Upgrade to Calyx RIM on Microsoft Azure drives efficiencies and patient safety
Nottingham, England and Morrisville, NC – 2022 年 8 月 2 日 – 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.
Click here for more information on the benefits of Calyx RIM.
凯理斯是一家全球顶尖的医学影像及临床信息化管理供应商，提供包括独立中心影像评估(IRC)、随机化和药品供应管理系统及服务(IRT)、临床试验管理系统(CTMS) 、临床试验电子数据采集系统(EDC)、eCTD递交及临床法规信息系统(RIM)等全面解决方案。 凯理斯服务申办方和临床研究组织 (CRO)已经近三十年，支持多达 60,000 项试验，成功帮助申办方通过了 650 个新药审批，惠及1,800 万名患者。经过近10年在中国新药研发行业的深耕，凯理斯中国团队已逾百人；通过全面深入的本土化，目前已服务近120家本土企业，同时和国内近10家顶尖药企及创新药公司达成企业级长期战略合作。凭借在临床开发方面的深厚专业知识以及在支持试验申办方和临床研究组织 (CRO) 方面逾30年的经验，凯理斯利用这种才智并激发其解决复杂问题的潜力，提供快速洞见并每天都将新药推向市场。
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.
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