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| home > white papers > Analysis of Biopharmaceuticals to Conform to ICHQ6B - RSSL |
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 WHITE PAPERS |
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RSSL
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+44 (0)118 918 4024
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http://www.rssl.com
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University of Reading, Whiteknights Rd, Reading, West Berkshire RG6 6LA
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Analysis of Biopharmaceuticals to Conform to ICHQ6B
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Worldwide, the pharmaceuticals market is anticipated to grow from more
than USD 782 billion in 2011 to approach a value of just over USD 971
billion by the end of 2016, registering a CAGR of over 24%. In 2010 the
average medicines expenditure per person within the UK was £271, and
this is expected to increase with the ageing population. A significant
and increasing proportion of these sales are protein-based
biotherapeutics or biomolecules. Currently, these account for 19% of the
total market, and are growing at twice the rate of traditional small
molecule pharmaceuticals. It is predicted that close to 50% of the top
100 pharmaceutical products will be biomolecules by 2016. By far the
largest segment of the biopharmaceutical market is the monoclonal
antibody (MAb) with an estimated share of 25.6%, which corresponds to
USD 51.1 billion.
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News and Press Releases |
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ACRO Releases Diversity and Inclusion Principles Statement in Support of More Diverse Clinical Trials
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White Papers |
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PhlexEarchive: The Right Solution for Electronic Archiving of TMF Content
Phlexglobal Ltd
Many sponsor organizations have already recognized the value of moving from paper to electronic Trial Master Files (eTMFs). But few sponsors have taken a more holistic approach to the TMF lifecycle and looked at the entire process from study start-up through archiving of the TMF in electronic format, also known as e-archiving. The recurring value of managing, tracking, maintaining and accessing electronic files should not stop at the point of archiving. All of the challenges of managing an active paper TMF carry through to a paper archive. All of the benefits of an electronic TMF also carry through to the electronic archive.
As companies look to move their compliance assets to secure, long-term storage, it is important to consider ongoing compliance requirements, security, accessibility, efficiency and costs of archiving TMF content in a digital format.
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