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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 ....
12.14.20 Four Steps Sponsors Can Take To Increase Patient Recruitment
Sponsor Join The Industry’s Leading Clinical Development And Commercialization Panel, Get Paid For Your Insight ISR’s Health Panel includes managers, directors, executives, and subject matter experts in clinical development and drug manufacturing who work at pharma companies, service provider companies, and research sites. Members are paid for their time (a 15-minute survey may be $40, whereas a 45-minute phone interview may be $150) and they get to choose which research opportunities to participate in. Apply here. Featured Editorial By Ed Miseta, chief editor, Clinical Leader There are many reasons for the low percentage of patients who opt to participate in clinical trials. Many do not know trials exist, most physicians do not refer their patients to trials, and even when a patient becomes aware of these studies, misconceptions and the ....