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European Pharmaceutical Contractor
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This article is not a step-by-step guide to the well-defined stages of clinical development, as there are plenty of excellent texts on the definitions of each phase and all the regulatory requirements and implications. However, it is useful to review the impact of the individuals involved in the team assembled to convert the project to a product.
So let's move beyond the mechanical activities to the thought processes at each stage, the considerations and implications of the decision-making at each step, and how these are communicated to everyone involved.
In an ideal world the end of Phase I is reached with all the preclinical data completed to add to the first human safety and tolerance data. The project is then clearly mapped out through the stages leading to marketing approval for the chosen indication(s), with all the timelines neatly illustrated by whatever project management software is used. And then reality kicks in...
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Industry Events |
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DIA Annual EuroMeeting
26-28 March 2012, Copenhagen, Denmark
The EuroMeeting attracts more than 3,000 professionals from over 50 countries. It brings together professionals from the biopharmaceutical industry, contract service organisations, clinical research, regulatory agencies, health ministries, patients’ organisations and universities. This convergence affords attendees the opportunity to network with professional colleagues from around the world.
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DASGIP Product Catalog 2012 now available for download
The new DASGIP Product Catalogue is now available online. The catalogue offers a user-friendly update on our technology. You will find a comprehensive overview on our portfolio including information on recently launched products such as our Bioprocess Software Suite DASware and the Minibioreactor System DASbox.
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