Clinician rater training has been shown to be effective in improving rater reliability in dermatology studies. Rater training effectiveness and engagement are enhanced when COA data are collected electronically, with customized assessment training on ERT eCOA tablet and web. The ERT Clinical Science Team customizes clinician rater training for each dermatology assessment, with the help of Dr. Callis Duffin. Together with ERT clinical psychologists, Dr. Callis Duffin has established a gold standard for training raters on the PASI. Download this ebook to learn about the gold standard for training clinician raters, the ERT PASI assessment quizzing and scoring, and PASI electronic implementation training.
The importance of patient-reported outcomes (PRO) is evidenced by their increased use in clinical trials and in drug and device label claims. In many cases, the best way to measure symptoms and functional status is through insights provided by the patient, but few people know how to go about integrating ePRO into their clinical trials. Download this white paper to learn about a completed a Phase 2 clinical trial that used electronic PRO for the first time and identified the key decision points, responsibilities and lessons learned for incorporating ePRO into clinical trial practices.
Medidata RCM provided Zosano Pharma with a unified solution for standard operating procedure (SOP) management, for both regulated and non-regulated content eliminating their old system of using a file server system with folders containing PDF documents that needed to be tracked and traced manually.
Globalization of clinical trials, tightening regulatory requirements, a more competitive and collaborative commercial environment, and an increasingly mobile workforce requires life-sciences companies to standardize and improve regulated content management processes to ensure information is shared with the right people at the right time.
Gilead Sciences’ previous studies of Ranexa (ranolazine) relied on data from exercise treadmill parameters as the primary endpoint. But collecting data in this manner is costly, logistically challenging, and bears questionable clinical relevance — especially at the individual patient level. Learn how Gilead Sciences successfully utilized ERT handhelds to collect regulatory-compliant, patient-driven data in support of the primary efficacy endpoint in a Phase IV study of Ranexa.