Literature

DATA MANAGEMENT
written by Peg Regan & Christine Ver Straate

To be published in the upcoming book:

EXPEDITING DRUG AND BIOLOGICS DEVELOPMENT: A STRATEGIC APPROACH-3RD EDITION
By Steven E. Linberg Ph.D.

Introduction
As we are all aware, each day that a product is delayed in getting to market can translate into millions of dollars per day in loss of sales and patent opportunity for the drug and biologics companies of today. This fact, along with the level of competition in the market today, demands that every aspect of the clinical research process be examined for potential areas of process improvement.

The role of data management within the clinical research process is often overlooked and over-simplified. Often times it is generalized as "data processing," and therefore reliant on high levels of transactional processing to make improvements to the overall clinical timeline. Those companies truly interested in improving efficiencies and quality, and reducing the cost of the clinical trials process can benefit greatly from fully understanding how process improvements in data management can affect their business.

In keeping with the approach advocated in this book, this chapter will examine the practical application of utilizing an integrated approach that incorporates the use of a multi-disciplinary team and well defined procedures to the data management process from requirements analysis to study start-up through production data management and submission. The overall benefits and key advantages of applying this approach to the data management process will be discussed in relation to reduced cycle time, an increased accuracy and efficiency, and ultimately the overall reduction in time and cost to a successful submission. Anyone working in the clinical development process, specifically within data management, will benefit from incorporating and applying these approaches to their everyday work and practices.

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