Clinical Ink surveyed 500+ research coordinators and investigators to discover that sites prefer eSource over paper source for clinical trial data capture. Learn how eSource helps sites cut workload in half to improve efficiency, data quality, study timelines and costs.
OmniComm Systems enlisted Applied Clinical Trials to conduct a survey on eSource and discovered our audience needed more tools to understand this growing technology area. Based on the results, they crafted a targeted webinar, a successful white paper and sponsored this eBook that features educational articles around eSource and links to OmniComm resources.
This white paper explores the current landscape of planning trends and challenges in clinical development, and presents solutions and best practices that biopharmaceutical and medical device companies are utilizing to increase planning efficiency.
The new whitepaper, “Digital Capabilities for Clinical Trials in Africa,” discusses how the lack of traditional technology infrastructure in underserved populations offers a “blank slate” environment in which to build new digital models that can be designed to advance research processes worldwide.
The safety and pharmacovigilance landscape is changing rapidly, and the new global standards for regulatory eporting – E2B(R3), eVAERS, eMDR, and IDMP – represent some of the most significant changes that the industry has seen in over a decade. Not surprisingly, implementing them requires planning and preparation from both safety and IT organizations.
Although patients make the most critical personal investment in a treatment decision, they may be inappropriately perceived as passive elements in the biosimilar developmental process if the “value proposition” places undue emphasis on economic drivers, rather than the psychosocial variables that ultimately dictate usage. Despite a substantial body of literature on the technical aspects of biosimilar development, as well as regulatory guidelines and expert opinions,1-8 [FDA Quality 2015, FDA Scientific 2015, EMA Guideline on Similar 2015, EMA Clin/Nonclin 2015] only recently have patient-related perspectives been examined. Publications on this most important topic are scant.
Over the past 20 years, randomization and trial supply management (RTSM) services (also known as IVR/IWR – interactive voice/web response systems, or more recently, IRT – interactive response technology) have been adopted across clinical trials. Such services affect how quickly a trial can start, how it is conducted and how quickly patients receive medication kits so that safety and efficacy data can be collected as soon as possible. This white paper examines how the technology and services have evolved, and describes what a modern RTSM service should offer in order to speed and simplify trial execution, while minimizing risk. It concludes by looking at future trends that will bring more automation and intelligence to clinical trial supply and dispensation management.
A proactive engagement and retention approach can improve patient sustainability, reduce costs, increase compliance and maintain the integrity of your trial’s endpoint data. CENDUIT We see things others don’t.™
Clinical organizations are under increasing pressure to execute clinical trials faster with higher quality. This white paper describes in detail the key challenges of clinical data management across multiple sources, and explains how organizations are using Oracle Health Sciences Data Management Workbench (DMW) to overcome these challenges.
This case study describes how Oracle Argus Safety and Oracle Argus Insight enabled greater and faster insight into product-safety signals, improved productivity, and streamlined and automated FDA safety reporting for Acorda, a biotechnology company focused on developing neurological disorder therapies.