Calyx Supports over 100 COVID-19 Vaccine Authorizations

Calyx, the eClinical and Regulatory solutions and services provider most relied on for solving complex data challenges in clinical research, today announced it has reached a milestone in its support of global COVID-19 vaccine authorizations. To date, over 100 COVID-19 vaccine authorizations have been granted by worldwide regulatory bodies based on clinical trial data submitted via Calyx's proven Regulatory Information Management (RIM) system.

"We are so proud of the role Calyx has played in the world's fight against the COVID-19 pandemic," said Gavin Nichols, CEO of Calyx. "It's extremely rewarding to know that people across 85 countries now have access to COVID-19 vaccines based on our customers' continued trust in Calyx RIM for their critical global regulatory submissions."

The Calyx RIM publishing module enables pharmaceutical companies to easily compile and submit comprehensive dossiers to global regulators as they seek authorization to bring new medical treatments and vaccines to patients around the world. A flexible system that leverages Microsoft's cloud-based Azure native technology, Calyx RIM enables users to stay ahead of – and compliant with – the constantly evolving requirements outlined by different regulatory bodies around the world. For the COVID-19 vaccine authorizations, Calyx's expert regulatory teams provided dedicated, on-call 24x7 support to ensure optimal efficiency throughout the rolling reviews of these compressed publishing windows.

Calyx recently launched RIM v7.0 providing customers with access to valuable new system features like Power BI analytics and fully managed file sharing in the cloud, while enabling them to maintain patient safety and ongoing compliance with global regulatory requirements.

About Calyx

Through innovative eClinical and Regulatory 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.