Rapid Deployment Approach Through Flexible System Design: Breakthrough in Technology Innovation and Process Optimization for eClinical Trials

Abstract

In the pharmaceutical industry, the pressure on small companies to bring innovative products to market versus large competitors is unprecedented. With the desire to decrease the cost of conducting trials, reducing time to market and improving their competitive edge, smaller biotechs and pharmaceuticals will require inventive strategies for building, designing, and deploying their studies. With the availability of flexible configurable Electronic Data Capture (EDC) systems that come equipped with preconfigured, prepackaged, and standard offerings, for Phase I and II trials, both study design and development time would be radically reduced. With traditional EDC systems requiring 8–12 weeks to configure, flexible systems that offer prepackaged yet modifiable offering to configure would significantly reduce design and development time by over 50 %. However, adopting a flexible technology system alone cannot solve this industry dilemma for speed to market. Well-defined process strategies defined by the pharmaceutical stakeholders are the remaining ingredient to transform a new platform to further reduce costs historically associated to the long lifecycle of clinical trial development. When time to market is critical, the breakthrough of technology innovation and process optimization can streamline and enhance productivity in the eClinical development cycle, data collection, data monitoring, data review, and reporting.

This chapter will show the mapping of the flexibility in an organization and impact on performance. Flexibility Options will be outlined and considered using Flexible system tools. The analysis includes SAP–LAP framework and SAP–LAP models and linkages. This chapter will show how a more flexible pharmaceutical business infrastructure can help an organization cut costs, reduce time to market, increase profits, and, perhaps most importantly, prepare for unpredicted challenges in a rapidly changing industry with the use of adaptive trial design.