Emerging Clinical Trial Locations: Market dynamics and the changing healthcare and regulatory environment

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Emerging Clinical Trial LocationsMarket dynamics and the changing healthcare and regulatory environmentReport OverviewPharma and biotech companies are attempting to combat escalating R&D costs and lengthy clinical trial timelines by improving patient recruitment and the efficiency of clinical trial analysis/reporting. The biopharmaceutical market has recognized the opportunities and advantages that exist by conducting clinical trials in emerging markets. Although these markets offer a number of significant benefits over traditional clinical trial settings, there remain a variety of challenges and problems associated with conducting trials in emerging regions. 'Emerging Clinical Trial Locations' is a report published by Business Insights that provides a comprehensive examination of the clinical trial landscape in emerging countries, with specific focus on China, India, Central and Eastern Europe and Latin America. It identifies the major drivers and barriers to conducting clincial trials in emerging regions and profiles key issues for consideration when selecting a trial site. For each featured region, this report provides an assessment of pharma market dynamics, the heathcare system and CRO-related infrastructure, leading CROs established within the region and the regulatory and legislative frameworks that govern the conduct of clinical trials. Key FindingsRussia is one of the world leaders in patient enrolment - the average patient recruitment rate in 2006 exceeded 4.7 patients per site per month. For some nosologies, this figure is 10 times higher than in Western Europe and the US. The Chinese Clinical Trial Register (CHiCTR) and The Clinical Trials Registry in India (CTRI) have helped to encourage all clinical trials in these regions to be registered before the enrolment of the first participant, and to disclose the mandatory 20 items of the WHO International Clinical Trials Registry Platform (ICTRP) dataset. By the end of May 2009, 895 clinical trials were registered in India. By comparison in 2006, 150 clinical trials had been approved by the Drug Controller of India (DCI). India is able to offer significant cost savings compared with conducting clinical trials in western countries. Phase I trials are approximately 50% cheaper than western equivalents, while Phase II and Phase III are 60% less expensive. The Chinese CRO market was valued at $250m in 2008. The market is expected to grow at a CAGR of 33% over the next four years to reach $791m in 2012. By that time, Chinese CROs will account for an estimated 2.3% of the global CRO market. China's IP protections systems still have a number of serious flaws, despite attempts to conform with international IP protection standards through amendments of the Patent Law and restriction of product approvals by the SFDA. The number of clinical trials in Brazil has increased from 9 in 2000, to 1177 by 2008. In Argentina the number of trials has risen from 6 to 801 over the same period, while Mexico has witnessed an increase from 63 to 2014. The costs of conducting clinical trials in Latin America vary from substantially less expensive than the US to slightly more expensive. In recent trials, the cost per patient for Latin America has varied from savings of 50% to relative cost increases against US per patient costs. The value of the Polish clinical trial market for Phase I to Phase IV clinical trials and bioequivalence studies has been estimated to be worth K167m ($224m) in 2008, having increased in value by 10% from the Use this report to...Assess the viability of key emerging clinical trial locations including China, India, Eastern Europe and Latin America by analyzing each region based on: ' Pharma market dynamics ' Drivers of CRO market growth ' Barriers to CRO market growth ' Healthcare systems and hospital resources ' Related regulation and legislation Examine the phases of the clinical trial process with analysis of clinical trial protocols, rel

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Emerging Clinical Trial Locations: Market dynamics and the changing healthcare and regulatory environment

