Whitepapers

The current oncology and hematology drug development pipeline features a wide array of large molecule therapeutics. As a result, clinical trial protocols have grown more complex, requiring sponsors, CROs, and research sites to tackle a variety of challenges that were less common with older, more traditional therapies.

Do you leverage a quality-first mindset as you evaluate clinical trial technology? When you evaluate eCOA and IRT solutions, quality cannot be ignored, as choosing poorly can lead to data integrity issues, regulatory roadblocks, and costly delays that can postpone potentially lifesaving treatments. How can you ensure your clinical trial technology partner prioritizes quality throughout the clinical research journey? This checklist is your guide to choosing a quality-first solution.

As drug development costs continue to escalate, sponsors are incentivized to find less expensive approaches to develop their assets. FSP models provide increased operational and resourcing flexibility and different pricing plans in comparison to traditional full-service CRO offerings.

Large CROs operate with a one-size-fits-all approach. When this no longer worked for a late-stage clinical biopharmaceutical company, they turned to Catalyst Flex to design a tailored solution to meet the safety needs of this rescue study.

Speed is critical in clinical drug development. With a strong pool of resources, Catalyst Flex is able to efficiently and effectively resource studies. Learn more about this rapid rescue transition to deploy clinical research associates (CRAs) to 95 clinical sites within weeks.

This article explores the strategic importance of FSPs in clinical research, emphasizing their contributions to cost efficiencies, the acceleration of drug development, and technological innovation in trial management. Learn how FSPs provide numerous advantages.

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.

Discover how streamlining patient screening can help accelerate clinical trials. Simplifying and improving the patient journey and optimized screening processes can help improve clinical trial efficiency and stakeholder experience.

This eBook will discuss three key ways that researchers can implement AI to address data challenges, improve patient safety and outcomes, and accelerate processes.

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.

This white paper will explore the key challenges impacting clinical trial medical reviews from the perspective of Dr. Gareth Tomlinson, PhD, Director, Clinical Research Scientist at Taiho Oncology, Inc.

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.

Learn how to develop and market products and interventions that actually meet individuals' needs by incorporating patient input exist throughout the trial lifecycle

Determining the most effective locations and formats to get your clinical trial in front of willing, eligible participants can seem like a daunting task.. What is the most efficient way to introduce more targeted recruitment approaches?

In March 2024, the US FDA issued its guidance, “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together,” outlining the agency’s objectives for protecting public health as artificial intelligence (AI) and other technologies become more prevalent in healthcare.

YPrime announces a new report unveiling the top challenges that clinical trial executives face when implementing eCOA, and what to look for when evaluating new solutions.