As we enter the 2019 labeling landscape—with changing regulations and slashed submission timelines—producing labels with 100% accuracy is proving to be increasingly complex and load-bearing for clinical supply teams. In the months to come, here are a few key topics that we are keeping an eye on.
Bryan Clayton, Vice President, Strategic Solutions, YPrime recently presented a webinar on IRT technology. This article recaps the discussion on IRT terminology, SDLC methodologies and how different approaches can save time, risk and cost.
With such abundant clinical trial opportunities in China, and such a wide range of innovative eClinical technology available to take advantage of them, there has never been a better time to be a clinical researcher.
The industry is seeing continued regulatory guidelines aimed at moving sponsors and technology companies to modernize clinical studies. In addition to that a common challenge is a breakdown in communication throughout the study lifecycle.. Kevin Landells, Vice President of Project Management at Cenduit, shares his insights on an eClinical technology provider consistently achieve client satisfaction.
Highly variable demand cycles, further de-risking the business, and increasingly inexperienced interactive response technology (IRT) stakeholders are a few of the crucial, data-driven challenges facing studies. Learn how industrializing OpEx drives quality patient outcomes and provides a means for continuous improvement.
Jennifer Aquino, Chief Operating Officer at Cenduit recently had the opportunity to visit with several clients and opinion leaders on a year-end “listening tour,” to discuss their issues and goals for 2019 and beyond. Read what they had to say regarding the industry’s challenges and opportunities.
The clinical trial informed consent process is in dire need of optimization. High patient attrition rates indicate that we’re not doing enough to ensure patients truly understand the nature of their participation in clinical trials. We can do better. This webinar explains how organizations are using eConsent to enhance patient engagement, discusses regulatory considerations around eConsent, and more.
Sponsors, CROs and sites around the world partner with Greenphire to enable a secure and compliant electronic payment technology that makes their lives easier and removes the barriers to successful recruitment and retention. Watch this video to see how it works!
While translation and cultural adaptation are time-intensive and require domain expertise, there are emerging best practices that not only save time, but also eliminate unnecessary work and reduce risk of error and timeline delays. his webinar will discuss the process of translation and cultural adaptation to support eCOA implementation on a global scale.
“Configurable” and “customizable” are two commonly-used descriptors for interactive response technology systems that support clinical trials. Interpretations of these terms can vary widely. This webinar discusses definitions and system functionality in the context of configurable and customizable and includes systems development life cycle (SDLC) methodologies, the impact on timelines and cost and common applications in interactive response technology system designs.
Watch Almac’s on-demand webinar to gain an understanding of data integrity regulations and key considerations when utilizing a computerized system to manage temperature data during clinical trials. This webinar will demonstrate how a secure, validated system is key in ensuring effective collection and management of accurate temperature data from the entire clinical supply chain.
Software implementation does not have to be a scary proposition. In this video, implementation experts – with a 100% success rate – discusses what works and why.
Up to 60% of clinical development time and 40% of cost are spent on patient recruitment. Data can help, but simply accessing more data only muddies your decision making. With Covance, you get the right analysis on the right data to empower your studies. Recruit eligible patients that fit your protocol faster, identify and secure proven and/or new sites, forecast and measure progress more efficiently. With Covance’s proprietary data, your program hits its mark.
New-generation IRT systems go beyond the fundamentals of randomization and drug supply to offer more functionality, visibility, flexibility and quality. Today’s advanced systems allow sponsors to fully control materials management, site and patient interactions, dosing scenarios, and treatment schedules down to individual patient and material unit levels. The IRT Worst Case Scenario Survival Handbook was built from YPrime’s knowledge gained, lessons learned, and creative solutions used to overcome study challenges and keep projects on track, no matter what.
YPrime’s IRT+ goes beyond traditional IRT capabilities of patient randomization and drug supply management with control and a real-time view into critical functions and flows of a clinical trial - involving patient interactions, site activities and clinical supply management.