  1. 1. Find Industry reports, Company profilesReportLinker and Market Statistics >> Get this Report Now by email!Emerging Clinical Trial Locations: Market dynamics and thechanging healthcare and regulatory environmentPublished on June 2009 Report SummaryEmerging Clinical Trial LocationsMarket dynamics and the changing healthcare and regulatory environmentReport OverviewPharma and biotech companies are attempting to combat escalating R&D costs and lengthy clinical trial timelines by improvingpatient recruitment and the efficiency of clinical trial analysis/reporting. The biopharmaceutical market has recognized theopportunities and advantages that exist by conducting clinical trials in emerging markets. Although these markets offer a number ofsignificant benefits over traditional clinical trial settings, there remain a variety of challenges and problems associated with conductingtrials in emerging regions.Emerging Clinical Trial Locations is a report published by Business Insights that provides a comprehensive examination of theclinical trial landscape in emerging countries, with specific focus on China, India, Central and Eastern Europe and Latin America. Itidentifies the major drivers and barriers to conducting clincial trials in emerging regions and profiles key issues for consideration whenselecting a trial site. For each featured region, this report provides an assessment of pharma market dynamics, the heathcare systemand CRO-related infrastructure, leading CROs established within the region and the regulatory and legislative frameworks that governthe conduct of clinical trials.Key FindingsRussia is one of the world leaders in patient enrolment - the average patient recruitment rate in 2006 exceeded 4.7 patients per siteper month. For some nosologies, this figure is 10 times higher than in Western Europe and the US.The Chinese Clinical Trial Register (CHiCTR) and The Clinical Trials Registry in India (CTRI) have helped to encourage all clinicaltrials in these regions to be registered before the enrolment of the first participant, and to disclose the mandatory 20 items of the WHOInternational Clinical Trials Registry Platform (ICTRP) dataset.By the end of May 2009, 895 clinical trials were registered in India. By comparison in 2006, 150 clinical trials had been approved bythe Drug Controller of India (DCI).India is able to offer significant cost savings compared with conducting clinical trials in western countries. Phase I trials areapproximately 50% cheaper than western equivalents, while Phase II and Phase III are 60% less expensive.The Chinese CRO market was valued at $250m in 2008. The market is expected to grow at a CAGR of 33% over the next four yearsto reach $791m in 2012. By that time, Chinese CROs will account for an estimated 2.3% of the global CRO market.Chinas IP protections systems still have a number of serious flaws, despite attempts to conform with international IP protectionstandards through amendments of the Patent Law and restriction of product approvals by the SFDA.Emerging Clinical Trial Locations: Market dynamics and the changing healthcare and regulatory environment Page 1/13
  2. 2. Find Industry reports, Company profilesReportLinker and Market StatisticsThe number of clinical trials in Brazil has increased from 9 in 2000, to 1177 by 2008. In Argentina the number of trials has risen from 6to 801 over the same period, while Mexico has witnessed an increase from 63 to 2014.The costs of conducting clinical trials in Latin America vary from substantially less expensive than the US to slightly more expensive.In recent trials, the cost per patient for Latin America has varied from savings of 50% to relative cost increases against US per patientcosts.The value of the Polish clinical trial market for Phase I to Phase IV clinical trials and bioequivalence studies has been estimated to beworth K167m ($224m) in 2008, having increased in value by 10% from theUse this report to...Assess the viability of key emerging clinical trial locations including China, India, Eastern Europe and Latin America by analyzing eachregion based on: Pharma market dynamics Drivers of CRO market growth Barriers to CRO market growth Healthcare systems and hospital resources Related regulation and legislationExamine the phases of the clinical trial process with analysis of clinical trial protocols, related ethical issues, clinical trial study designand planning, patient identification and recruitment, and the influence of regulatory authorities and agencies.Understand how new technology platforms are enhancing clincial trial effectiveness and identify the issues and challenges associatedwith these innovations.Analyze the major market drivers and barriers for clinical trials in emerging markets with analysis of the key benefits and challengesassociated with trial sites in emerging countries and the key considerations for site selection. Table of ContentTable of ContentsEmerging clinical trial locations - Executive summary 16Introduction 16Conducting clinical trials in emerging markets 17India 18China 19Latin America 20Central and Eastern Europe 21Chapter 1 Introduction 24Summary 24Introduction 25Generic competition 25Intellectual property protection 25Managing regulatory compliance 27Cost containment and government funding restrictions 28Obtaining and maintaining competitive advantage 28Emerging Clinical Trial Locations: Market dynamics and the changing healthcare and regulatory environment Page 2/13
