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.
About ERT
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.
For more information, go to ert.com or follow us on LinkedIn and Twitter.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Phase III SELECT-GCA Trial Results Lead to FDA Approval of Rinvoq for Giant Cell Arteritis
April 30th 2025Rinvoq (upadacitinib) becomes the first oral JAK inhibitor approved by the FDA for the treatment of giant cell arteritis in adults, following robust data from the Phase III SELECT-GCA trial demonstrating its efficacy in achieving sustained remission and reducing glucocorticoid exposure.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.