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05/04/21 Clinical Leader Newsletter

04.22.21 -- Tools And Best Practices For Trending Environmental Monitoring Data     Catching up to the paradigm shift in optimizing, scaling-up, and manufacturing plasmids is crucial for clinical to commercial program success for gene therapies and vaccines. With an increased demand for plasmids for targeted gene therapeutic delivery, partnering with a CDMO equipped with the capacity, expertise, and equipment for plasmid DNA production is critical to ensuring a stable therapeutic supply. Join Aji Bio-Pharma to learn about methodologies to ensure effective p...

04.12.21 -- Best Practices For Implementing Decentralized Clinical Trials   Sponsor Is clinical development prepared for the paradigm shift caused by COVID-19? The pandemic has forced the industry to reevaluate how to engage with patients and acquire patient data without direct, in-person access. Biopharmaceutical companies, medical device companies, and CROs from around the world were surveyed to explore the impact on clinical trials in this new paradigm and gain insights into their experiences operationalizing trials in a pandemic. Learn more. Featured Edi...

02.12.21 -- Partners Ready To Help With Your Study Startup Process     Your sites are likely feeling pressure as they never have before due to COVID-19. Between mass staffing shortages, mounting financial constraints, and ever-increasing new study or trial registrations—the clinical research industry is experiencing a perfect storm. See how you can help your sites overcome this new reality.     Oracle Analyze Insight for Activate Cloud Service intelligence improves transparency, communication, and collaboration with CROs by providing sponsors with timely status updates and operational i...

Keys To Successful Risk Management In Clinical Trials By Dawn Niccum, inSeption Group It is indisputable that already difficult clinical studies are progressively getting tougher — in terms of patient recruitment, regulatory compliance, etc. — as well as longer and more complex. Organizations forged in this fire, rather than burned by it, strive to run high-quality studies, remain vigilant in risk management, and embed processes that prevent data from being lost or adverse events from undermining the study as a whole. At the heart of this effort is risk management, the exercise of thinkin...