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10/15/21 Clinical Leader Newsletter

When replacing your CRO becomes the only feasible option, a partner experienced in such transitions — as well as sensitive to the impact on...

10/06/21 Clinical Leader Newsletter

05.06.21 -- Patient And Site Partners Ready To Help With Your Trials     All science aside, operational issues can be a huge impediment to rapid, safety-conscious, cost-effective research. Implementing a decentralized eSource platform wherever it makes sense can make a big difference — and Clinical Ink is the hands-down leader in virtual trials.     Seven of the top fifteen global biopharmaceutical companies are on a single clinical technology platform, leveraging one environment, operati...

05.05.21 -- Partners Ready To Support Your Phase I-III Trials     Cytel brings its expertise in adaptive designs to the design and implementation of the industry’s most innovative clinical trials. These highly flexible trials raise peculiar challenges for enrollment, data collection and regulatory submission. Why not have the industry leaders in adaptive design working on your adaptive trials?     Are you preparing to initiate your clinical trial? Trying to get your next milestone quickly...

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...

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 ...

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, communica...

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 under...