CHAPTER 3 RESEARCH METHODOLOGY

（原文請點擊：英國臨床研究行業的外包研究dissertation）

3.1 INTRODUCTION
 

In the previous chapters I have presented the overall background to the topic and also supportive literature to the outsourcing of clinical research along with relationship building in between CRO and pharma. The main aim of this chapter is to outline the research methodology used for this topic. In this chapter we will provide and discuss the content of the research approach towards the topic and designing of it used throughout the study of it.
 

3.2 RESEARCH PROCESS
 

This is traditional and highly structured view of research process. This model also provides research as neat and orderly process, with one stage leading logically on to the other. As provided in step 1 research topic can be identified as a result of your course, work, job, interest area or general experience. On the basis of research topic in order to narrow down the research area, research problem is defined which focuses on particular research problem with small enough of investigation. Next step is to tell how exactly the research is to be conducted which is followed by the collection of the data which includes primary and secondary data. After analyzing and interpreting this collected data final report is being written.
 

3.3 NATURE OF RESEARCH PROBLEM
 

Conducting research in the real world was a challenge for dissertation due to the lack of a central body/authority to provide information related to pharmaceutical and CRO confidential data regarding outsourcing of clinical research. The followings are some of the key challenges faced during the research process:
 

3.3.1 Lack of transparency
 

An effort was made to address some questions through the questionnaires related to the outsourcing of clinical research and its benefits, the risks you face when you outsource processes to the CRO, the key issues that lead to a loss of business from the clients, and the competencies that differentiate the CRO from its competitors. These questions were either not answered or answered with uncertainties by some respondents. The author has to take out the information through indirect ways of addressing the questions over the interviews conducted with some of the Operational managers and employees in person or through phone interviews. This indeed increased the time and effort in the data collection phase in the research process but was overcome with certain limitations.
 

3.3.2 Inadequate references:
 

The author had struggled to find good references or documents related to outsourcing clinical research, its future and all the other relevant data was offered either through the common portal or the business department's sites. The lack of academic case studies on information security, publications, or white papers was a challenge for the extraction of information in the literature review and data analysis.#p#分頁標題#e#
 

Despite the above challenges, the objectives of the research as mentioned in Section 1.4 were the pillars of the research methodology and the research process was implemented to achieve them.
 

3.4 RESEARCH METHOD
 

Research method tells about the methodologies used for the research topic. The main aim of this method is to discuss and select the appropriate method to achieve the research objectives which also provide the structured and systematic way throughout the process to perform the research.
 

A Research Method is nothing but a way in which the data is arranged to get desired output. It can also be defines as a systematic and orderly approach to the collection and analysis of data. In any research collected or gathered is always called as samples or data, which is raw, specific, untreated, undigested and therefore largely meaningless. The analysis arranges the data in a meaningful manner and resolves research questions. So it is very important to select a correct analysis method on the correct set of data to get accurate results and outputs for the research problem. There are several different analytical methods, which are commonly used in business and management research works. These methods vary according to the nature and scope of the topic and thesis, the sources of data to be used, the purposes of gathering data, the amount of control in obtaining the data, and assumptions to be made in analyzing the data.
 

3.5 RESEARCH DESIGN
 

Research design is a ‘Science of planning procedures for conducting studies so as to get the most valid findings' (Vogt, 1993, P.196). Research design will give you detailed plan and guide about focus of your research. Research design is a strategic research approach which is adopted to answer the research questions. The research approaches are classified as exploratory, descriptive or analytical research. Exploratory research is generally conducted for the topics where hardly any few or nothing to refer for the researcher in terms of work done by previous researcher. Researcher conducts the exploratory research for three main purposes a) diagnosing a situation, b) Screening alternatives, C) Discovering new ideas.(Zikmund,200). In general exploratory research is meaningful in any kind of situation where there is not a exact understanding in order to proceed with research (malhotra, 2004).
 

Research conducted for this project was largely exploratory, which involved brand equity research; a research wherein the researcher determines the favorability of a particular brand among its customers [Trochim, W.M.K, 2006].
 

In order to fulfill the aims and objectives set for this project a schedule of tasks to be completed was drawn up:

1. A comprehensive study of article and reports which dealt with basic outsourcing as a concept.

2. A study of articles and reports related to outsourcing within the clinical research industry to provide an insight into the functioning of pharmaceutical companies.#p#分頁標題#e#

3. Evaluation of the information gathered so as to compile a literature review.

4. Preparation of questionnaires as tools to obtain the generic information about outsourcing within a leading pharmaceutical company.

5. Selecting relevant interviewees for conducting the interview.

6. Preparation of questionnaires in order to interview key people within the organisation who were responsible for ensuring that deliverables are met in a timely manner.

