Biomedical Field

The Biomedical field is booming, and Tools (databases and software to analyze a biomedical problem) rank number one (over medical devices, heath care services, diagnostics, and therapeutics) for biomedical venture capital funding. We--Daniel Leprince, Preeti Tikekar, Fan Shen, Vijay Patel, Krishna Shroff, and Thomas Albert--therefore establish Berkeley Medical Systems™ to satisfy with state-of-the-art software (PharmaForms™ for "digital reliability in clinical trials"™), hardware, and networking technologies the critical demand for accelerated time-to-market of new pharmaceutical therapies that address such terminal ailments as malignant cancer tumors.

The Food and Drug Administration (FDA), a regulatory agency within the United States Department of Heath and Human Services, oversees the process by which a pharmaceutical company (drug therapy sponsor) brings a new medication to market. The journey from laboratory discovery to routine prescription can take over 15 years and cost up to three hundred million dollars. "Each one day delay in a 12-year testing cycle can cost the sponsor more than $1 million."

Our solution, PharmaForms™, address the Clinical Research pha

We have explained the current process of data management in clinical trials, and seen how two alternative systems address, to varying degrees, shortcomings inherent in paper-intensive traditional (or legacy) operations. We believe the design we show provides a detailed feasibility study, and subject to management approval, should prove itself in initial prototyping and usability tests as warranted for the attainment of organizational goals.

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References

$532 million in 1997 in Silicon Valley alone ("Expertise Critical in Daring Field of Biotech Investing", Scott Herhold, San Jose Mercury News, Sunday, May 17, 1998, pp. 1D., 4D.

"NTC: Oracle Clinical Helps Get New Drugs to Market", Oracle Magazine, March/April 1998, p. 76., and

Information Technology for Management: Improving Quality and Products, Efraim Turban, Ephraim McLean and James Wetherbe (New York: John Wiley & Sons, 1996), p. 19.

"Guidance for Industry: Computerized Systems Used in Clinical Trials", draft of June 18, 1997, U.S. Department of Heath and Human Services, Food and Drug Administration.

http://www.datafax.com - provides fax (rather than digital data) solutions for forms

http://www.oracle.com - provides back end databases as well as the Oracle Clinical application for managing aspects of clinical studies

http://www.sas.com - provides powerful statistical