Regulatory publishing solution selected based on reliability and innovation
Nottingham, England and Morrisville, NC – 2021 年 10 月 25 日 – Calyx, the eClinical and Regulatory solutions and services provider most relied on for solving complex data challenges in clinical research, today announced that one of the world’s Top 10 pharmaceutical companies executed a contract to continue its use of the Calyx Regulatory Information Management (RIM) system for critical submissions of clinical development data to global regulators through 2026.
The Calyx RIM publishing module enables pharmaceutical companies to easily compile and submit comprehensive dossiers to global regulatory authorities. Designed by Calyx in-house regulatory experts, Calyx RIM is a proven, robust tool that optimizes the regulatory submission process and is continually updated to reflect worldwide health authorities’ evolving submission specifications.
The Top 10 pharmaceutical company made its selection based on decades of experience with the Calyx RIM solution and the trust that Calyx will continue to support submissions across the company’s complex global portfolio. The value of the RIM system is further increased through Calyx’s partnership with Microsoft and its use of innovative, cloud-based technology that keeps customers ahead of evolving regulatory requirements. Calyx RIM on Microsoft Azure provides tailored, direct delivery of system updates based on users’ needs and schedules, ensuring minimal disruption and ongoing compliance with global regulatory requirements.
“We value the trust this global pharmaceutical company has placed in Calyx and are delighted to extend our relationship as we support the important work they’re doing to bring new medical treatments and vaccines to patients around the world,” said John Blakeley, Chief Commercial Officer at Calyx.
Click here for more information on the benefits of the Calyx RIM system.
关于凯理斯
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方面逾 25 年的经验，凯理斯利用其智慧和经验来解决复杂问题、提供快速见解并每天都将新药推向市场。
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联系人：
Christine Tobin | christine.tobin@calyx.ai | +1 412-628-8598
