Determining appropriate stratifications and relevant clinical endpoints for specific sub-populations can be challenging. Therefore, it is necessary for development strategies to incorporate explorations and determinations of suitable biomarkers early in the development of a new therapy.
In this blog, Jonathan Pritchard, Director Business Development at Cytel, draws on his experience in commercial, clinical and technology roles within the biopharmaceutical industry and shares his insights on the primary considerations for sponsors when implementing an ePRO solution.
The CRO realized that they needed to introduce new ways to keep participants engaged and interested if they were going to successfully support this trial. The CRO identified ClinCard as the ideal software that could instantly get study participants their stipends, without adding a burden on the site staff.
We’re at the cusp of a new era for medical device research regulations. What will be necessary to meet new MDR regulations? Data – and more of it than ever. Along with the aims of MDR come a clinical trial data management complexity that might cause some growing pains for the medical device industry.
For this biotech, the big challenge was both a lack of expertise and resources needed to manage registration of trials and posting results.TrialScope provided a proven solution that optimizes the e ciency of disclosure activities,
maximizes trial data transparency, and fosters more informed, engaged patients through open research sharing.
Web-based survey tools can be extremely beneficial to pharmaceutical companies and CROs for reducing site selection cycle time as well as operational costs (not to mention the opportunity costs). But what sets site feasibility, and other clinical forms, apart from other nonclinical survey types?
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.
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