Certara Adopts TrialAssure ANONYMIZE Solution to Speed Life Science Industry Need to Meet Regulatory Requirements for Data Sharing

Certara采用TrialAssure ANONYMIZE解决方案,加快生命科学行业满足数据共享监管要求的需求

2021-03-17 00:30:06 BioSpace

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TrialAssure’s ANONYMIZE for Data provides a cutting-edge anonymization application for datasets that allows clinical trial sponsors to anonymize all structured clinical trial data, including datasets and tables, and is entirely configurable to sponsor specifications and architected to take advantage of machine learning capabilities. Through this collaboration, Certara’s regulatory science division, Synchrogenix, will utilize TrialAssure ANONYMIZE in a software-as-a-service (SaaS) model to provide a tech-enabled Anonymization service for their client roster of more than 1,650 global biopharmaceutical and biotech companies across 61 countries. “We are pleased to partner with TrialAssure to build on our strengths as the leading technology and services provider in clinical trial disclosure and transparency,” Mari Welke, Director, Safety and Innovation, Synchrogenix. “Certara will add TrialAssure’s anonymization technologies to our suite of tech-enabled services, including ClinGenuity™ for redaction and PODIUM™ for patient engagement to provide clients with a full range of options to meet regulatory requirements.” In recent years, pharmaceutical companies and other sponsors of clinical trials have been under increased pressure to disclose data and documents from regulations and requirements that include the European Medicines Agency (EMA) Policy 0070 and Health Canada Public Release of Clinical Information (PRCI). “Certara has a long history of partnering with best-in-class technology solutions, and our collaboration is an important endorsement to TrialAssure’s commitment in strong disclosure and transparency solutions that are built to evolve with the future of the pharmaceutical industry,” said Mohamad Zahreddine, Chief Information Officer, TrialAssure, and member of the Forbes Technology Council. “Through this collaboration, Certara will be able to provide even faster solutions for its robust client base.” To learn how to meet and exceed data sharing requirements with Certara, visit: https://www.certara.com/regulatory-science/transparency-disclosure/ About TrialAssure TrialAssure is a leading, global clinical trial disclosure, data sharing, and transparency software company with unmatched experience in helping navigate complex regulatory compliance challenges. TrialAssure provides fast, affordable, and informed technology and service solutions to help clinical trial sponsors meet clinical trial registration and results reporting, document and data anonymization, patient engagement, and compliance reporting goals. Established in 2009, TrialAssure regularly adapts to ever-changing clinical trial disclosure and data transparency requirements and was recently named Data Solution of the Year—Healthcare in the Data Breakthrough Awards. For more information, visit: www.trialassure.com or follow TrialAssure on LinkedIn. About Certara Certara accelerates medicines using biosimulation software and technology to transform traditional drug discovery and development. Its clients include more than 1,650 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 61 countries. For more information, visit www.certara.com. View source version on businesswire.com: https://www.businesswire.com/news/home/20210316005086/en/ For TrialAssure: Don McLean, +1-734-245-0165, dmclean@trialassure.com For Certara: Jieun Choe, +1-609-716-7939, jieun.choe@certara.com Source: TrialAssure View this news release online at: http://www.businesswire.com/news/home/20210316005086/en
TrialAssure的ANONYMIZE for Data提供了一个前沿的数据集匿名化应用程序,允许临床试验发起人匿名化所有结构化的临床试验数据,包括数据集和表,并且完全可配置为发起人规范,架构为利用机器学习能力。 通过这一合作,Certara的监管科学部门Synchrogenix将利用软件即服务(SaaS)模式中的TrialAssure ANONYMIZE,为其客户名册上61个国家的1650多家全球生物制药和生物技术公司提供技术支持的匿名服务。 Synchrogenix公司安全与创新部主管Mari Welke说:“我们很高兴与TrialAssure合作,加强我们作为临床试验披露和透明度方面的领先技术和服务提供商的优势。Certara公司将把TrialAssure公司的匿名技术添加到我们的技术支持服务系列中,包括用于编辑的Clingenuity™和用于病人参与的Podium™,为客户提供满足监管要求的全方位选择。“ 近年来,制药公司和临床试验的其他赞助商受到越来越大的压力,要求他们根据法规和要求披露数据和文件,这些法规和要求包括欧洲药品管理局(EMA)政策0070和加拿大卫生部临床信息公开发布(PRCI)。 TrialAssure公司首席信息官兼福布斯技术委员会成员穆罕默德·扎赫雷丁说:“Certara公司与一流的技术解决方案建立伙伴关系的历史悠久,我们的合作是对TrialAssure公司致力于提供强有力的披露和透明度解决方案的重要认可,这些解决方案是为了适应制药业的未来而建立的。通过这种合作,Certara将能够为其强大的客户群提供更快的解决方案。“ 欲了解如何满足和超过Certara的数据共享要求,请访问:https://www.Certara.com/regulatory-science/transparency-displayment/ 关于TrialAssure TrialAssure是一家领先的全球临床试验披露、数据共享和透明度软件公司,在帮助应对复杂的法规合规挑战方面具有无与伦比的经验。TrialAssure提供快速、廉价和知情的技术和服务解决方案,帮助临床试验发起人实现临床试验注册和结果报告、文档和数据匿名化、患者参与和合规报告目标。TrialAssure成立于2009年,定期适应不断变化的临床试验披露和数据透明度要求,最近在数据突破奖中被评为年度数据解决方案-医疗保健。欲了解更多信息,请访问:www.TrialAssure.com或访问LinkedIn上的TrialAssure。 关于Certara Certara利用生物模拟软件和技术加速药物的开发,以改变传统的药物发现和开发。它的客户包括超过1650家全球生物制药公司、领先的学术机构,以及遍布61个国家的关键监管机构。欲了解更多信息,请访问www.certara.com。 在businesswire.com上查看源版本:https://www.businesswire.com/news/home/20210316005086/en/ Don McLean电话:+1-734-245-0165+1-734-245-0165电子邮件:dmclean@trialassure.com dmclean@trialassure.com Certara:Jieun Choe,+1-609-716-7939+1-609-716-7939+1-609-716-7939+1-609-716-7939+1-609-716-7939 来源:TrialAssure 请在以下网址联机查看此新闻稿: http://www.businesswire.com/news/home/20210316005086/en

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