Aims to deliver a comprehensive solution aimed at enhancing the quality, safety and regulatory compliance of adverse event monitoring in drug development.
The WIRB-Copernicus Group‘s (WCG) Clinical Services Division has partnered with Prudentia Group, a provider of drug safety and pharmacovigilance consulting services, to deliver a comprehensive solution aimed at enhancing the quality, safety and regulatory compliance of adverse event monitoring in drug development.
Through its subsidiary, Vigilare International, WCG provides 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 team of drug safety and pharmacovigilance experts will work with WCG’s product vigilance service, giving clients access to scientific, regulatory and operational guidance in the management of their safety programs.
Prudentia will complement WCG’s offering with enhanced organizational, operational, and technical strategies to 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.
In clinical trials, we are constantly weighing risks and benefits, always aiming to achieve a balance between the two. 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
said Donald A. Deieso, Ph.D.,
executive chairman and chief executive officer of WCG.
We are proud to partner with WCG to enhance the quality and safety of clinical development. 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
said Vladimir Laguerre,
Founding Partner, Prudentia Group.