Pharmaceuticals companies are generally heavily regulated.

It can take years for a new drug to make it to the market because of time for the development phase, highly monitored testing, and final approval by the Food and Drug Administration (FDA). Once the drug is on the market, other companies can try to produce generic drugs that seem to be compatible with the name-brand drug.

Occasionally an approved drug, some years into its life span, gets scrutiny for higher-than-expected side effects. For example, a drug that is effective in lowering cholesterol might also cause the side effect of an increased chance for cataract growth that was not discovered during the initial testing and approval cycle. Data are collected on all aspects of clinical trials and from the marketplace, but some relationships are just harder to find.

Questions

1. Is there a particular systems approach to being able to collect and analyze data from a mountain of data?

2. If you were building a strategic planning system for tracking a drug from proposal through development and testing and into the marketplace, how would you approach it?

3. What requirements might be necessary to build such a system?