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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 ....
Bringing Clinical Trials To Patients With The Decentralized Model By Rosamund Round, Vice President, Patient Innovation Center, Parexel® Before the pandemic, Parexel was experienced at executing decentralized clinical trials to improve patient access and experiences. Since, COVID-19, which has had a huge impact on global clinical trials, sponsors, CROs, sites, and patients have pivoted to adapt to a more home- or community-based approach. More than 100 DCTs later, Parexel is at the forefront of industry change. “Everything we do is built around the patient and caregiver to make participation as easy as possible.” says Rosamund Round, Vice President of Parexel’s Patient Innovation Center. Central to navigating the dynamic research landscape is Parexel’s ability to harness and apply patient insights during DCT planning to ensure that every part of the strategy is formulated with the patient in mind. This approach, along with expertise in global regulatory requir ....