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Keys To Successful Risk Management In Clinical Trials

Keys To Successful Risk Management In Clinical Trials
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Seption Group , Dawn Niccum ,

04.22.21 -- Tools And Best Practices For Trending Environmental Monitoring Data


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 production and increase the likelihood of market success.
Featured Editorial
By Crystal M. Booth, PSC Biotech
Environmental monitoring (EM) trending is an essential component of the EM program and can be used to evaluate the overall health of the facility in terms of microbial control. Part 1 of this series looked at the regulations and guidelines around EM. This article ....

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04.12.21 -- Best Practices For Implementing Decentralized Clinical Trials


04.12.21 Best Practices For Implementing Decentralized Clinical Trials
 
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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 Editorial
By Sam Brown, Nell Haslett-Brousse, Ryan Quinn, and John Theodore, Point B
While the experience design related to the patient is paramount to the adoption of decentralized clinical trial technology, the interrelated experience and incentives for all stakeholders must be fully aligned to realize the full benefits of these platforms. ....

Brian Odwyer , Caroline Keane , Raquel Telfer , Melissa Vadnais , Chuck Drucker , Patrice Hugo , Nathaniel Katz , Christine Moore , Kathy Vandebelt , Michael Murphy , Lesley Freese , Qa Elligo Health Research , Webinar Oracle Health Sciences , Meridian Clinical Research , Case Study Veeva Systems Inc , Seption Group , Elligo Health Research , Advarra Institutional Biosafety Committee , Webinar Perkinelmer Informatics Inc , Oracle Health Sciences , Dawn Niccum , Briano Dwyer , Charlie Fix , Guy Rachmuth , Worldwide Clinical , Institutional Biosafety Committee ,

Keys To Successful Risk Management In Clinical Trials


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 thinking in advance about study risks and implementing mitigation strategies in an attempt to reduce, eliminate, or accept said risks. Risk management is a comprehensive, high-level activity spanning the entirety of the clinical trial life cycle. It demands stakeholders identify critical study processes and calculate risk associated with those processes. ....

Seption Group , Dawn Niccum , விடியல் நீக்கும் ,