Agile Transformation in Clinical Research

Abstract

We need well designed clinical trials in order to manage different health issues and deliver quality vaccines and drugs to patients. The whole process starts with the phase I of the trial, followed by phases II and III, after which the documentation is presented to the regulatory body, which reviews the data presented, going into the phase IV if required. The process ends with a license to market being issued. Trials are expensive, time consuming and with uncertain outcomes. The old ways of managing clinical trials do not give satisfactory results any more. It seems that the change is needed more than ever before. Clinical research organizations that manage clinical trials, being a part of a highly innovative industry, need innovation themselves. They need to adapt in order to stay competitive. In this paper, it is presented, according to the literature review, that a possible way to undergo adaptation is through agile transformation.

Keywords

• adaptive clinical trials
• agile transformation