outsourcing model in drug development (Coursework Sample)

Outsourcing Model in Drug Development Student's Name Course Code and Name Professor’s Name Date of Submission Introduction The global pharmaceutical industry had a dire need for market speed and was one of the first users of information technology outsourcing. The pharmaceutical firms have been using the outsourcing method in almost everything in informatics. The market shifts and changes have impacted the pharmacy industry. Emerging practices in the pharmaceutical industry such as mergers and acquisition, in and out licensing, and parallel trade, have triggered the development of new revenue methods. The firms within this industry continue to position themselves by marketing strengths, capital base, and other capabilities. The companies have gone further to form networks that enhance their skills within the global industry. The individual firms have to make a choice between biotech, pharma, and their general models. Making the wrong choice can have adverse effects on the growth of an individual firm (Jones & Minor 2010 p.76). Due to increasing costs involved in research and development, pharmaceutical companies have adopted the method of acquiring contract research organizations better known as CRO. Societies have established departments responsible for outsourcing. Other reasons that have prompted these firms to prefer the outsourcing model include the strict regulations that have been implemented and the quality demanded by the international health bodies (Vidic 2005 p.335). However, these CROs, are only hired after detailed assessment and consultation between the firms. The process of outsourcing the firm poses a challenge to the pharmaceutical company. The criteria for choosing a perfect CRO include: The firm should be well experienced in the field of drug research and development The outsourced organization should be compliant with the standards and quality regulations of the international health agencies The CRO must show the willingness and ability to perform the requested tasks and produce timely results The outsourced firm should have the capacity to generate new ideas that are fundamental to the results of the drug development process Some of the benefits that the businesses derive by contracting CROs include: Cost Efficiencies Saving on staff deductions Savings from refocusing stranded employees Products, consultation, and training costs are also reduced significantly Proactive risk management Increased investor funding Losses from delays are minimized Development expenses are reduced Market Share Increased revenue gains Increase of market stability Improved market expansion Increased drug developments Outsourcing has over the years been used as a strategic method to get rid of the capacity discrepancies and improve access to research practice. The focus has been more on the quality and cost involved in any outsourced projects. Many pharmaceutical firms have significantly invested in the identification of competent outsourcing companies. The CROs provide deliverables of high quality at a real cost (Ying et al. 2015 p.1). Currently, new and more innovative outsourcing models are being developed to replace the historically dominant models used in drug development. Through this transformation, the models become independent of any outside resources. However, the current outsourcing model presents a significant challenge due to the various criteria used to choose the CRO. After the commencement of the project, the company cannot re-initiate the process under whatever circumstances (Baguley 2016 p.9). The level to which the project sponsors are engaged and the details of how to come up with the outsourcing model depend on the individual sponsor. Initial planning and organization of both the design and the implementers are necessary for the welfare of the outsourcing model. Some of the challenges that the outsourcing model overcomes during the drug development process include: Control and coordination of different teams by showing the strategies and the results to be expected for the project Bridging communication gaps experienced during drug development All the views and considerations of the parties involved in the project are used within the model There are better planning and discipline enhancement by participants within the model A high outsourcing model that is well planned is key to the success of the drug development process. A method of practicability and early planning is vital in expressing the program in fixed price/ outcomes desired. The planning and feasibility procedure involve must involve assessment of the development environment, protocol, and detailed evaluation of the deliverables. To reduce fixed and mass costs due to large staff bodies within the pharmaceutical firms will have to lessen the number of employees (Bugley 2016 p.5). As a result, the companies will have to implement the outsourcing model especially during cases of drug development. On the contrary, the process of retrenching workers may lead to loss of internal experts and the adequate surge capacity. The activities to be outsourced and those to remain within the firm deserve to be critically analyzed (Vikic 2005 p.334). Within the pharmaceutical industry, technological advancements occur frequently. It is the individual company to decide on the best technology that matches their needs. These innovations, however, are expensive and complicated for a firm to implement. The skills and expertise needed within a short-term are better outsourced. It is the com...