The Merck Internal Contract Research Organization Project

Abstract

Periodic reevaluation of human and financial resource use efficiency 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 efficiently, may better identify procedures or useful refinements to current procedures than formalized ‘continuous improvement’ activities. An internal Merck contract research organization (mICRO) 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 identified in the contract. A key component of the mICRO activity was identifying and trying out different ideas for improving efficiency in data processing and analysis and in interacting with CROs.

The key project milestone dates were met, and the final 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 customer. 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 CRO's needs present opportunities for improving the efficiency of interactions with CROs.