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By Ed Miseta, chief editor, Clinical Leader
FDA guidance on protecting the safety of patients suddenly has sponsors scrambling for technologies that will allow them to gather patient data without having them travel to hospitals and clinics. Many companies are also contacting institutional review boards (IRBs) for guidance on modifying protocols to better accommodate patients. I took this opportunity to speak with Donald Deieso, Ph.D., chairman and CEO of WCG, to discuss the current state of clinical trials and where we can expect the industry to go from here.
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Psychiatry is an area that Jonathan Javitt never planned to work in. In fact, he still jokes that he flunked a psychiatry class while in medical school. However, life has a way of changing your focus. For Javitt, who is now the cofounder and CEO of NeuroRx, that happened 11 years ago when one of his closest friends approached him to say he was battling depression.
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Article
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A Q&A with Justin Schroeder, PCI Pharma Services
The need for clinical trials to meet the requirements of regulators, deliver high-quality data, and come in on budget has led to study designs that focus on timeliness and convenience, yet may unduly burden and inconvenience patients. Today, priorities are changing as sponsors realize studies designed around the needs of patients also result in benefits to other stakeholders. This has led to the rise of patient-centric clinical trials.
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Article
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By Craig Morgan,
Oracle Health Sciences
Many facets of a clinical trial are unpredictable. Patient enrollment, a critical and often troublesome step, can vary widely within regions, countries, and sites, as well as across therapeutic areas. This unpredictability increases the complexity of clinical trial planning. This is why scenario planning is so valuable and critical in helping to manage the variability in clinical trial setup decisions.
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White Paper
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LabConnect
Local laboratory data normalization is a routine process in clinical trial data management. However, even with standardized collection and transport procedures across the laboratories, there is often variability to account for. This paper highlights the modern need for access to local laboratory data in near real time.
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White Paper
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PerkinElmer Informatics, Inc
There is an opportunity for medical monitors to redefine their role in a new era of tech-enabled, productivity-focused digital data analysis. In this white paper, we’ll explain what distinguishes this emerging role from its more traditional predecessor, and we’ll leave you with a keen sense of how to identify, hire, and empower a modern medical monitor to help your next study proceed toward submission more productively, and with greater data integrity, than ever before.
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Application Note
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Philips Respironics
The Philips Health Band (PHB) is a wrist-worn wearable device that leverages accelerometry and photoplethysmography (PPG) sensors to deliver sleep, cardiology, respiratory, and energy expenditure (EE) endpoints. In this study, the respiration rate was evaluated for accuracy and performance in adults with (or at risk) for life style-related chronic disease using the Philips Health Band.
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Case Study
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Thermo Fisher Scientific
It’s impossible to run a global clinical trial of an investigational diabetes drug without ancillary materials. And, as one leading multinational pharmaceutical company recently learned, managing ancillaries can be a challenge every bit as complex as the trial itself.
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Pharmacovigilance And Risk Management Strategies Conference
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Virtual Event
January 26 to 28, 2021 | 9:45 a.m. to 5:00 p.m.
DIA's Pharmacovigilance and Risk Management Strategies Conference provides the foundation for strong strategic planning and practical decision-making in pharmacovigilance programs. Developed by recognized experts from the biopharmaceutical industry and global regulatory agencies, this conference provides the background, context, and opportunities to discuss current challenges and to problem solve around issues that matter most to professionals working in the field.
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Have you heard of Life Science Leader?
Check it out today for access to candid interviews with top-tier executives on how they do business.
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