New technologies enable the rapid processing of genetic information, but since gene data isn't associated with specific diseases and diseased tissues, in and of itself it isn't clinically useful. A new breed of start-ups aims to provide both the phenotypic and genotypic sides of the equation by creating databases of patients and patient samples. Still unclear is how much drug firms will pay for disease-associated gene data; genetics firms are taking various approaches to monetizing their databases, from focusing initially on high-value diagnostics to creating true target-discovery businesses, to selling their data along with associated software and services. There are also ethical issues to hammer out. The new companies must take care to protect patients' rights. They must consider the need for explicit consent to use the information collected from patients, especially when they are participating in research whose purpose is as yet undefined.

Despite a history of failed products, start-up companies are looking to reinvent how data from clinical trials is collected and managed. Firms are trying to replace the point solutions of the past with broad software offerings that can take clients from "site to submission."

As the cost and complexity of clinical drug development increases, start-ups are creating new technologies to speed things along. In Part I of our survey, we look at companies adapting computer simulation techniques from industries like aerospace to develop and design clinical trials. The two top simulation companies are thrashing out strategies as they debate adopting product or service business models.