Prospects of Outsourcing Clinical Research Projects

Prospects of Outsourcing clinical enquiry ProjectsA STUDY OF OUTSOURCING CLINICAL explore PROJECTS TO ASIAN COUNTRIES (INDIA) ITS GROWTH AND FUTURE PROSPECTSABSTRACTOutsourcing is increasingly becoming a trend inside the clinical interrogation effort. The pharmaceutic and biotechnological spend on unwrapsourcing was estimated to be $48 million in the year 2008 and is expected to increase to $48 million by 2010 Bloch et al, 2006. The concept of outsourcing for the maturement and global studies on new drugs has become widely accepted in the pharmaceutical industry due to its monetary value and uncertainty. India is going to be the most preferred location for contract pharma enquiry and letment due to its huge treatment nave population, human resources, adept skills, adoption/amendment/implementation of rules/laws by regulatory originities, and changing economic environment. But still miles to go to fulfil the pre-requi posts to ensure Indias success. In spite of all the pitfa lls, the field is ambitious and optimist to attract multinational pharmaceutical companies to conduct their clinical trials in India.The inquiry methodological analysis is done mixing the quantitative and qualitative methods as explained by Creswell (Creswell, J. W., 2003). The questionnaires intentional for collecting data had open-and-closed ended questions to obtain both quantitative and qualitative data for the analysis. An all-embracing books review of existing trend of outsourcing clinical query endure was carried out.Six interviews were conducted two interviews to gain an makeing of the routine and the activities outsourced by the pharmaceutical industry, benefits and risks involve in outsourcing, why Indian waneting atomic number 18 considered better to outsource the clinical inquiry switchs and four interviews to evaluate the strategies employed by the ambit in outrank to improve the kinship with key clients.The master(a) conclusion from this study is th at outsourcing is a necessity within the clinical look industry. The study concluded that the many pharmaceuticals from UK be outsourcing their clinical explore mainly to Asiatic countries for fast, cost effective and quality results. The study concluded that the relationship between the client and the compass is the key element for the future of outsourcing clinical look projects.Chapter 1- entry and Background1 INTRODUCTIONOutsourcing allows companies to reduce costs, benefits consumers with lower cost goods and advantages, and causes economic expansion that reduces unemployment, and increases productivity and job creation. Elder, 2009According to the Ameri potbelly heritage dictionary outsourcing is delimitate as the procurement of services or products from an outside supplier or manufacturer in post to cut costs Amiti, 2004This chapter aims to understand the rationale crumb this project which is on understanding the bring of outsourcing within the clinical re depend industry.The cost of drug development has been consistently on the rise, which has led to the pharmaceutical industry encountering for new methods for conducting clinical look into Jayshree, 2005. These companies shake also been trying to develop strategies in order to identify and focus on their core competencies McIvor, 2000. This has straight fashion been achieved by the form of outsourcing.Contract research was initially limited to pre-clinical studies and clinical trial services however it now covers a varied range of activities. Jayshree, 2005 Outsourcing and so has become a customary business strategy. Editors, May 2005. As time progresses a number of activities are outsourced to service providers such as Contract look into organic laws (CRO). It has been estimated that there are 1200 organisations which are involved in clinical research these include pharmaceutical and biotechnological in-house clinical forethought, site management organisations (SMOs), academic an d medical centres, toffee-nosed research sites and contract research organisations. These organisations aid in completion of the projects within the stipulated timelines and thereby increase the profit margins of the pharmaceutical companies.In the US, 60% of the clinical research activities were outsourced to CROs, in the year 2001. The CRO market has been growing rapidly ($1 one thousand thousand in 1992 to $8 billion in 2002). This growth is evident not only in terms of revenue generation but also in the number of patients being recruited in clinical trials (7 million in 1992 to 20 million in 2001). Therefore there is an increasing demand in the pharmaceutical industry for outsourcing activities to these service providers. Jayshree, 2005In order to meet the project requirements and timelines the pharmaceutical companies attempt to select the best service provider from several CROs. There is an intense competition between these organisations. I.1 illustrates the results of a sur vey conducted by Contract pharma in 2005 wherein the respondents have graded the various characteristics they expect from a CRO in terms of very important and / or important.1.2 RESEARCH TITLEA study of outsourcing clinical research project to Asiatic countries (India), its growth future prospects1.3 RESEARCH BACKGROUNDAs time progresses a number of activities are outsourced to service providers such as Contract Research Organisations (CRO). It has been estimated that there are 1200 organisations which are involved in clinical research these include pharmaceutical and biotechnological in-house clinical management, site management organisations (SMOs), academic and medical centres, private research sites and contract research organisations. These organisations aid in completion of the projects within the stipulated timelines and thereby increase the profit margins of the pharmaceutical companies.In the US, 60% of the clinical research activities were outsourced to CROs, in the yea r 2001. The CRO market has been growing rapidly ($1 billion in 1992 to $8 billion in 2002). This growth is evident not only in terms of revenue generation but also in the number of patients being recruited in clinical trials (7 million in 1992 to 20 million in 2001). Therefore there is an increasing demand in the pharmaceutical industry for outsourcing activities to these service providers. Jayshree, 2005Clinical trials are designed to help us specify out how to give a new treatment safely and effectively to people. With escalating pressure on research and development (RD) cost-containment across the global pharmaceutical industry, there is increased focus on reducing the cost of clinical development. The additional conundrum of delayed development is also affecting new drug introductions, losing incremental revenues. This dual