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.
Can you really improve the economics and safety of clinical studies by choosing expedience over expertise? The answer is a decisive “no,” Read insights from Cenduit on their experiences with sponsors that needed then to rescue a study due to problems with their original IRT selection.
Dr. Joan Meyer, Covance Executive Director of Strategy & Planning for Inflammation, Infectious Diseases and General Medicine, discusses her team’s efforts to better understand patients’ opinions about inflammatory bowel disease trials and develop patient-centered clinical strategies to improve study recruitment.
A large pharmaceutical company asked Covance to support their studies for a diabetes Phase III program specifically to register a drug to treat Type 2 Diabetes. Read how Covance utilized its rich central laboratory services database and helped the sponsor achieve first patient in (FPI) ahead of schedule for all studies in the program and beat historical industry performance across a number of key metrics.
An emerging biopharmaceutical company was designing a Phase II trial in patients who had Type 2 Diabetes, Stage 3 chronic kidney disease (CKD) and macroalbuminuria. They were uncertain about how to balance the selection of the right patients for their trial endpoints with the ability to achieve rapid subject recruitment. Read how LabCorp de-identified clinical laboratory data helped evaluate the protocol feasibility and the overall design of the study while also making an adjustment in eligibility criteria was forecast to double the eligible patient pool – without impacting study endpoints.
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