7. Conducting the interviews

8. Transcription of the responses obtained during the interviews

9. Analysing the responses obtained and generating the results.

10. Conclusions and recommendations from the results obtained.
 

These tasks required a comprehensive collection of information from various sources. The collection of data for analysis and interpretation was done in two phases:
 

1. Desk Research

2. Field Research

3.5.1 Desk Research
 

The desk research comprised a comprehensive and extensive literature review in order to gain a thorough understanding of the industry, outsourcing. This took place during the first four weeks of the project. The reading material covered a range of internet articles and industrial reports. The majority of the articles were found by using internet research. This method of research involved the extensive use of the Internet especially the World Wide Web [Berry, D. M. (2004)]. The search engines used to look for information included Google, Yahoo, MSN, Google Scholar and the UWIC library search hub. Some reports were also provided by the Industry Supervisor.#p#分頁標題#e#
 

The articles were read and the information which was relevant to the project aims was reviewed and included in the literature review which forms the second chapter of the thesis. Some of the well known reports such as the Tufts reports and a report by Alison Sahoo, (2006) on Pharmaceutical Outsourcing Strategies did not only provide very good background information but also provided a plethora of information on outsourcing.
 

Name of report
 

Kind of information provided
 

McKinsey Reports
 

These reports provide comprehensive information on issues such as consolidation, licensing, biotechnology pipeline, outsourcing within the industry etc [McKinsey & company website, accessed on 12 Dec 2009]
 

Tufts Reports
 

Strategic information for drug developers, regulator and academic researchers to help improve the quality of pharmaceutical development, review and utilisation [Tufts website, accessed on 15 Dec 2009]
 

International Biopharmaceutical Association Publications
 

The publications give information on product updates, news and industry trends, these journals have articles on the current issues related to the industry [IBPA website, accessed on 20 Dec 2009]#p#分頁標題#e#
 

William Blair & Company reports
 

These reports provide information on research providers and high quality growth companies. [William Blair and Company website, accessed on 22 Dec 2009]
 

International Monetary Fund reports
 

These reports provide information on high quality research and publish articles by a variety of guests on a number of topics [IMF Staff Papers, accessed on 27 Dec 2009]
 

3.5.2 Field Research
 

The research on the subject of outsourcing included the construction of questionnaires and interviewing internal members of a leading CRO in order to fulfil the aim of the project. There are two types of research classified on the basis of type of questioning:
 

1. Quantitative research
 

2. Qualitative research
 

Quantitative research is research which uses a combination of inferential statistics and descriptive statistics as tools to analyze data and draw conclusions. It involves random sampling techniques to enable valid and credible sampling from a particular population.
 

This kind of market research includes surveys and questionnaires which express a statistically significant result. [Bradburn et. Al. 1988]
 

Qualitative research, on the other hand, generally precedes the quantitative research. It aids in understanding a problem, setting up a hypothesis and determining the route to be taken for the quantitative research. This type of research is expensive and does not progress as rapidly as its counterpart. The number of respondents in this type of research is few and therefore the results of such a research cannot be extrapolated to the entire population [Malhotra, 2006].
 

The essential guide to doing research
 

The research carried out in this study was qualitative in nature and hence did not generate a large amount of statistical information.
 

It was decided, with the consent of the University and the Industry Supervisors, that the aims and objectives of the project could be fulfilled by interviewing relevant people within the CRO itself.
 

There were four interviews, in total, which were conducted. Two interviews were conducted from the members which belong to pharmaceutical company and other two were conducted from CRO, which is service provider for this pharmaceutical company.
 

3.6 Data collection
 

There are two main types of data collection primary data collection and secondary data collection.
 

Primary data is the one which can be obtained by researcher directly, by observation or measurement of phenomenon in a real world without any disturbance of third party involvement. (walliman,2005). In every case researcher is answerable for his sources and should be able to argue in defense of quality of his sources.#p#分頁標題#e#
 

In secondary data the information is subjected to the source of reference. The main difference between primary and secondary data is, Primary data is originated by researcher for specific purpose of addressing the problem where as secondary data have been already collected for the purpose of other than problem (Malhotra, 2005).
 

In the data collection process, both questionnaires and interviewing methods were adopted. The interview data were analyzed using the immersion approach (Robson, C., 2002)
 

The questionnaires were designed to include open ended questions and closed ended questions in order to give the participants the flexibility to add more comments and points and not be restricted to the answers provided for any question (Creswell, J. W., 2003).
 

3.6.1 Review of secondary resources:
 

* Related research papers, journals, industrial white papers, and surveys were researched, collected, indexed, and reviewed by the author. The objective of this step was to have a good repository of all journals and conference proceeds addressing the topic of outsourcing, different methods of outsourcing, clinical research industry, pharmaceutical industry , and increase in the outsourcing of CRO projects to developing countries like India , china etc.
 

* During the course of the research, the author had either read or skimmed through more than 50 journals, whitepapers, conference proceedings, and books. Only 50 references regarded useful to the research were indexed and documented.
 

