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Item Open Access A management model for a pharmaceutical contract research organization(University of the Free State, 04-May) Jacobs, Yvonne Leonie; Lazenby, A. A.English: Competitive success for a Contract Research Organization (CRO) entails unlimited process improvement to sustain excellence. Chapter One describes the generic business environment CROs operated in which customers dictate the pace of competition through asking for higher standards of quality, speedy delivery, reliability, and lower prices, as markets are becoming increasingly saturated. Opportunities for market growth and maintaining market share, are testing experiences for all CROs. This imposes the tenets of theories and models on CROs so as to understand the critical factors that have a statistically significant effect on their bottom-line figures. CROs need to take note of causal factors drivin g time and costs, even at the height of their success. Therefore, Chapters Two and Three present informative writings on the tenets of best-practices and activity-based management, because best-in-class principles must be reviewed to contemplate which risks to take; which new ideas to implement; which critical factors will drive success, and which will challenge the myths distinctive to the contract research environment. Informative writings, documented as background information, were used to evaluate the results presented in Chapter Five. During the construction of a model for a CRO in the final Chapter, an attempt is made to explain phenomena experienced in everyday life and to discern aspects necessary to sustain competitive success in contract research. For the purpose of this research a model is defined as a set of statements that make explanatory or causal claims about reality, statements that aim to represent everyday phenomena as accurately as possible, and simplify our understanding of the CRO business environment. This research is aimed at developing a management model to explain the particular phenomena applicable to a pharmaceutical CRO and can be classified as an empirical study, analyzing existing primary and numerical data, gathered from a case study. Although management models are well described in literature, this research adds value to an aspect still to be researched, i.e. a management model comprising the most applicable best-practices for a pharmaceutical CRO. Because throughput time is of utmost importance in clinical drug research programs and because time consequently generates costs, an activity-based methodology is considered the best-in-class information tool to gather the necessary data for the calculation of time and cost factors for a CRO. The results presented in Chapter Five, analyzed with a statistical linear regression model using univariate and multivariate analyses to discern which variables have a statistically relevant effect on time and cost factors, were used to formulate the management model in Chapter Six. The productivity model presented shows that if the productivity of the operational divisions imitates the output of the most productive division, the profit can almost be doubled, or conversely, the same profit can be maintained but, with a reduction in the number of full time employees. This holds win-win benefits for the company and the customer, especially if cost can be used as leverage in a competitive market. Pricing is a complex instrument because of the two-sided conflict and competitive nature of the buyer -seller relationship where the one’s gains are the other’s loss. The researcher evaluated time, costs and pricing to make pricing a win-win element through which improved throughput efficacy can provide greater customer value and higher profits to the shareholder. Secrecy agreements are signed between CROs and sponsoring companies and therefore project information is the intellectual property of the sponsoring company. This limiting factor inevitably made a case study approach for this research project a necessity. Research information should preferably have been included from different CROs worldwide, and a case study approach may be regarded as not meeting minimal design requirements for comparison. However, a single, well-designed case study can provide a major challenge to informative writings and theory. It can provide new insight into traditional concepts and figments of the imagination, and identify statistically significant cost drivers to sustain the knowledge base to make recommendations on the optimization of resource utilization. As CROs enter foreign markets, global harmonization of clinical trial standards serve to provide uniformity in processes in trial execution. Guidelines reach beyond the sponsoring country to regulate quality and ensure uniformity of trials globally. Thus, the results obtained from FARMOVS-PAREXEL case studies can be extrapolated to other CROs and the model formulated, as a result of global uniformity enforced by regulations universally applicable to CROs. The project was important because in the quest for developing new drugs, CROs compete inter alia as providers of choice on timelines and price. The interpretation of the results emphasized that factors traditionally perceived as cost drivers, may not have statistically significant effect on time or cost factors. The synergy between techniques applied from the theoretical fields of accounting and project management, i.e. to quantify and optimize resource ut ilization, provided the information to formulate a unique management model for a CRO. The lack of outcome based research results, from a management perspective, on resource consumption during the execution of bioavailability studies, emphasizes the importance of this research project. The research results indisputably prove that concepts and traditions need to be tested with a statistical linear regression and productivity model as the core logic of a management model for a CRO. The results conclusively indicate that a management model with a customer focus for a pharmaceutical CRO is a necessity to align financial performance measures, which are pivotal in the alliance with the customer and shareholder.