PHILADELPHIA – June 11, 2019 – ERT, a global data and technology company that minimizes uncertainty and risk in clinical trials, today announced advancements to its unique electronic Columbia-Suicide Severity Rating Scale (eC-SSRS), an electronic, self-rated patient reported outcome assessment conducted at investigative sites to assess treatment-emergent suicidal ideation and behavior (SIB) during clinical trials.
ERT co-developed and is the exclusive provider of the patient self-rated eC-SSRS, a software solution that utilizes sophisticated algorithms with adaptive branching based on patient input to enable the most sensitive and accurate assessment of suicidal tendencies available on the market today. The patient self-rated eC-SSRS is a powerful, prospective SIB assessment, providing clinicians with a tool to potentially prevent an actual suicide outcome. The solution eliminates the inter-rater bias that occurs during traditional clinician-patient interviews and enables patients to complete assessments confidentially and with more candor.
Now available as a tablet-based native app, ERT’s eC-SSRS allows patients to comfortably and privately complete the questionnaire, regardless of Internet accessibility ─ which is not always available during investigative site visits ─ and provides near real-time assessment with the patient present. If eC-SSRS identifies an at-risk patient, the investigative site is alerted immediately, enabling them to take appropriate action per the protocol, typically even before the patient leaves the site.
“Our research has proven that patient self-rated assessment delivers more reliable data than traditional clinician-administered interviews by reducing the risk of patient non-disclosure and assessor variability,” said David Elario, Executive Vice President, eCOA, ERT. “By utilizing ERT’s eC-SSRS solution, clinical trial sponsors and CROs gain greater visibility into patient safety and increased confidence in meeting regulatory guidance on SIB. The resulting reliable and high-quality data allows sponsors and regulators to document the drug’s true effect on suicidal ideation and behaviors.”
By quickly and efficiently identifying those patients that require additional clinician follow up, ERT’s eC-SSRS solution reduces investigator burden, helps clinical trial sponsors confidently make accurate and speedy go/no-go decisions, and provides more effective suicide risk assessment to ultimately ensure patient safety during clinical development.
“We are passionate about discovering ways to help researchers protect their patients and their new therapies in development,” continued Elario. “Our team is pleased to offer an enhanced version of our exclusive eC-SSRS solution that makes the assessment of SIB risk more efficient and reliable for biopharmaceutical developers. By combining smart technology with good science, we empower sponsors to improve clinical research and patient safety.”
For more information and a demonstration of ERT’s exclusive eC-SSRS solution, visit us at booth #1231 during the Drug Information Association (DIA) Annual Meeting, June 23-27 or go to ert.com/eCOA.
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 therapeutic experience, ERT balances knowledge of what works with a vision for what’s next, so it can adapt without compromising 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. 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. By identifying trial risks before they become problems, ERT enables customers to bring clinical treatments to patients quickly ─ and with confidence.