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| home > white papers > Driving ROI: The Case for Investing in Contract & Site Regulatory Document Management Services - DrugDev |
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 WHITE PAPERS |
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DrugDev
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Driving ROI: The Case for Investing in Contract & Site Regulatory Document Management Services
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With tight timelines and complicated regulatory documentation requirements, getting a clinical trial up and running quickly is easier said than done. Key milestones can be achieved only after the successful negotiation of clinical trial agreements and completion of essential regulatory documents. Many clinical trials are hindered by inefficient, labor-intensive processes. Prolonged, inefficient activation can hamper investigator satisfaction and, ultimately, have a negative bottom-line impact for sponsors and CROs. In addition, the Sunshine Act is heightening the importance of financial disclosure in clinical trials. Without a robust financial disclosure strategy, sponsors cannot ensure that physician self-reported financial disclosure data are aligned with the payment data being reported through the Sunshine Act, increasing financial and regulatory risk.
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News and Press Releases |
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Charles River to Present Collaborative Methods at Neuroscience 2018
Charles River Laboratories International, Inc. (NYSE: CRL) today
announced that its team of neuroscience drug discovery experts will
present 26 scientific posters, both independently and collaboratively
with clients, at Neuroscience 2018, the 48th annual meeting of the
Society for Neuroscience (SfN). The meeting, which brings together more
than 30,000 researchers from 80 countries, will take place from November
3-7, in San Diego, California.
More info >> |
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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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Partnerships in Clinical Trials Europe 2018
27-29 November 2018, CCIB, Barcelona
Partnerships
in Clinical Trials Europe is back – and bigger than ever.
Europe’s
most complete clinical meeting is bringing together 1000+ of the industry’s
leading experts this November for it’s 17th annual gathering, and
you’re invited!
More info >> |
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