety of clinical development," said Vladimir Laguerre, Founding Partner, Prudentia Group. "Our organizations are committed to helping clients streamline safety operations while increasing quality and compliance. Together, we will give clients faster access to high-quality, regulatory compliant, inspection-ready data."
Prudentia will complement WCG's existing offering with enhanced organizational, operational, and technical strategies derived from decades of experience in the field of pharmacovigilance, and support clients by leading them through the implementation of those strategies, which may include helping them to move to new technologies, more cost-effective outsourcing models, or better, more compliant risk management processes.
"Our clients have always derived great value – and great results – from Vigilare's integrated, end-to-end approach to drug safety and pharmacovigilance," added James A. Bannon, PharmD, President and CEO, Vigilare International. "We are thrilled to count Prudentia's specialists, who are fluent in the technologies and techniques that drive operational excellence in pharmacovigilance, to our team of experts; their valuable insights and unique perspective will be of great benefit to our clients."
