Our Approach:

"If you do not know where you are going, any road will do."

The first step for any project - whether overt or covert - is a GAP assessment. Very simply it is a definition of:

1. Where to you want to go?

It is surprising how clear a goal can be to individuals, but how unclear it can be to an organization. It is not unusual to find that there is not a shared objective and that an organization cannot reach agreement on what to do because different folks are trying to solve different problems. It is imperative that the organization have a clear articulated goal that everyone understands. Often, what appears to be a complex problem becomes much simpler once there is clear agreement on the objective. In drug development, this often translates to a target package insert. Not only does this help focus the organization it greatly facilitates focused and high quality advice from the regulatory agencies.

2. Where are you now?

It is important that the starting point be clear and fact based. Problems that are not identified cannot be solved, and like in the old cowboy movies, 'they' will get you at the pass.

3. How do you go from '2' to '1'?

There are very simply many ways to get to Rome but some are more lengthy and expensive than others. It is also imperative that everyone gets to the finish line at nearly the same time. The omission of a stakeholder can at best delay a project and at worst can totally derail it. The road to success must be fully vetted to both ensure the viability of the plan, but more importantly, to ensure that all stakeholders are fully aligned.