  3. 3. Find Industry reports, Company profilesReportLinker and Market StatisticsRecruitment and retention of a skilled workforce 29Improvement to R&D productivity 30High risks and costs associated with drug development 30Escalating costs of clinical trials 30Global increase in the number of clinical trials conducted 34Longer R&D timelines 34Increased attrition rates during R&D 37Clinical trial study design and planning 38Clinical trial study design 38Clinical trial study protocol 38Clinical trial sponsors 38Identifying and recruiting patients 39Role of CROs 39Information technology and new technology platforms 40Drivers of development 40Advantages associated with EDC 40Advantages of electronic Clinical Trial Management Systems(CTMS) 41Cost saving 42Issues and challenges 42Electronic records and signatures 42Integration and linkage of electronic systems 43Security and confidentiality of patient data 43Chapter 2 Conducting clinical trials in emerging markets 46Summary 46Introduction 47Market drivers 49Rapid recruitment of patients and clinical trial investigators 49Significant cost benefits 51Improving transparency and efficiency of regulatory systems 52Harmonization and standardization of regulatory requirements 53Expansion of CROs 54Conducive hospital infrastructure and healthcare systems 56Enhanced clinical site effectiveness 57Future commercial value 58Key barriers 59Concerns over the clinical trial transparency 60Publication bias 61Selective reporting 62Duplicate publication 62Conflict of interest 62Availability of demographic and epidemiology data 62Critical components concerning capacity building 63Assimilation of individual national regulations and guidelines 66United States 66Japan 67European Union 68Language translation 69Ethical challenges 69Health needs of the population under study 70Emerging Clinical Trial Locations: Market dynamics and the changing healthcare and regulatory environment Page 3/13
  4. 4. Find Industry reports, Company profilesReportLinker and Market StatisticsRespect for potential and enrolled subjects 70Ethical oversight 71Lack of review by institutional review board (IRB) 71Absence of informed consent 72Scientific validity 73Inadequate protection of intellectual property 73Clinical trial logistics 74Import licenses and applications 74Customs regulations 75Storage, handling and distribution 75Selecting an appropriate CRO 76Patient enrolment 79Site selection 80Site activation 80Patient recruitment 80Chapter 3 India 84Summary 84Introduction 85Geographic 85Political 85Economic 85Market dynamics 85Vital statistics 85Population statistics 87Epidemiology and prevalence of major disease 88Pharmaceutical market 89Biotechnology market 92CRO market 94Clinical trial market 97Geographic focus of the Indian clinical research industry 97Market drivers 100Population ethnicity and genetic diversity 100Large complement of trained medical specialists in India 101Significant cost savings 102Government incentives 103Creation of the Clinical Trials Registry India (CTRI) 103Sophisticated logistics and clinical research infrastructure 104Comprehensive IT and IT enabled support (ITES) base 105Key barriers 106Ethical issues 106Lack of experienced investigators 107Inability to detect and monitor ADRs 107Bribery and corruption 107Healthcare 108Healthcare system 108National level 108State level 108Regional level 108District level 109Sub-divisional/Taluka level 110Emerging Clinical Trial Locations: Market dynamics and the changing healthcare and regulatory environment Page 4/13
  5. 5. Find Industry reports, Company profilesReportLinker and Market StatisticsCommunity level 110Primary health centre (PHC) level 110Sub health centre (SHC) level 110Hospital resources 110Regulation and legislation 112Regulatory authorities 112The Ministry of Health and Family Welfare 112Central Drug Standard Control Organization (CDSCO) 115Drug Controller General of India (DCGI) 115Indian Council of Medical Research (ICMR) 116Clinical trial regulation 116Harmonization of the clinical trial approval process 118Legislation 120Patent law and WTO TRIPS 120Schedule Y Drugs and Cosmetics Act and Rule 122Summary of the recent regulatory and legislative changes 123Evolution of the regulatory environment 124Expected improved collaboration: DCGI with international agencies 125Anticipation of approval for early phase studies in India 126Registration and regulation of CROs in India 