ERT、業界初の接続済み専用スパイロメトリーソリューションに乗り出す

SpiroSphere® collects research-grade spirometry data, improving site efficiency and patient performance

PHILADELPHIA – March 6, 2019 – ERT, a global data and technology company that minimizes uncertainty and risk in clinical trials, today introduced ERT SpiroSphere, the first and only spirometer designed specifically for use in global clinical trials. SpiroSphere efficiently captures research-grade clinical data that meet the most stringent regulatory requirements and ensures the highest quality data are immediately accessible by all clinical trial users.

Based on ERT’s decades of experience supporting more than 1,000 worldwide respiratory trials and extensive input from pharmaceutical sponsors and investigative sites, SpiroSphere’s advanced technology overcomes the challenges faced by site personnel that often impede the collection of precise clinical trial data.

ERT SpiroSphere enables site personnel to maintain dual focus on both the patient and data quality: smart technology like the built-in biometric fingerprint scanner ensures only trained personnel can operate the device. As connectivity is enabled via built-in Wi‑Fi, Ethernet or mobile networks, test results are seamlessly uploaded to ERT’s EXPERT® platform for centralized review and insights, and program updates are deployed quickly and conveniently for sites.

“We worked closely with leading pharmaceutical companies, key opinion leaders and investigative sites to understand their specific needs and built the industry’s first spirometer designed with all clinical trial users in mind,” said Achim Schülke, Executive Vice President of Respiratory Solutions at ERT. “While other spirometers evolved for use in clinical trials after originating as healthcare devices, SpiroSphere was purpose-built using the latest technology to deliver highly precise, research-grade data. This enables clinical trial sponsors to confidently evaluate the efficacy and safety of novel medical treatments during clinical development.”

SpiroSphere has received the 510(k) marketing authorization by the FDA and is CE marked. For more information on SpiroSphere and ERT’s other respiratory solutions, visit https://www.ert.com/SpiroSphere.

ERTについて
ERT is a global data and technology company that minimizes uncertainty and risk in clinical trials so that its customers can move ahead with confidence. ERTは50年近い臨床経験および治療経験を有しており、実際に機能することの知識と今後の出来事の予測を調和させて、基準を低下させることなく適応することができます。

Powered by the company’s EXPERT® technology platform, ERT’s solutions enhance trial oversight, enable site optimization, increase patient engagement and measure the efficacy of new clinical treatments while ensuring patient safety. Since 2013, more than half of all FDA drug approvals came from ERT-supported studies. Pharma companies, biotechs and CROs have relied on ERT solutions across 15,000 studies, spanning more than four million patients to date. ERTは、臨床試験のリスクが問題になる前にこのリスクを明確にして、顧客が臨床治療を迅速に患者に適用することを可能にします。しかも自信をもって。

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