challenge of accelerating clinical development and reducing costs has forced major pharma companies to look at alternative destinations for sourcing patien ts for their global studies. Exploration on these lines guides pharma industry to take interest in the countries like Latin America, Eastern Europe and Asia. Amongst Asiatic countries, India stands out prominently due to its huge treatment-nave patients population, English speaking doctors and a large pharmaceutical presence that has dominated the world market due to punk generics. As the multinational drug companies in the United States and Western Europe look east to outsource research and clinical trial activities, countries such as India get out gain proficiency and expertise, assisting its move from generic and speciality contract manufacturing to innovative drug discovery and development in its induce right, setting the s bakshish for increased global competition. Unknown, websitehttp//www.cyfuture.com/history-ofoutsourcing.htm.India has emerged as a grueling base for clinical trials in recent times. Due to the multitude of benefits it offers, the country is fast growing as a centre of conducting clinical trials for many international companies. India, with its huge patient base, low cost advantage, completion of cilia trial on time, improving infrastructure, and with a strong government support is witnessing a double digit growth in its clinical trial market. All major pharmaceutical companies and Clinical Research Organisation (CROs) have already started conducting their clinical trials in India, and with improving infrastructure, industry friendly regulations and trained workforce, the growth is only likely to increase in future.1.4 RATIONALE FOR chosen TOPICI decided to do my research on outsourcing because my personal interest and also clinical research outsourcing became the most important factor in the economic growth of many developing countries. I strongly believe that this paper provide some good literature along with some organisational evidences which willing be beneficial to other pharmaceutical industry to outsource their clinical trials to India.Further as I have chosen my area as a clinical research outsourcing from European countries to many developing Asian countries along with the risk involvement in it so I will be collecting theories and info from pharmaceutical companies which will provide some evidence to the topic. In addition to the theories, I will be interviewing the mangers of pharmaceutical companies to find out their opinion and on that basis I will further review my topic.Also my personal interest in this topic is that I have worked in the clinical research industry for around 3.5 years. I know many of the processes and whole flow of the study completion. I have worked in CRO for top pharma companies like Pfizer and GlaxoSmithKline so I know all the appreciations of clinical research its importance, criticality and confidentiality. Also by working on this thesis I will get to know UK pharmaceutical market and how they carry out their clinical research. It will definitely help me in my job s earch as I want to work in clinical data management field in UK pharma or CRO.1.5 RESEARCH QUESTIONSThey are a core to structure, focus and direct the talk and to reconcile the objectives with the primary research.(I need your inputs regarding how to reference this portion of work as I have taken it from your notes)Research is an nonionic and systematic way of finding answers to questions. Questions are central to research. If there is no question, then the answer is of no use. Research is focused on relevant, useful, and important questions. Without a question, research has no focus, drive, or purpose.Research questions-1) To understand the UK pharmaceutical/clinical research Industry.2) To define the nature and characteristics of outsourcing3) What is the importance of Clinical Research industry?4) What is the relationship between pharmaceutical industry and CR industry?5) Why outsource clinical research?6) Why outsource clinical research mainly to Asian countries?7) What are t he effects of outsourcing clinical research on a pharmaceutical industry?8) How to improve relationship between pharma and CRO in the process of outsourcing?9) Which elements are most important for relationship between pharma and CRO both now and in future?10) How to manage performance throughout the outsourcing process to improve its future?1.6 RESEARCH AIMS AND OBJECTIVESOutsourcing is a fascinating field which now forms a core component of business within the clinical research industry. This chapter aims to understand the aims and objectives which are intend to be completed during the course of this project.1.6.1 AimTo understand the growth and future prospects in outsourcing of clinical research projects from UK Pharma to Clinical Research Organisation in Asian countries.This research was conducted in order to understand the process of outsourcing within the clinical research industry. This research is mainly based on pharmaceutical companies in UK and Europe who outsources thei r most of the clinical trial work to overseas companies mainly in Asian countries .The actual aim of this research is to find out why there is an increase in outsourcing of clinical trials to Asian countries and what are the future prospects for both pharma companies and CRO where the projects are getting outsourced. This research also talks about what benefits the companies have due to outsourcing its clinical trials to developing countries.1.6.2 ObjectivesThe following are the objectives of the research1. To understand the current scenario of outsourcing within the clinical research industry.2. Analysis of UKs pharmaceutic industries where companies are going for outsourcing3. What are the various reasons behind outsourcing?4. Analysis of Clinical Research Organisations in Asian countries were outsourced jobs get done.5. Overlook on the procedure of outsourcing and the basis on which selection outsource company is being done.6. To identify the risks and benefits involved in outsou rcing from the perspective of a client and service provider.7. To develop a questionnaire in order to establish the internal views of a leading Pharmaceutical (Client) and CRO (service provider) on outsourcing.1.7 THE STRUCTURE OF DISSERTATIONThis paper consists of following chapters which are, oration document structureChapter 1 IntroductionIn chapter 1, an introduction to outsourcing and clinical research industry was given in order to provide the reader a good background of outsourcing and clinical research industry. TheChapter also addresses why UK Pharma companies choose CRO in Asian countries (India) for outsourcing and the relationship between them.Chapter 2 literary works