126Future reform and emphasis on improved pharmacovigilance inIndia 127India to implement an electronic management system 128Outlook 129Chapter 4 China 132Summary 132Introduction 133Geographic 133Political 133Economic 134Market dynamics 136Vital statistics 136Population statistics 136Epidemiology and prevalence of major disease 136Pharmaceutical market 138CRO market 140Overseas CROs 142Joint venture companies 143Local CROs 144Clinical trial market 146Market drivers 147Rapid patient recruitment from large pool of treatment naïve patients 147Well-trained and motivated clinical trial investigators 147Major cost savings 147Increasing importance of the pharmaceutical market in China 148US government opens FDA offices in China 149Financial support and incentives from the Chinese government 149Creation of the Chinese Clinical Trial Register (CHiCTR) 150Key barriers 152Cultural and linguistic 152Emerging Clinical Trial Locations: Market dynamics and the changing healthcare and regulatory environment Page 5/13
  6. 6. Find Industry reports, Company profilesReportLinker and Market StatisticsDelays to application and gaining approval 152Due diligence required to ensure intellectual property protection 152Issues over importation and importation licenses 153Monitor compliance of SFDA GCP with ICH GCP 153Healthcare 154Healthcare system 154Overview 154Healthcare reforms 156Healthcare institutions 157Hospital resources 158Regulation 160Regulatory authorities 160State Food and Drug Administration (SFDA) 160Department of drug registration 161Clinical trial regulation 161Application and approval of the new drug clinical trial study 162Registration approval for the manufacture of the new drug for market 163Legislation 165Patent Law and WTO TRIPS 165Drug Administration Law of the Peoples Republic of China 168Outlook 172Chapter 5 Latin America 174Summary 174Introduction 175Geographic 175Brazil 175Argentina 175Mexico 176Political 176Brazil 176Argentina 176Mexico 177Economic 177Brazil 177Argentina 177Mexico 177Market dynamics 178Vital statistics - Brazil 178Population statistics 178Epidemiology and prevalence of major disease 178Vital statistics - Argentina 179Population statistics 179Epidemiology and prevalence of major diseases 179Vital statistics - Mexico 180Population statistics 180Epidemiology and prevalence of major disease 180Pharmaceutical market 182CRO market 185Clinical trial market 186Market drivers 188Emerging Clinical Trial Locations: Market dynamics and the changing healthcare and regulatory environment Page 6/13
  7. 7. Find Industry reports, Company profilesReportLinker and Market StatisticsSignificant cost savings 188High concentration of population in urban centers 188High ethnic diversity 189High patient enrolment, compliance and retention rates 189A major growing Latin American pharmaceutical market 190Reverse seasons advantages 190Commonality of Spanish language 190Accessibility to medical professionals and clinical trial investigators 190National clinical trials register Argentina 191Key barriers 191Concerns over intellectual property protection 191Inconsistent regulatory environment 192Cultural challenges and issues 193Healthcare 194Healthcare system- Brazil 194Hospital resources - Brazil 194Healthcare system - Argentina 195Hospital resources - Argentina 195Healthcare system - Mexico 196Hospital resources - Mexico 197Regulation and guidelines 198Regulatory authorities 198The Pan American Network for Drug Regulatory Harmonization(PANDRH) 198ANVISA - Brazil 198Brazilian Research Ethics Commission (CONEP) 199ANMAT - Argentina 201SSA - Mexico 202COFEPRIS - Mexico 202Clinical trial regulation 203Brazil 204Argentina 206Mexico 208Guidelines 209Good Clinical Practices: Document of the Americas 209The Buenos Aires Declaration on Ethics and Clinical Trials 212Import licenses for drugs in clinical trials - Mexico 215Outlook 216Chapter 6 Central and Eastern Europe 218Summary 218Introduction 219Geographic 219Czech Republic 220Poland 220Russian Federation 220Political 220Czech Republic 220Poland 221Russian Federation 221Economic 221Emerging Clinical Trial Locations: Market dynamics and the changing healthcare and regulatory environment Page 7/13
