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Calyx IRT Reaches Milestone in Supporting 500 Global Regulatory Approvals

NOTTINGHAM, United Kingdom, April 21, 2021 /PRNewswire/ -- Calyx, the eClinical and regulatory solutions and services provider most relied on for solving complex data challenges in clinical research, today announced its Interactive Response Technology (IRT) solution has reached a significant milestone. Global regulators have approved 500 medical treatments which included the use of Calyx IRT for randomization and trial supply management (RTSM) during clinical development.

Calyx IRT enables drug supply continuity, delivers unbiased randomization, and minimizes unblinding or mis-dispensing

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."

Click here for more information on Calyx's experience in delivering reliable IRT solutions that drive successful clinical development programs.


About Calyx

Through innovative eClinical solutions and services, Calyx turns the uncertain into the reliable, helping bring new medical treatments to market reliably. With deep expertise in clinical development and more than 25 years supporting trial sponsors and clinical research organizations, Calyx harnesses its intelligence and experience to solve complex problems, deliver fast insights, and get new drugs to market every day.

CTMS | EDC | IRT | Medical Imaging | RIM

Take your trials further, with intelligent insights at Calyx.ai or at LinkedIn, Twitter, or Facebook.


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News published on 21 april 2021 at 07:55 and distributed by: