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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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Sustainability, plastics and Brexit: Keynote speakers set to inspire at PPMA Total Show 2019
Experts from IKEA, the British Plastics Federation and The Sunday Times
to create a forum for education, knowledge-sharing and debate
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White Papers |
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Planning the Execution of a Viral Clearance Study
Eurofins BioPharma Product Testing
Viral clearance studies are a necessary component of any regulatory submission for clinical trials or commercial product approval for all biopharmaceutical products. These studies are performed to evaluate the capability of the purification process to remove or inactivate viruses that could potentially contaminate the starting material. They are complex studies that require substantial financial and personnel resources, as well as specialized scientific expertise to perform. As such, viral clearance studies are often performed at a qualified contract testing laboratory rather than in-house. When multiple parties are involved in this process, clear communication and a comprehensive understanding of the approach and timeline is critical.
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Industry Events |
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The Universe of Pre-filled Syringes and Injection Devices
22-23 October 2019, The Swedish Exhibition & Congress Centre Gothia Towers Hotel
PDA’s Universe of Pre-filled Syringes and Injection
Devices has become the must-attend meeting for everyone
working in the field, and is now the world’s largest conference on this subject
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