“We are pleased with ERT's implementation of the eDiary solution, which enabled us to maintain study timelines, as well as the critical endpoint data they delivered in support of our program.”
PHILADELPHIA (PRWEB) September 19, 2016
ERT, a leading provider of high-quality patient data collection solutions for use in clinical drug development, today announced that its electronic Clinical Outcome Assessment (eCOA) diaries and expert solution delivery enabled CoLucid Pharmaceuticals to achieve the primary and key secondary efficacy endpoints in its Phase 3 SAMURAI study of lasmiditan in adults with migraine.
During the pivotal trial, patients used ERT’s electronic diary (eDiary) to record migraine occurrence and to rate headache pain severity as well as presence of the most bothersome symptoms, including nausea, phonophobia or photophobia. Patients then used ERT’s eDiary at protocol-defined times post-dose to assess the degree of headache pain and the presence or absence of each associated symptom.
“ERT was able to design eDiaries that were easy enough for this affected patient population to complete while they were suffering from migraine symptoms,” said Bernice Kuca, Head Clinical and Regulatory Operations, CoLucid. “We are pleased with their implementation of the eDiary solution, which enabled us to maintain study timelines, as well as the critical endpoint data they delivered in support of our program.”
Ron Sullivan, Executive Vice President and Product Line Executive for eCOA noted “We’re honored that CoLucid relied on our eCOA system and expertise to capture this important efficacy data.”
For more information on ERT’s eCOA system, visit https://www.ert.com/ecoa.
ERT is a leading provider of high-quality patient data collection solutions for use in clinical drug development. ERT delivers a combination of technology, services and clinical consulting that increase the accuracy and reliability of patient data and improve the efficiency of the clinical development process. ERT delivers widely deployed solutions in centralized Cardiac Safety, Respiratory, and electronic Clinical Outcome Assessments (eCOA) – which includes patient-, clinician-, observer- and performance-reported outcomes – and cloud-based analytics and performance metrics. By efficiently integrating these solutions through a system built upon a scientific and regulatory foundation, ERT collects, analyzes and delivers safety and efficacy data critical to the approval, labeling and reimbursement of pharmaceutical products. For more information see http://www.ert.com. Join ERT on LinkedIn, Twitter, YouTube and Facebook.