3.6.2 Identifying Interviewees:
 

It was of paramount importance to select the right people to interview from a plethora of people, each skilled in their own field. With the intention of obtaining the maximum amount of information from the interviewees about outsourcing within the clinical research industry, people who were crucial to increasing the business opportunities for the leading pharmaceutical were chosen for these interviews. These people form a bridge between the top pharmaceutical companies and the CRO; hence it was decided that they were the best in the field of outsourcing within the CRO and therefore were selected for the interview. The questionnaires for the interviews were prepared accordingly.#p#分頁標題#e#
 

The field research was carried out in two phases:
 

1. Phase I: Preparation of questionnaires
 

2. Phase II: Conducting the interviews
 

Phase I (the preparation of the questionnaire) required the author of this thesis to have an appreciation of the challenges of the industry and the current state of the art with respect to outsourcing in order to be able to target the questions in the most appropriate manner. There were two different questionnaires employed and these were directed at two different business activities that could be outsourced. These were:#p#分頁標題#e#
 

1. Questionnaire for members belonging to pharmaceutical company.
 

2. Questionnaire for members who are part of CRO
 

Structured interviews:
 

Two questionnaires (A and B) were created and were sent to Pharmaceutical Company (Pharma) and the CRO (Clinical Research organisation) respectively with specific and direct questions related to the areas of research interest. A preliminary interview with the head of Outsourcing Department in the pharmaceutical company was conducted to explain the purpose of the research and seek his opinion on the questionnaires and their objectives. Some of the heads of the departments did not have the chance to fill questionnaire and requested the author to fill them during their interviews.
 

Mailed/Online questionnaire
 

Both questionnaires A & B were sent to the appropriate participants. The participants were invited based on their management involvement and based on their strong background on the outsourcing issues. The questionnaires were sent via email to them and the feedbacks were received through email.
 

Both questionnaires A and B were developed as an output of this phase with different sets of questions addressed to the two categories of respondents (pharmaceutical company and Clinical Research Organisation). The questionnaires were sent and assistance offered to clarify the questionnaires questions if needed.
 

The background information was obtained by a comprehensive study of the available literature and that has been reported in Chapter III. This chapter aims to report the results obtained during the interviews which were conducted as part of the research.
 

3.6.3 Questionnaire for members belonging to pharmaceutical company related to outsourcing
 

This questionnaire was designed to obtain information about the kind of support work that the leading pharmaceutical outsources at the moment. This questionnaire is intended for the management team involved in outsourcing of clinical research projects to other CRO's in Asian countries. The purpose of this questionnaire is to have clear understanding of outsourcing process, risk assessment, future prospects and increase in outsourcing to Asian countries.
 

Question Numbers
 

Reasons for including the questions for Questionnaire A
 

Q 1 - Q4
 

These questions were designed to obtain information about the interviewee, his role in the company and the kind of activities the CRO outsourced.
 

Q5 - Q7
 

These questions were aimed at understanding the risks faced by the CRO during the process of outsourcing. These questions also aimed to obtain information about the process of risk assessment.
 

Q8 - Q9#p#分頁標題#e#
 

These questions attempted to obtain information about the process of outsourcing within the CRO and measures that were intended to be taken to improve the process.
 

Q 10 - Q 13
 

These questions were designed to obtain information on outsourcing from companies that did not outsource any activities.
 

3.6.4 Questionnaire for members belonging to CRO related to outsourcing
 

This questionnaire is intended to obtain viewpoints of experienced employees of the CRO in order that an insight into outsourcing from the perspective of a service provider could be reported. The purpose of this questionnaire is to have clear understanding about relationship with client, impact of pricing and globalization on the business inflow, and its future prospects.
 

Question Numbers
 

Reasons for including the questions for Questionnaire A
 

Q 1 - Q4
 

These questions were designed to obtain information about the interviewee, his role in the company and the kind of activities the CRO outsourced.
 

Q5 - Q7
 

These questions were aimed at understanding the risks faced by the CRO during the process of outsourcing. These questions also aimed to obtain information about the process of risk assessment.
 

Q8 - Q9
 

These questions attempted to obtain information about the process of outsourcing within the CRO and measures that were intended to be taken to improve the process.
 

Q 10 - Q 13
 

These questions were designed to obtain information on outsourcing from companies that did not outsource any activities.
 

3.5. Chapter summary
 

The main areas covered in the research methodology chapter are the scientific background of the research methodology, knowledge claims adopted, the implemented research processes, the methods of data collection, and the two type of questionnaires used to to get the understanding of outsourcing clinical research from pharma to Asian CRO. The author used the post-positivism, constructivism, and the pragmatism knowledge claims. The research analysis of the data was using both qualitative and the quantitative research strategies. A research process adapted from Business Research (Collins, & Hussey, 2003). Methodology was followed to achieve the research objectives. The qualitative and quantitative data analyses were applied on the data collected from both questionnaires. The qualitative analysis was mainly to use a combination of inferential statistics and descriptive statistics as tools to analyze data and draw conclusions. Qualitative research, on the other hand, generally precedes the quantitative research. It aids in understanding a problem, setting up a hypothesis and determining the route to be taken for the quantitative research.#p#分頁標題#e#