Whitepapers

Development timelines are often extremely compressed, leading to the need for a strategic and nimble outsourcing partner. Learn how Catalyst Flex successfully completed this study ahead of planned timelines and with high-level results that confirmed the desired study endpoints were met.

The sponsor’s clinical development team needed a flexible solution to quickly visualize patient and site data. Additionally, this solution would need to aggregate data into one “single source of truth” to inform better decision-making.

AI can be applied to patient data in real time, allowing medical reviewer teams to actively monitor patient safety, with the AI alerting medical review teams to identify potential adverse events (AEs), data anomalies, critical issues for patients on treatment, and more.

Over the last two decades, clinical trials have increased in complexity by approximately 61%. Additionally, data volume has grown to be too complex and resource consuming to be processed manually. As a result, patient data is dispersed over so many various systems, that it’s impossible to get a clear picture of the patient, making it difficult to understand how they’re responding to treatment – thereby impeding a patient’s time to recovery.

By leveraging real-time data that offers unprecedented insights into physician behavior and patient outcomes, companies can gain a competitive advantage with prescribers. Alerts, powered by PurpleLab translates complex information into actionable insights, empowering companies to identify the right physicians to target, determine the most effective marketing strategies and ultimately improve patient care.

Healthcare today is evolving into precision medicine, or what the FDA refers to as personalized medicine. To stay competitive in the constantly shifting healthcare landscape, organizations across the healthcare ecosystem must embrace this targeted approach and leverage the tools needed to make safe decisions for their patients or populations. By unlocking insights provided from advanced claims data, precision medicine can assist clinicians, thereby reducing their educated guesses, improving patient outcomes, and making more informed decisions.

As medical facilities become more equipped to handle different telemedicine platforms and procedures, more clinical trials are back up and running. This also means more electronic data is being generated than ever. This Ebook will explain how to reach patients and facilities, especially in this decentralized clinical trial format.

Although biologics and biosimilar drugs only represent 2% of U.S. prescription volume, these naturally sourced medications have recently become the focus of much discussion across healthcare channels. Biologics – often considered specialty drugs – have accounted for as much as 37% of drug spending in a single year. Read more about how Biologics and Biosimilars help fight chronic disease as well as the difference between Generics and Biosimilars.

Patient selection can be a nuanced process in clinical trials, particularly those involving therapeutic areas with more complex or subjective inclusion/exclusion criteria. Determining patient eligibility may often depend on factors that require clinical expertise in such areas as disease progression, comorbidities, genetic mutations, and disease severity. Discover the role eligibility adjudication committees play in ensuring trial success.

EACs/CECs evaluate potential adverse events, participants’ safety, whether a patient meets complex eligibility criteria, and much more. Thus, the need to select the right EAC vendor is critical – selecting the wrong partner risks time, money, and success. With so many EAC vendors, it can be challenging to find the ideal partner. Fortunately, WCG has outlined the top five benefits of utilizing an independent EAC.

No clinical trial is successful without careful attention not only to how endpoints are crafted, but how they are reviewed and applied. This article will describe the use of Imaging Core Labs and Endpoint Adjudication Committees (EACs) to increase the quality and accuracy of clinical trial data. Additionally, it will clarify the differences between these critical endpoint review methods and other forms of safety review.

Is your eCOA provider built to deliver clinical trial success? Our eCOA checklist provides key questions to ask when evaluating potential vendors.

EDC Evaluation Guide

Looking for an EDC solution but overwhelmed by the process? This free guide highlights five steps to help you navigate the EDC vendor landscape and choose the right system for your study.