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

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Aug 02, 2022, 07:55 ET

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NOTTINGHAM, England and MORRISVILLE, N.C., Aug. 2, 2022 /PRNewswire/ -- 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.

Calyx's Jo English values the trust that Krka continues to place in Calyx RIM after their 10+ years of successful experience with the regulatory system

"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.

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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 30 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.

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About Krka

Krka (LJSE: KRKG) was established in 1954 and has developed into one of the leading generic pharmaceutical companies in wider Europe. Globally, it ranks among the top 20 generic companies, and is present in overseas markets and Asia. Krka has a broad portfolio of effective and innovative medicines and a strong development pipeline of 170 products. Krka's medicines are available in unique strengths and combinations, innovative dosage forms, including sustained release dosage forms, and are manufactured in advanced and patented technological processes. Our flexibility allows us to be agile and first to market. Krka has grown to become an international company with 12 thousand employees and global presence in more than 70 markets around the world. In addition to the 47 subsidiaries and representative offices abroad, the company's international presence is consolidated through its own production plants in Slovenia, Poland, the Russian Federation, Croatia, Germany, and now in China. Krka's products are marketed under our own brand names, ensuring market recognition. New products are constantly being added to the wide Krka product range, reinforcing the company's ability to enter new therapeutic areas. Krka's group business model is based on a high degree of vertical integration at all levels of its operation.

SOURCE Calyx