reviewThis chapter provides background learning on the processes of outsourcing as well as gives an overview of outsourcing within the clinical research industry.Chapter 3 A incorporate research methodologyA background on the research methodologies, knowledge claims, research strategies, and data accruem ent was given as the first part of this chapter. The implemented research process and methodology for this research study was explained subsequently. The last part of the chapter addressed the reasonedation process and the objectives achieved through the research study.The creator of this thesis selected a research methodology mixing the quantitative and qualitative methods as explained by Creswell (Creswell, J. W., 2003). The questionnaires designed for collecting data had open-and-closed ended questions to obtain both quantitative and qualitative data for the analysis. An extensive literature review of existing trend of outsourcing clinical research project was carried out.Chapter 4 Company CaseChapter 5 Data Collection and Analysis of the projectSix interview were conducted from the UK Pharma and CRO in India to gain an understanding of the process and the activities outsourced by the pharmaceutical industry, benefits and risks involve in outsourcing, why Indian CRO are conside red better to outsource the clinical research projects and what is the future prospects of outsourcing clinical research by developing good relationship between client and CRO.Chapter 6 Conclusions and RecommendationsThe primary conclusion from this study is that outsourcing is a necessity within in the clinical research industry. The study concluded that the many pharmaceuticals from UK are outsourcing their clinical research to Asian countries for fast, cost effective and quality results. The study also concluded that the relationship between the client and the CRO is the key element for the future of outsourcing clinical research.CHAPTER 3 RESEARCH METHODOLOGY3.1 INTRODUCTIONIn 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 chap ter 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 PROCESSThis 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 bringly the research is to be conducted which is followed by the collection of the data which includes primary and secondary data. After analyzing and rendering this collected data final treat is being written.3.3 NATURE OF RESEARCH PROBLEMConducting 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 process3.3.1 Lack of transparencyAn 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 hence increased the time and effort in the data collection phase in the research proce ss but was overcome with certain limitations.3.3.2 Inadequate referencesThe 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 departments 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.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 METHODResearch 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 cipher 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 DESIGNResearch design is a Science of planning procedures for conduct ing 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 broadly conducted for the topics where hardly any few or nothing to refer for the research worker 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 favorabil ity 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 up1. 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.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 creditworthy for ensuring that deliverables are met in a timely manner.7. Conducting the interviews8. Transcription of the responses obtained during the interviews9. Analysing th e 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 rendition was done in two phases1. Desk Research2. Field Research3.5.1 Desk ResearchThe 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 volume 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. virtually reports were also provided by the Industry Supervisor.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 reportKind of information providedMcKinsey ReportsThese reports provide comprehensive information on issues such as consolidation, licensing, biotechnology pipeline, outsourcing within the industry etc McKinsey company website, accessed on 12 celestial latitude 2009Tufts ReportsStrategic information for drug developers, regulator and academic researchers to help improve the quality of pharmaceutical development, review and utilisation Tufts website, accessed on 15 declension 2009external Biopharmaceutical Association PublicationsThe publications give information on p roduct updates, news and industry trends, these journals have articles on the current issues related to the industry IBPA website, accessed on 20 Dec 2009William Blair Company reportsThese reports provide information on research providers and high quality growth companies. William Blair and Company website, accessed on 22 Dec 2009International Monetary monetary fund reportsThese 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 20093.5.2 Field ResearchThe 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 lineaments of research classified on the basis of type of questioning1. Quantitative research2. Qualitative researchQuantitative 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. 1988Qualitative 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 researchThe 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 Supervis ors, 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 collectionThere 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 companionship 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.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 examine 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 than 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 o utsourcing 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. lone(prenominal) 50 references regarded useful to the research were indexed and documented.3.6.2 Identifying IntervieweesIt 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.The field research was carried out in two phases1. Phase I Preparation of questionnaires2. Phase II Conducting the interviewsPhase I (the conceptualisation 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 sharpen 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 were1. Questionnaire for members belonging to pharmaceutical company.2. Questionnaire for members who are part of CROStructured interviewsTwo 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 questionnaireBoth 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 positive 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 com prehensive 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 outsourcingThis questionnaire was designed to obtain informat