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Business Issues That Affect Clinical Program Planning

Originally Published MX September/October 2003


The scope and shape of a clinical research program should match the medtech company's goals and objectives. The following five key aspects of business strategy should be taken into account in drafting program plans, particularly in the areas of staffing, scheduling, budgeting, and regulatory preparedness.

Funding. One key factor is the extent to which clinical program funding is driven by milestones.
Milestone-driven funding might call for tightened timelines and therefore necessitate strategic rethinking. Ways to accelerate a clinical trial include outsourcing in order to expedite certain processes or--to focus on the end rather than the means--switching to a more narrowly targeted indicated use of the device.

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