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Moving Through Clinical Phases II and III

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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By Philip Guard, Vice-President of European Operations at Clinimetrics Research Associates Inc

Philip Guard has been in the pharmaceutical and biotech industry for over 16 years. Four years as a practicing veterinarian was followed by four years at Glaxo Animal Health.

He then joined Cortecs, a UK biopharmaceutical company (now Provalis), where he established both the clinical research and the project management groups and developed them into directorates within the company. His direct experience in clinical research covers a broad spectrum including therapeutics, biologicals and diagnostics. Philip joined Clinimetrics in 1999.

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