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.
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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
C-Path opens access to D-RSC database to accelerate therapy development for DMD news-medical.net - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from news-medical.net Daily Mail and Mail on Sunday newspapers.
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IMAGE: C-Path opens access to the Duchenne Regulatory Science Consortium database to qualified researchers, through its Rare Disease Cures Accelerator, Data and Analytics Platform. view more
Credit: C-Path
TUCSON, Ariz., April 22, 2021 Critical Path Institute (C-Path) announced today that it will open access to the Duchenne Regulatory Science Consortium (D-RSC) database to qualified researchers, through its Rare Disease Cures Accelerator, Data and Analytics Platform (RDCA-DAP®). The D-RSC database includes data from Duchenne muscular dystrophy (DMD) clinical trials, natural history studies and clinical data collections. The contributors of these datasets have given permission for this data to be shared externally to accelerate therapy development for DMD.
Clinical Trial Industry Veteran Paul Malan Joins Bioforum as Vice President of Biostatistics asiaone.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from asiaone.com Daily Mail and Mail on Sunday newspapers.
Clinical Trial Industry Veteran Paul Malan Joins Bioforum as Vice President of Biostatistics
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NESS ZIONA, Israel, April 20, 2021 /PRNewswire/ Bioforum, a data-focused contract research organization (CRO) serving life sciences organizations worldwide, today announced that Paul Malan has joined the company as Vice President of Biostatistics. In this new role, Malan will drive the global expansion of Bioforum s biostatistics capabilities as well as the company s functional service provider (FSP) division, designed to provide flexible, scalable partnership support to clinical trial sponsors of all sizes, with a key focus on small-to-midsize life sciences organizations and innovative startups.