WCG™, a leading provider of clinical trial solutions, today announced WCG Total Safety™, a first-of-its-kind, end-to-end solution for handling case processing, aggregate reporting, drug safety, and safety letter distribution for emerging biopharmaceutical companies. This new offering creates a next generation safety management workflow, which enables strict adherence to regulatory directives and guidance, backed by a vast team of industry-recognized safety experts to manage the process from study launch through closeout.
“At WCG, we understand the mission critical nature of drug safety,” said Nicholas Slack, MBE, President of WCG. “We have re-engineered the industry’s status quo safety management process – which is intricate, onerous, and risky – and simplified it in a manner that facilitates increased protections for patients, stronger regulatory compliance, and less burden on investigators and staff in the clinical trial process. Leaving safety to chance is a risky proposition for all organizations, especially earlier stage biopharmaceutical companies. It is the wrong choice for patients, and it leads to a lower probability of asset approval by regulatory bodies. Through our WCG Total Safety™ solution, we are making drug safety a competitive advantage in the development process for earlier stage biopharmaceutical companies. Integrity and compliance combined with efficiency is always a good choice,” he added.
A cost-efficient operational model, WCG Total Safety™ helps emerging biopharma companies avoid building internal drug safety infrastructure, eliminates the need for capital investment in internal IT software systems, and reduces burden on sites to review safety documents. In addition, all safety data is collected from global investigator sites and CROs into a single safety database, in real time, saving valuable time and significant expense.
Clients have chosen WCG Total Safety™ because WCG understands the safety profile of a biopharma’s product with a level of intelligence that is unmatched. Impressed by the background of subject matter experts, organizations appreciate how WCG handles and manages global safety events as well as makes recommendations for how to handle regulatory audits. Best of all, biopharma companies reduce the annual overhead costs required to run their portfolio.
Although the comprehensive offering is relatively new, clients of WCG have been using elements of the solution for several years and have achieved dramatic results, including: $40,000 saved per average study, automated compliance regulations for over 125 countries, and reducing redundant safety reports by up to 50%.
Added Steven Beales, Vice President of Scientific and Regulatory Review at WCG, “For over 20 years, we have partnered with organizations to optimize their safety processes. The vitality of their safety strategy is fundamental to the success of the overall clinical development strategy. We are proud to offer our clients a comprehensive solution that is reliable and powerful. The results will no doubt generate a mass amount of excitement within the emerging biopharmaceutical community.”
To learn more about WCG Total Safety™ please visit: https://www.wcgclinical.com/services/safety-reporting/.
WCG is the world’s leading provider of solutions that measurably improve the quality and efficiency of clinical research. Comprised of two segments, Ethical Review and Clinical Trial Solutions (CTS), WCG enables biopharmaceutical companies, CROs, and institutions to advance the delivery of new treatments and therapies to patients, while maintaining the highest standards of human participant protection. For more information, please visit www.wcgirb.com, www.wcgclinical.com or follow us on Twitter @WCGClinical or LinkedIn.