Krka Extends Use of Calyx Regulatory Information Management System based on Decade of Successful Experience


Calyx, the eClinical and Regulatory solutions and services provider relied on for solving complex data challenges in clinical research, today announced that long-term client, Krka – one of the world’s leading generic pharmaceutical companies – is expanding its investment in the Calyx Regulatory Information Management (RIM) system for an additional five years.

“We chose to continue our relationship with Calyx based on our successful experience working with their regulatory experts over the past decade, and our trust in the robustness of the Calyx RIM system,” said Krka. “We’re excited about the investment Calyx has made in innovating the system with reliable cloud technology, which will help us to ensure patient safety, even during system updates.”

Since 2011, Krka has relied on Calyx RIM to comply with increasingly complex global publishing requirements and for the management and tracking of detailed product information, registrations, and authorizations. Krka’s contract extension includes an upgrade to Calyx RIM on Microsoft Azure for increased efficiencies, including simplified activities and tailored, direct delivery of system updates to minimize operational disruptions.

“We value the trust that Krka continues to place in Calyx RIM and are delighted to extend our relationship as they strive to comply with evolving worldwide regulations and ensure patient access to much needed medical treatments,” said Jo English, Vice President, Regulatory Information Management, Calyx

More than 20 million regulatory records have been seamlessly migrated into the Calyx RIM system, representing over 1 million global submissions to date. Notably, over 100 COVID-19 vaccine authorizations have been granted by worldwide regulatory bodies based on clinical trial data submitted via Calyx RIM.