Process Intelligence: Using Internet Technology to Improve Effective Drug Trial Throughput
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PROCESS INTELLIGENCE: USING INTERNET TECHNOLOGY TO IMPROVE EFFECTIVE DRUG TRIAL THROUGHPUT PHILIPJ. HOLT Vice President, Life Sciences
JANE LIGHT Principal Consultant, e-Solutions Integic Corporation, Chantilly, Virginia
A basic challenge in drug development and clinical trial is the need to achieve throughput
across numerous concurrent projects. Each project may operate under unique conditions and present numerous management challenges that cross organizational boundaries, This issue goes beyond complexity. Management in this environment requires a sort of organizational and operational calculus for controlling and understanding large volumes of clinical data gathered to serve project momentum leading, ideally, to a new drug application. In a traditional model, data are sampled and analyzed through various reporting and representation techniques as business or operational processes generate them. This yields indicators on which some decision can be based. “Business intelligence” is a phrase commonly identified with these methodologies. In the pharmaceutical industry, common business intelligence models offer only a partial solution. This paper outlines a more comprehensive methodology based on “process intelligence. ” Process intelligence represents an understanding of key business data in the context of its relationship to strategy, organizational priorities, and work process momentum. Organizations exercising process intelligence are flexibly adaptive and oriented toward maximizing business throughput and quality. Several attributes identify process intelligence: integration, aggregation, transformation, communication, and orchestration. Each of these attributes is described and analyzed in this paper. Key Words: Process intelligence; Clinical trial;Integration;Aggregation; Transformation; Communication; Orchestration;Case report form; Infrastructure; Internet
INTRODUCTION PHARMACEUTICAL AND biotechnology organizations struggle to balance matters of strategy and value against specific, unpredictable competitive and regulatory pressures. With average development costs for a new drug currently running about $30,000 per day and rising by 10%to 12%every year Reprint address: Philip J. Holt, Integic Corporation, 14585 Avion Parkway, Chantilly. VA 20151.
(l), and development cycle times ranging from about 3 to more than 12 years, the economic consequences of even small actions can be significant. In some cases, even an individual trial can have a dramatic effect on a company’s profitability and general financia1 health. Given research that shows each day of delay to market can cost from $1 to $13 million in sales (l), the ability for a company to achieve consistent results is crucial to the organization’s effectifWless. As modern markets begin to press toward higher
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Philip J. Holt and Jane Light
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levels of performance and even to build-toorder delivery, pharmaceutical and biotechnology companie
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