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| home > white papers > Contemporary Issues in Comparator Trial Supply - Clinigen CTS |
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 WHITE PAPERS |
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Clinigen CTS
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Contemporary Issues in Comparator Trial Supply
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The past five years has seen a great deal of change in clinical trial management. As the bio-pharma industry looks to speed development times and consolidate new product pipelines, in a quest for improved R&D efficiency, it is no surprise that phase III trial design, planning and execution in particular has been under great scrutiny. Cost of comparator agents alone has escalated to up to $100m per year for top companies (and is predicted to grow further). Consequently innovative approaches, novel project planning and increasingly close partnerships with specialist outsourcing service providers have come to the fore.
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News and Press Releases |
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Gerresheimer manufactures sustainable primary plastic packaging
Düsseldorf, January 14, 2020. Consumers are placing great importance on eco-friendly plastic packaging products, specifically – and increasingly – on sustainable packaging solutions that can be disposed of in an environmentally friendly way. At Gerresheimer, therefore, innovation and environmental protection go hand in hand. A pioneer in the quest for greater sustainability, Gerresheimer offers an extensive standard range of plastic packaging and devices customized solutions made from PET, R-PET, and BIO-PET plastics.
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White Papers |
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Cleaning Validation: What do you need to consider to ensure a successful outcome?
RSSL
Cross contamination must be avoided in the Pharmaceutical industry at all costs and successful cleaning validation ensures that patients are not put at risk due to cross contamination.
The process can be divided into a number of sections each of which must be fully understood and areas of concern addressed to ensure a successful outcome across the entire process. This spans both the manufacturing and subsequent analytical and microbological support.
The data used to confirm a positive/successful cleaning validation is underpinned by the results of validated analytical methods. It is essential that these results are truly representative as patient safety is based upon the absence of equipment residues.
So what are those areas of concern, what affects your ability to get a successful outcome and what do you need to consider when carrying out a Cleaning Validation exercise?
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Industry Events |
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World Vaccine Congress Washington
27-29 September 2020, Walter E Washington Convention Center, Washington, US
The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
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