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2021 年 6 月 10 日

Calyx Supports over 100 COVID-19 Vaccine Authorizations

Calyx RIM publishing module relied on for critical submissions of coronavirus vaccine trial data to global regulatory bodies.

Nottingham, UK – 2021 年 6 月 10 日 — Calyx, the imaging and eClinical 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.”

Gavin Nichols, Chief Executive Officer, Calyx

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 24×7 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.

Click here for more information on Calyx RIM.

关于凯理斯

通过创新的 eClinical 解决方案和服务,凯理斯使不确定转为可靠,从而帮助将新的医疗方法更快地推向市场。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 25 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,提供快速见解并每天都将新药推向市场。

CTMS | EDC | IRT | 医学影像 | RIM

如需了解有关如何使您的试验进展得更深入和更快的信息,请访问 calyx.ai、LinkedInTwitterFacebook

媒体联系人:

Christine Tobin | [电子邮件地址受保护] |+1 412-628-8598


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