  8. 8. Find Industry reports, Company profilesReportLinker and Market StatisticsCzech Republic 221Poland 221Russian Federation 222Market dynamics 223Vital statistics 223Population statistics 223Epidemiology and prevalence of major diseases 225Pharmaceutical market 228CRO market 230Czech Republic 230Poland 230Russian Federation 231Clinical trial market 233Czech Republic 235Poland 235Russian Federation 236Market drivers 238Large eligible treatment naïve population who exhibit high retention rates 238Large pool of dedicated, well trained and motivated investigators 239Cost savings 239Centralized healthcare systems and well-developed referral systems 240Entry of Russian Federation into the World Trade Organization (WTO) 240Positive assessments by the US FDA (Poland) 241Key barriers 241Poor hospital infrastructure with inadequate medical equipment 241Cultural differences and issues 242Potential delays importing the study drug (Russia) 242Concerns and issues obtained from regulatory inspections by the FDA(Russia) 243Lack of clinical trial experience amongst hospital staff and hospital services 244Healthcare 245Healthcare system Czech Republic 245Hospital resources Czech Republic 246Healthcare system Poland 246Ministry of Health 247National health fund 247Territorial self-government administrations 247Hospital resources Poland 247Healthcare system Russian Federation 248Hospital resources Russian Federation 249Regulation and legislation 250Regulatory authorities 250SUKL Czech Republic 250NIL Poland 251RZN Russian Federation 252Clinical trial regulation 253Czech Republic 254Poland 258Russian Federation 258Legislation 261Emerging Clinical Trial Locations: Market dynamics and the changing healthcare and regulatory environment Page 8/13
  9. 9. Find Industry reports, Company profilesReportLinker and Market StatisticsPoland removes tax block for clinical trials 261Decree no. 226/2008 on good clinical practices - Czech Republic 261Russia 261Outlook 262Appendix 264Introduction to clinical trials 264Clinical trial phases 264Phase I 264Phase II 264Phase III 264Phase IV 265What is a clinical trial 265Clinical trials of pharmaceutical agents 265Types of clinical trial 266Pilot studies 266Proof of concept (PoC) trials 266Randomized clinical studies 267Controlled clinical trials 267Parallel studies 267Parallel group trials 267Cohort studies 268Case control studies 268Role of the chief investigator 268Clinical trial protocol and procedure 269Determination of the clinical trial size 269Role of the coordinating centre and trials unit 270Role of the trial coordinator 270The trial principle investigator 270Forms and data management 270Trial data analysis and evaluation 271Ethical issues and conduct of clinical trial research 271Interpretation and publication of clinical trial results 272Principle regulatory agencies 272The European Agency for the Evaluation of Medicinal Products (EMEA) 272The United States Food and Drug Administration (US FDA) 273Japanese Ministry of Health, Labor and Welfare (MHLW) 273Methodology statement 274Primary Data and Information Gathering 274Secondary data and information gathering 275Definitions of Product-Life Cycle stages 277Glossary of abbreviations and acronyms 277Index 284List of FiguresFigure 1.1: Key issues facing Pharma and Biotech companies 26Figure 1.2: Cost of bringing a drug to market ($m), 1975-2008 31Figure 1.3: Pharmaceutical R&D expenditure ($bn), 2004-2009e 32Figure 1.4: Biotechnology R&D expenditure ($bn), 2004-2009e 33Figure 1.5: Cost of clinical trials in the US ($bn), 2005-2011e 33Figure 2.6: Comparison of locations across selected countries 48Figure 2.7: Korean Food and Drug Administration (KFDA) Approval Process 53Emerging Clinical Trial Locations: Market dynamics and the changing healthcare and regulatory environment Page 9/13
  10. 10. Find Industry reports, Company profilesReportLinker and Market StatisticsFigure 2.8: CRO Segment Leaders 55Figure 2.9: Enhanced clinical site effectiveness (patients per site) in the emerging countries 58Figure 2.10: Fewer ineffective sites in the emerging countries 58Figure 2.11: Critical components for capacity building/conducting clinical trials 64Figure 2.12: Assessing clinical trial location feasibility 65Figure 2.13: CRO selection criteria 79Figure 3.14: GDP in India (%) by sector 86Figure 3.15: Projected growth of healthcare industry in India ($bn), 2008-2022 86Figure 3.16: Population projection (millions) in India, 2000-2020 87Figure 3.17: Pharma industry in India ($bn), 2007-2010 90Figure 3.18: Market share (%) between MNCs and local pharmaceutical companies in India, 2003- 2007 91Figure 3.19: Outsourced clinical trial market in India (US$), 2002-2010 96Figure 3.20: Clinical trials in India (by phase), 2009 97Figure 3.21: Types of disease and types of hospitals in India 100Figure 3.22: Cost of clinical trials (%) in India vs US 103Figure 3.23: Structure of healthcare system in India 109Figure 3.24: Current organogram of the Ministry of Health and Family Welfare 113Figure 3.25: Proposed organogram of the Ministry of Health and Family Welfare 114Figure 3.26: Approval categories of global clinical trials in India 119Figure 4.27: Administrative divisions of the Peoples Republic of China 135Figure 4.28: Pharma