Calyx IRT Reaches Milestone in Supporting 500 Global Regulatory Approvals

Global biopharmaceutical companies and clinical research organizations (CROs) have relied on Calyx IRT to enable drug supply continuity, deliver balanced and unbiased randomization, and minimize the risk of unblinding or mis-dispensing in thousands of worldwide clinical trials. The 500 approvals were granted by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), China’s National Medical Products Association (NMPA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and other regulatory agencies from around the world.

“We’re honored that so many global clinical researchers know they can rely on Calyx IRT to remove risks related to randomization and supply management for their important clinical development programs,” said Gavin Nichols, Calyx CEO. “We’re pleased to do our part in ensuring patients receive the right product at the right time during clinical trials. This became even more critical last year when many of our customers relied on Calyx IRT to come up with novel solutions to deliver study medications directly to patients to continue their important development programs during COVID-19 stay-at-home mandates.”