We work together with the pharmaceutical industry to develop agents to improve the lives of diabetic patients. It is in our joint interest to identify promising areas for drug development and to streamline the processes leading to approval and marketing of new agents. As the lead investigators in numerous studies which have brought new drugs into common use, we have acquired a unique experience in the processes and pitfalls of drug development.

We understand the critical importance of cleanly designed protocols which capture necessary critical information, without overwhelming the system in extraneous details. We have seen protocols fail due to mistakes in data collection. We have learned the essentials of realistic patient selection criteria. We realize the errors which occur when practical clinical details are overlooked. We have seen the delays in patient enrollment which occur when criteria are too restrictive.

We understand the central role of data collection. We have seen paper based systems give way to remote data entry and then return to paper when computer systems became unmanageable. We have worked with good systems and with bad systems.

We have seen the overwhelming importance of generating investigator commitment. Investigators who believe in a study will overcome any problems which arise and will become enthusiastic spokesmen for development and later marketing of a new agent. We know that the goal of drug development is more than simply obtaining approval. The key to success is to ask the right questions during drug development so as to determine the appropriate use of an agent once marketed.

We want to share our experience. Members of our group are willing to consult in the early stages of drug development to help sponsors streamline the process of evaluation and approval. Together, we can provide input across the spectrum of the development, clinical trial performance, approval, and marketing process.