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06.09.21 Discussions On Diversity How To Solve Pharma s Patient Problem
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Featured Editorial
Clinical Leader
PAREXEL has released a report titled
05.17.21 Are You Ready For The FDA s Data Effect Tsunami? 8 Steps To Prepare
State-of-the-art continuous manufacturing technologies are being developed and implemented to manufacture a wide variety of products. Several vendors offer development-scale to commercial-scale continuous downstream chromatography systems. When adopting continuous technology, it is critical to demonstrate that continuous downstream processes are comparable to batch-mode downstream processes and provide the supporting comparability data for technical and business decisions. Access the case study to learn more.
Featured Editorial
By Matt Collins, Cignyl, and John Giantsidis, CyberActa, Inc.
The FDA is moving forward with its Data Modernization Action Plan (DMAP), the next leg of the Technology Modernization Action Plan. Why is this a tsunami? Because you ll need to prepare yourself for the influx of questions, audits, observations, warning letters, and more! He
05.10.21 The Benefits Of A Functional Service Provider (FSP) Model In Uncertain Times
YPrime eCOA Platform Isn’t it about time for a globally proven eCOA technology that gives you peace of mind? One that provides a better user experience for patients, sites, and sponsors? YPrime’s eCOA platform delivers even the most complex protocol seamlessly. Developed to integrate intelligently with your other technologies, all modalities are available for site- or home-based trials and paired with secure web backup for guaranteed accuracy and confident, informed decision-making.
Featured Editorial
Clinical Leader
Contract research outsourcing (CRO) can be a challenging endeavor even in the best of times. Simply selecting the right model can be a difficult chore, and then there are the tasks of selecting the right partners, preparing contracts, and conducting oversight. When operating in uncertain times, the process becomes significantly more
04.07.21 AI Speeds Patient Recruitment At Health Quest
On this episode of
Business of Biotech, Nevan Charles Elam, J.D., founder of Rezolute Bio, shares the company s rationale for pursuing congenital hyperinsulinism and diabetic macular edema therapeutics by leveraging monoclonal antibodies (mAbs) and discusses the company s approach to process development and manufacturing. Listen now and subscribe so you never miss an episode.
Featured Editorial
By Ed Miseta, chief editor, Clinical Leader
Artificial intelligence (AI) has the potential to disrupt and revolutionize many aspects of clinical trials. One area in which it is already making an impact is patient recruitment. Mining electronic medical records (EMRs) for patients meeting inclusion and exclusion criteria can be tedious and time-consuming work but is a chore that seems ideal for an AI solution.