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06 28 21 -- How Lyndra Uses Trial Partners To Reinvent Medicine

06 28 21 -- How Lyndra Uses Trial Partners To Reinvent Medicine
clinicalleader.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from clinicalleader.com Daily Mail and Mail on Sunday newspapers.

05 26 21 -- How Takeda Is Expanding Its Real-World Data Through A Global Myeloma Trial

05.26.21 How Takeda Is Expanding Its Real-World Data Through A Global Myeloma Trial     Combining drugs that may have been shelved with established, safe, and approved drugs has the potential to bring safer, effective therapies to patients. Attend this webinar to learn more about key trends, understanding technical challenges, and shortening timelines by smart working in parallel for scale-up and late-phase development. Click here to register. Featured Editorial By Dawn Marie Stull, Takeda Oncology There is more focus than ever before on tailoring treatment plans to the unique needs of patients. One way to ensure that we as an industry are delivering the most value is by examining real-world data (RWD) throughout the drug development process.

Starting studies right can ensure a stronger finish: Oracle

Starting studies right can ensure a stronger finish: Oracle A leader from the clinical trial technology firm suggests ways to design research from the start to help accelerate studies and avoid stumbling blocks. While clinical trials have made a number of advancements in decentralized design, data processing, and other aspects, one area remains a pervasive challenge: startup time. Outsourcing-Pharma recently spoke with Jae Chung, vice president of product management and strategy with Oracle Health Sciences, about solutions to optimize the process, and to increase overall chances of success. OSP:  Why is shortening the timeline of a study desirable? What are some of the forces contributing to the pressure to shorten the study cycle, end to end?​

05 17 21 -- Are You Ready For The FDA s Data Effect Tsunami? 8 Steps To Prepare

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

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