WCG SafetyVigilance® notification system enables sponsors to optimize the management of pharmacovigilance notifications and meet regulatory requirements
Research Triangle Park, N.C. – December 1, 2021 – Worldwide Clinical Trials, Inc. (Worldwide), the industry’s leading global, midsize, full-service contract research organization (CRO), today announced adoption of WCG SafetyVigilance® online pharmacovigilance notification portal, hosted by WCG’s InvestigatorSpace®, which drives increased speed, accuracy, and efficiency in the global distribution of safety event communications. Worldwide offers a comprehensive suite of pharmacovigilance capabilities, including a regulatory intelligence database that is unique to the company and enhanced by WCG’s proprietary SafetyVigilance® portal.
“Worldwide has the global reach many other midsize CROs don’t have, and this enables us to complete global safety submissions because of the unique local regulatory requirements necessary. We have the support on the ground. The customers we work with depend on Worldwide to maintain the highest safety standards, no matter how challenging it may be,” said Peter Benton, President and Co-CEO, Worldwide Clinical Trials.
At Worldwide, the online pharmacovigilance notification portal enhances process improvement and management of patient safety data related to sponsor products, alleviating workflow obstacles. It also reduces administrative burdens on sponsors by driving increased speed and accuracy in distributing safety events, mitigating over-distribution and duplication of notifications, streamlining reporting, and centralizing receipt and acknowledgement of all events. SafetyVigilance® and InvestigatorSpace® are owned and operated by WCG, a proven leader in technology-enabled clinical trial solutions.
“We are thrilled to support Worldwide in their quest to streamline safety report distribution and reducing the burden it places on investigator sites. With 85 percent of trials facing massive workforce constraints due to the COVID-19 pandemic, WCG SafetyVigilance® will eliminate over-distribution and duplication, while also increasing compliance. Worldwide has taken a leading stance to safety letter delivery by providing a centralized solution to biopharma companies in order to execute higher quality, compliance-led clinical trials,” said Nicholas Slack, MBE, President of WCG.
Worldwide Clinical Trials’ full-scope pharmacovigilance services team has more than 20 years’ experience in adverse event case processing, global regulatory submissions, development safety update reports, functional service provider services, risk management, global safety database resources, and auxiliary support services. To learn more, click here.
About Worldwide Clinical Trials
Worldwide Clinical Trials is a global, midsize contract research organization (CRO) that provides top-performing preclinical and Phase I-IV clinical development services to the biotechnology and pharmaceutical industries.
Founded in 1986 by physicians committed to advancing medical science, our full-service clinical experience ranges from early phase and bioanalytical sciences through late phase studies, post approval, and real-world evidence. Major therapeutic areas of focus include cardiovascular, metabolic, neuroscience, oncology, and rare diseases. With infrastructure spanning 60 countries and offices in North and South America, Eastern and Western Europe, Russia and Asia, Worldwide is powered by its more than 2,600 employee experts. We are the cure for the common CRO. For more information, visit www.worldwide.com.