PHILADELPHIA – October 15, 2018 – ERT, a global data and technology company that minimizes uncertainty and risk in clinical trials, today announced RapidQT, a new alert service available through SafePatient ECG, its centralized cardiac safety assessment solution for late phase clinical trials. RapidQT expedites the analysis of screening and other ECGs – delivered within only 4 hours â to optimize patient enrollment and ensure patient safety in large, complex global clinical trials.
“Clinical trials that rely on site-managed ECGs are wrought with data quality challenges, including significant data variability resulting from automated machine measurements and analysis conducted by different personnel at each investigative site,” said Robert Kleiman, M.D., Vice President, Cardiology and Chief Medical Officer, ERT. “This leads to poor inclusion and exclusion decisions, which not only delay clinical trial timelines but also pose potential danger to patients; those who are falsely included could be at risk for a cardiac event and those who are falsely excluded miss out on treatment options that mighthave benefitted them.”
SafePatient ECG overcomes these challenges by minimizing the risk of false negative and false positive ECG results so investigative sites can safely enroll patients in clinical trials. Sponsors who leverage SafePatient ECG and equip investigative sites with RapidQT have confidence that only eligible patients are enrolled in clinical trials and, as result, benefit from optimized patient enrollment which can accelerate study timelines.
“At a time when clinical trial costs and timelines continue to grow – largely because nearly half ofinvestigative sites fail to meet enrollment targets â every incorrectly excluded patient or improperlyincluded patient is one too many,” continued Dr. Kleiman. “By offering RapidQT, we’re enabling clinicaltrial sponsors to take the many benefits of centralized ECG analysis to another level. Now, clinical trial sponsors who leverage the improved data quality benefits delivered through SafePatient ECG can also arm investigative sites with a reliable tool that delivers ECG analysis while the patient is still at the site, so they can act quickly, and with confidence, as they make important enrollment and dosing decisions during clinical trials. RapidQT can enable sponsors to maximize patient enrollment as well as extend their abilityto protect patient safety.”
For more information on RapidQT and SafePatient ECG, visit ert.com/cardiac-safety.
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. With nearly 50 years of clinical and therapeuticexperience, ERT balances knowledge of what works with a vision for what’s next, so it can adapt withoutcompromising standards.
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. In 2017, ERT supported more than 60% of all FDA drug approvals. Pharma companies, biotechs and CROs have relied on ERT solutions in 13,000+ studies, spanning more than three million patients to date. By identifying trial risks before they become problems,ERT enables customers to bring clinical treatments to patients quickly â and with confidence.
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