ICON Launches FIRECREST Safety Letters and Site Question Management Supporting Regulatory Compliance and Increasing Site Support


2021-02-10 08:00:44 BioSpace


New solutions enable enhanced delivery, tracking and management of drug safety reporting and medical questions from sites DUBLIN--(BUSINESS WIRE)-- ICON plc, (NASDAQ: ICLR) a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries, today announced the release of two new digital solutions supporting clinical research sites and sponsors. The FIRECREST suite of digital clinical solutions are now integrated with the ICON Safety Reporting solution to enable electronic acknowledgement of safety letters by principal investigators, with full compliance tracking and dashboard reporting. The FIRECREST Site Question Management solution automates, accelerates and tracks medical questions from the site for quicker resolution. The pharmaceutical regulatory landscape is continually evolving, making safety reporting increasingly complex. FIRECREST Safety Letters is supporting sites to manage safety letters and increasing transparency for sponsors. It enables faster sponsor reconciliation of safety letters, both on-site and remotely, that are stored and accessible in one location with single sign-on. The solution also features compound level management, reducing duplication and empowering the principal investigators, or assigned user, to acknowledge safety letter receipt ensuring pharmacovigilance regulatory compliance. FIRECREST Site Question Management provides medical query routing according to region and role, facilitating faster responses to medical focused questions and providing governance of the process. A record of the interactions and metadata are held centrally in the site portal for oversight purposes and an exportable excel document can be filed in the eTMF. “The COVID-19 pandemic has highlighted the value of remote clinical management including the use of digital tools. We are delighted to announce the availability of two new FIRECREST solutions that are increasing speed of process and regulatory compliance.” commented Alison Liddy, Senior VP Site & Patient Solutions at ICON plc. “FIRECREST Safety Letters and Site Question Management are part of a range of digital solutions from ICON focused on automation to help improve the efficiency of site activities. FIRECREST digital solutions drive measureable efficiency and quality in clinical trials and are deployed by 18 of the top 20 pharma with 540,000 users across 233 different indications. About ICON plc ICON plc is a global provider of outsourced drug and device development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. The company specialises in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON employed approximately 15,250 employees in 94 locations in 40 countries as at September 30, 2020. Further information is available at www.iconplc.com/firecrest ICON/ICLR-G View source version on businesswire.com: https://www.businesswire.com/news/home/20210208005046/en/ ICON Media Contact: Gareth Arnold Weber Shandwick Telephone: (+44) 07944 688281 LDNWSWICONClinical@corp.ipgnetwork.com Source: ICON plc View this news release online at: http://www.businesswire.com/news/home/20210208005046/en
新的解决方案可增强药品安全报告和站点医疗问题的交付、跟踪和管理 为制药、生物技术和医疗器械行业提供药物开发解决方案和服务的全球供应商ICON plc(纳斯达克代码:ICLR)今天宣布发布两个新的数字解决方案,支持临床研究场所和赞助商。FIRECREST数字临床解决方案套件现已与ICON安全报告解决方案集成,使主要调查人员能够以电子方式确认安全信函,并提供全面的合规跟踪和仪表板报告。FIRECREST站点问题管理解决方案自动、加速和跟踪站点的医疗问题,以便更快地解决。 药品监管环境在不断变化,使得安全报告变得越来越复杂。FIRECREST安全信函支持网站管理安全信函,并增加赞助商的透明度。它使赞助商能够更快地核对现场和远程安全信件,这些信件存储在一个位置,并可通过单点登录访问。该解决方案还具有化合物级管理功能,减少重复,并授权主要调查人员或指定用户确认安全信函接收,确保药物警戒法规的遵守。 FIRECREST站点问题管理根据区域和角色提供医疗查询路由,促进对医疗重点问题的更快响应,并提供流程治理。交互和元数据的记录集中保存在站点门户中,以进行监督,可导出的excel文档可归档在ETMF中。 “新冠肺炎疫情凸显了远程临床管理(包括使用数字化工具)的价值。我们很高兴地宣布两种新的FIRECREST解决方案的推出,这两种解决方案将提高流程速度和法规遵从性。“ICON PLC现场和患者解决方案高级副总裁Alison Liddy评论说。Firecrest安全信函和现场问题管理是ICON公司的一系列数字化解决方案的一部分,这些解决方案专注于自动化,帮助提高现场活动的效率。 FIRECREST数字解决方案在临床试验中推动了可衡量的效率和质量,并被前20家制药公司中的18家采用,拥有233种不同适应症的54万用户。 关于ICON plc ICON plc是一家为制药、生物技术、医疗器械、政府和公共卫生机构提供药品和器械开发和商业化服务的全球外包供应商。该公司专注于支持临床发展的项目的战略开发、管理和分析--从化合物选择到I-IV期临床研究。圣象总部位于爱尔兰都柏林,于2020年9月30日在40个国家/地区的94个地点雇用约15,250名员工。 欲知更多资料,请浏览 www.iconplc.com/firecrest 图标/ICLR-G 在businesswire.com上查看源版本:https://www.businesswire.com/news/home/20210208005046/en/ 图标媒体联系人: 加雷思·阿诺德 韦伯·尚德威克 电话:(+44)07944 688281 ldnwswiconclinical@corp.ipgnetwork.com 来源:ICON plc 请在以下网址联机查看此新闻稿: http://www.businesswire.com/news/home/20210208005046/en