The Merck Internal Contract Research Organization Project
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Drug Information Journal,Vol. 34. pp. 433-445. 2000 Printed in the USA. All righfs reserved.
THE MERCK INTERNAL CONTRACT RESEARCH ORGANIZATION PROJECT A. LAWRENCE GOULD,PHD Senior Director, Scientific Staff
ADAMB. POLIS,MSc Senior Statistician
CHARLESL. BERND,BA Director, Data Coordination (Retired) Merck Research Laboratories, West Point, Pennsylvania
Periodic reevaluation of h u m n and financial resource use eficiency in clinical drug development is essential to continued profitability. Starting with a clean slate, knowing what needs to be done, and knowing that it needs to be done effciently, m a y better identify procedures or useful refinements to current procedures than formalized ‘continuous improvement’ activities. An internal Merck contract research organization (mICR0) was created to function as an independent entity whose objective was to bid on and execute a data processing and analysis job at a profit and at an acceptable quality level. mICRO was not obliged to follow Merck practices or procedures or to adhere to Merck standards not identiped in the contract. A key component of the mICR0 activity was identifying and trying out different ideas for improving eficiency in data processing and analysis and in interacting with CROs. The key project milestone dates were met, and thepnal statistical report was delivered on time at a cost one-third less than anticipated. The quality and usefulness of the report and the process by which it was produced were eminently satisfactory to the custome,: Many areas for process improvement were identified. The biggest savings were achieved by reducing rework and review, with no sacrifice in the quality or integrity of the final report. Anticipating and planning for a CROk needs present opportunities for improving the efficiency of interactions with CROs. Key Words:Efficiency; Quality improvement; Personnel development; Profitability; Information processing
INTRODUCTION Motivation The Demands of Clinical Development. Clinical development of pharmaceuticals is a complex, expensive, heavily regulated pro-
Reprint address: A. Lawrence Gould, Merck Research Laboratories. BL 3-2, West Point, PA 19486. E-mail: [email protected].
cess. An enormous amount of information must be obtained and processed with careful attention to completeness and accuracy, and analyzed according to specified plans. Reports describing the results of the trials must be written, completely and clearly relating the results of the analyses to the clinical objectives laid out in the protocols. The efforts of many people with many different skills produce a very substantial package of documentation supporting the efficacy and safety
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A. Lawrence Gould, Adam B. Polis, and Charles L. Bernd
of the product for submission to regulatory agencies around the world. Regulatory approval of the package is necessary before the product can be marketed and the pharmaceutical firm can realize income from its sales. The Importance of Eflci
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