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Study Reveals Nearly $215 Billion Economic Burden Of Nocturia
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By Ed Miseta, chief editor, Clinical Leader
Dr. Jay Jhaveri, lead investigator for Ferring Pharmaceuticals, knew that nocturia was a burden to many patients and to the U.S. economy. Unfortunately, no HEOR existed for nocturia. For that reason, Ferring decided to produce its own. To get the real-world information it needed on the prevalence of the condition, the company turned to the National Health and Nutrition Examination Survey (NHANES).
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Analyzing The Top Clinical Trial Technology Trends
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By Mathini Ilancheran, principal analyst, R&D, Beroe Inc.
Technology plays a critical role in drug development and the R&D value chain by revolutionizing clinical trials and decreasing the failure rate. Though the supply of technology has been increasing and regulation of innovative methods is easing, pharmaceutical companies have been slow to use the emerging technologies due to the ambiguity prevailing around this space and a highly fragmented supply market. This article outlines the key technologies that have a high impact across trial phases.
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Successfully Managing The Unique Demands Of Cell Therapy Supply Chains
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Article
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By Rachel Griffiths, PCI Clinical Services, and Dr. Matthew Lakelin, TrakCel
While cell therapy is playing an increasingly important role in the treatment of a variety of conditions, the real challenge in delivering it successfully is not necessarily in the manufacturing protocol alone, but in the administration and coordination of the complex supply chain as a whole. Therefore, supply chain risk management (SCRM) becomes an essential part of the process. Risks associated with production and transportation need to be assessed in advance and formulated into a robust risk assessment strategy.
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Commonalities Of Rare Diseases
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Article
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By Jennifer Dennis-Wall, Ph.D.,
Biorasi
Along with a fear of a low ROI, pharmaceutical companies have been hesitant to take on rare disease drug development because the indications can be challenging to study. Although each rare disease is unique, some elements of the clinical operations of rare disease trials are consistent across indications. Here are some common challenges experienced during the course of researching rare diseases.
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5 Must-Haves In A Contract Packaging Partner
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Article
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By Yves Massicotte,
Ropack Pharma Solutions
A contract packaging partner should function as an extension of the pharma’s organization, so careful consideration should be devoted to initiating this relationship.
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Clinical Supply Optimization: Enhanced Service Model Saves Client Time On Supplies
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Case Study
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Thermo Fisher Scientific
The vice president of manufacturing for a clinical-stage biopharmaceutical company faced an avalanche of work when a reorganization left him without a clinical supply manager. Planning to start five new clinical trials in six months while managing quality assurance, manufacturing, and supplies for new and ongoing studies, he turned to his Fisher Clinical Services account executive with a simple question: “How am I going to do all that?”
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Managing eCOA Data: Principles And Best Practices For Data Managers
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E-Book
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Signant Health
With the quality of data captured throughout a trial playing a crucial role for the success or failure of a study, clinical data management (CDM) is a key element of any research program. During a study life cycle data managers will deal with data from many sources, such as MRI scans, ECGs, and lab data, as well as eCOA, all of which are equally important.
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SCOPE Summit 2020 takes place February 18 to 21 in Orlando, FL. Over the course of four stimulating days of in-depth discussions in 20 different conferences, with three plenary keynote sessions, the annual Participant Engagement Awards, and the ever-popular interactive breakout discussions, the programming focuses on advances and innovative solutions in all aspects of clinical trial planning, management, and operations. www.SCOPEsummit.com
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