market in China ($), 2007-2008 139Figure 4.29: CRO market in China (US$), 2007-2012 141Figure 4.30: Cost of clinical trials (%) in China vs western countries 148Figure 4.31: The Chinese Healthcare System 155Figure 4.32: NRCMCS medical cover cost and benefits in China 157Figure 4.33: Current drug approval and evaluation process in China 163Figure 4.34: Application and approval procedure for clinical trials China 165Figure 4.35: Location of accredited sites for clinical trials in China 171Figure 5.36: Population projection (000s) Brazil, 2000-2050 178Figure 5.37: Population projection (thousands) Argentina, 2000-2050 179Figure 5.38: Population projection (thousands) Mexico, 2000-2050 181Figure 5.39: Forecast growth ($bn) Latin America pharmaceutical market, 2008-2013 182Figure 5.40: Latin America pharmaceutical market 2008 183Figure 5.41: No. of clinical trials in Latin America, 2000-2008 186Figure 5.42: Clinical trials by phase in Latin America (number of trials), 2008 187Figure 5.43: Registered Research Ethics Committees (REC) by Region Brazil 2008 201Figure 5.44: Regulation of clinical trials in Latin America 2007 203Figure 5.45: Regulatory flowchart - Brazil 205Figure 5.46: Regulatory flowchart - Argentina 207Figure 5.47: Regulatory flowchart - Mexico 209Figure 6.48: Pharmaceutical market by selected Central and Eastern European countries, 2007 228Figure 6.49: Clinical trials Europe 234Figure 6.50: Clinical trials by phase (no trials) in the Czech Republic, 2008 235Figure 6.51: Clinical trials market ($m) in Poland, 2007-2010 236Figure 6.52: Clinical trials by therapy area (%) in Russia, 2008 237Figure 6.53: Clinical trials by phase (%) in Russia, 2008 238Figure 6.54: FDA inspection deficiencies in Russian sites 244List of TablesTable 2.1: Demographics of selected emerging markets, 2007 50Table 2.2: Ethical principles & their application for research 72Emerging Clinical Trial Locations: Market dynamics and the changing healthcare and regulatory environment Page 10/13
  11. 11. Find Industry reports, Company profilesReportLinker and Market StatisticsTable 3.3: Statistical healthcare data India 88Table 3.4: Ten leading causes of death (%) in India, 2002 88Table 3.5: Diseases of the developed world in India 89Table 3.6: Top 10 pharmaceutical companies ($m) in India, 2008 92Table 3.7: Major biotechnology products in India and their companies 93Table 3.8: Major CROs operating in India 95Table 3.9: Major specialty hospital groups operating in Northern India 98Table 3.10: Regulatory authorities based in Northern India 99Table 3.11: Snapshot of hospitals in India 111Table 4.12: China Population Projections (m people), 1950-2050 137Table 4.13: Ten leading causes of death in China, 2002 137Table 4.14: Prevalence of major cancers in China, 2007 138Table 4.15: Top 10 pharmaceutical companies ($m) in China, 2008 140Table 4.16: Major multinational CROs operating in China 142Table 4.17: Local Chinese owned CROs 145Table 4.18: Number of healthcare institutions according to ownership China 158Table 4.19: Total number of hospitals by ranking China 159Table 4.20: Chinese government agencies responsible for drug regulation 160Table 5.21: Ten leading causes of death, Argentina, 2003 180Table 5.22: Ten leading causes of death, Mexico, 2004 (compared to rate in 2000) 181Table 5.23: Top 10 pharma companies ($m) in Brazil, Argentina, and Mexico, 2008 184Table 5.24: Major CROs operating in Latin America, 2009 185Table 5.25: Ten leading causes of death in Brazil, 2003 195Table 5.26: Snapshot of hospitals in Argentina, 2007 196Table 6.27: Central and Eastern Europe population projection (m people), 2009 223Table 6.28: Population statistics - Russia 224Table 6.29: Principle city population statistics Russia, 2008 225Table 6.30: Estimated total deaths (thousands) by cause and by selected country 227Table 6.31: Top 10 pharmaceutical companies ($m) in Russia, Poland and the Czech Republic, 2008 229Table 6.32: Major CROs operating in Eastern Europe (including Poland and Czech Republic), 2009 231Table 6.33: Top 10 Russian regions by no. of new investigative sites, 2006-2008 237Table 6.34: Snapshot of hospitals in the Czech Republic 246Table 6.35: Snapshot of hospitals in Poland 248Table 6.36: Contact details regulatory authorities in selected Central and Eastern European countries 251Table 6.37: Fees for clinical trial application () in the Czech Republic, April 2009 255Table 6.38: Guidelines and Forms for Clinical Trials Czech Republic 256Table 6.39: Checklist of documents for initial application in Czech Republic 257Emerging Clinical Trial Locations: Market dynamics and the changing healthcare and regulatory environment Page 11/13
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