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International Clinical Trials
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Although we don’t yet know if COVID-19 will be a seasonal disease, it may recycle with other respiratory pathogens in the winter respiratory season. With that said, Phase I and II studies can be executed at any time, although off season is typically preferred so as not to confound the data with natural disease acquisition. Phase III randomised, controlled efficacy studies of vaccines aimed at preventing lab-confirmed respiratory diseases are typically conducted with the season in mind and make for an intense time for sponsors, CROs, and sites. Regardless of the phase, a potential vaccine for a pandemic respiratory virus must contend with:
An Aggressive Calendar
With a pandemic such as COVID-19, time is of the essence as the virus claims lives, overwhelms the healthcare system, upends daily life, and destabilises the global economy. These studies must be made a priority, starting with ensuring sites are ready to go when the vaccine is available. There is generally no ‘wiggle room’ in the schedule.
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About the author
Cindy Dukes has over 40 years of diversified clinical experience, including 34 years of clinical research focused in infectious diseases, vaccines, oncology, women’s health, and rare diseases. At ICON, she is the therapeutic expert for vaccines and leads ICON’s Vaccine Centre of Excellence. She also provides strategic management and oversight for studies across a number of therapeutic areas, including pivotal Phase III trials that have supported the approval of 14 vaccines as well as numerous drugs in other therapeutic areas.
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News and Press Releases |
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Smart Bioprocessing with the new Eppendorf Control System
Hamburg, February 12, 2020
Working with flexible systems that evolve with the changing needs in a lab is indispensable. With the SciVario twin, Eppendorf, a key life science company, introduces its latest bioreactor control system for small- and bench-scale applications. The intelligent controller and new, innovative bay-drawer system enables the exchange of standardized modules to flexibly adapt the controller to the changing requirements in a laboratory.
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White Papers |
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Why You Should Be Using Ultrasonic Cleaning
Natoli Engineering Company, Inc.
Clean punches and dies are essential to maintaining the integrity and efficiency of your tooling investment, as well as the quality of your product. Ultrasonic cleaning has long been considered the most effective, nondestructive way to clean tools – from medical instruments to tablet tooling. The Tableting Specification Manual (TSM) states, “An ultrasonic bath is ideal for cleaning tooling.” This high-tech cleaning process also saves time, reduces cost and is better for the environment.
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Industry Events |
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Outsourcing in Clinical Trials Europe
26-27 October 2020, Paris, France
Arena International are delighted to announce the return of Outsourcing
in Clinical Trials Europe. Part of our global series of events, this
flagship show will attract the leading clinical professionals from
across Europe. The 10th Annual event will be hosted in Paris.
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