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| home > white papers > Sourcing Commercial Drugs for Clinical Trials: US vs. EU Understanding the Differences - Myoderm |
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 WHITE PAPERS |
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Myoderm
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Sourcing Commercial Drugs for Clinical Trials: US vs. EU Understanding the Differences
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Sourcing commercial drugs for clinical trials is a dynamic process. There are many factors to consider: single source or regional sourcing, strategy, price, supply availability, lead times, and documentation are just a few. In the past, there were fewer clinical trials that required commercial drug sourcing, so demand was not as high. Today, the demand for commercial drugs in clinical trials has greatly increased and, as a result, inventory is tighter, orders are monitored more closely by manufacturers, and lead times have increased. This report highlights the key differences in sourcing from the US and EU.
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News and Press Releases |
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PCI Clinical Services Announces New Facility Dedicated to Clinical Trial Returns
Philadelphia, USA – October 15, 2018. Leading international pharmaceutical outsourcing services provider PCI Clinical Services (PCI) has announced the completion of a dedicated Returns Management facility at its Clinical Services Center of Excellence at Bridgend, UK. PCI provides a full service Returns Management service for clients, providing visibility and accountability in returning investigational drug product from investigational sites at the conclusion of a clinical study. Returning and reconciling Investigational Medicinal Product (IMP) on completion of a study is a critical part of a Clinical trial and can require complex reverse logistics. Trial outcomes can be impacted if Returns are not processed efficiently and precisely.
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White Papers |
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Orthogonal Approaches for the Analysis of Protein Sequence
Ludger Ltd
One of the most important classes of biopharmaceuticals is monoclonal antibodies. They are expressed from living cells, and are consequently subject to complex biochemical pathways. Not all of these routes are fully understood, and many are sensitive to the subtlest of environmental changes. Changes such as these can affect the final biopharmaceutical sequence, structure and post-translational modifications, not to mention any changes that may occur during further purification. This often means that the final product from one batch may be different from the last in another batch. Each batch is a complicated mix of similar molecules, and analysis of the degree of batch-to-batch variation is therefore very important to the establishment of the drug's safety for medicinal use and patient administration.
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Industry Events |
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14th Annual Biomarkers Congress
21-22 February 2019, Manchester Central Convention Complex, UK
Oxford Global is proud to present for the 14th year our
flagship Biomarkers Congress, taking place 21 – 22 February
2019 in Manchester, UK. An updated programme ensures you will benefit
from talks on the latest strategies and technologies impacting growth in
the biomarker industry.
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