This Small Business Innovation Research Phase I project will determine the feasibility of developing a series of tools which can be used in the submission of a Computer Assisted New Drug Application (CANDA). The United States Food and Drug Administration (FDA) was created to control the testing and approval of new drugs for marketing to protect individuals from harmful compounds. This process has contributed significantly to the increase to the cost in developing a new drug to between $125 million and $500 million, requiring as many as ten to twelve years before it can be introduced into the market. The implications of reducing this time to market are staggering with regard to the positive impact on the cost and quality of health care to say nothing of the human lives that could be saved. The Lotus Notes software platform will provide the formulation of a user-friendly, efficient software package that will expedite and facilitate the task of submitting CANDAs to the FDA and the analysis of the data by the individual reviewers. As a first step, BIOSOFT believes that the power of Lotus Notes can greatly simplify the development of an electronic Case Report Form (CRF) for use at clinical sites, and the validation and certification of information. In the future, BIOSOFT believes that this electronic CRF will be complemented with electronic lab notebooks to create an extremely powerful basis for a submission to the FDA exceeding current standards and expectations. This approach can become the basis for re-engineering the drug development process, reducing the time to market by as much as 50 percent.
