Description

Process improvement has been a dominant movement in many manufacturing industries in the last two decades. The pharmaceutical and biotechnology companies do not broadly recognize the integration of process reengineering along with clinical development in term to break through improvement of business performance. Although this phenomenon is interdisciplinary, its internal structure and the nature of its interactions with other disciplines in clinical development have not been studied in depth. This research analyzed the empirical data based on descriptive statistics on performing variability testing, correlation and predictive analysis. Four major constructs were investigated to test the premise that pharmaceutical and biotechnology companies, which integrate their clinical trial technology with eorkfloe changes by integrating processes into overall clinical development methods will expediate in time to market for new drugs. Historical review of the corporate filings extracted and paired with the survey results were used to predict the implications for business performance of reducing clinical trial delays and elapsed time.