Clinical trials in Poland 2008

DESCRIPTION

Clinical trials in Poland 2008 is the second edition of our research of the sector and thus it offers you a unique opportunity to keep track of market trends and developments over the last several years. It provides a comprehensive study of the sector, with data on its value and development prospects.

Based on a recent PMR research and exclusive interviews with experts in the field, the report reveals the attitudes of managers of pharmaceutical companies and CROs towards the market, and situates Poland’s clinical trials in the context of other Central and Eastern European countries.

A database of over 60 CROs active on the Polish market is added to the report as a supplement, containing the following information:

• company name
• address
  
• website
  
• e-mail
  
• fax number
  
• telephone number.

• key trends and circumstances affecting the sector in 2007 and 2008
• present-day market size with forecasts for 2008-2010.

• the current and anticipated situation on the market
• market growth opportunities and obstacles
• the average registration time for clinical trials in Poland
• main characteristics and market standing of major companies conducting clinical trials in Poland in 2007 and 2008 (data presented in an aggregated form).

• number of trials
• location
• therapeutic areas.

• modifications to be introduced by the anticipated Clinical Trials Act
• legislation governing the involvement of minors in clinical trials
• responsibility in clinical trials
• taxation
• inspections
• personal data protection
• researchers' remuneration.

• Clinical Research Organisations (CROs) and pharmaceutical companies interested in launching operations in Poland or cooperating with their Polish counterparts
• pharmaceutical companies and CROs keen to keep track of Poland’s clinical trials market
• other companies active on the Polish clinical trials market, such as Site Management Organisations (SMOs) or companies interested in providing medical equipment and clinical trial materials
• decision makers who need to gain a thorough understanding of the key trends on the market.

• Size of clinical trials market in Poland
• 2005-2010 19
• Major events and trends on the clinical research market 19
  • Major market events and trends 2007-2008 19
  • Forecast market events and trends 2008-2010 20
• Size of Polish clinical trials market 2005-2010 21
• Results of survey of 110 companies conducting
• clinical research in Poland 23
• Introduction 23
• Evaluation of situation on Polish clinical research market 24
  • Assessment of current situation 24
  • Predictions for the coming 12 months 26
• Development forecasts for Polish clinical trials market 27
  • Annualised growth in patient number 27
  • Annualised growth in market size 28
  • Trends anticipated for the Polish clinical trials market 29
• Opportunities for and obstacles to expansion of clinical research market in Poland 33
• Clinical trial registration in Poland 36
  • Assessment of CEBK 36
  • Average trial registration time 37
• Profiles and market situation of firms conducting clinical research in Poland 38
  • Financial standing 38
  • Firms with foreign investors 41
  • Number of clinical trials conducted 41
  • Number of patients participating in trials 42
  • Main areas of interest of companies conducting clinical trials in Poland 43
    • Categories of drugs tested in 2007 43
    • Therapeutic groups with best research prospects 43
• Length of experience of clinical research firms in Poland 44
• Employment at CRO and pharma firms 45
• Foreign operations 45
• Comparative analysis of clinical research environment in Poland and selected other CEE countries 47
• Comparison of basic parameters in selected CEE countries 47
• Comparative analysis of clinical trials conducted by international concerns in Poland and in the CEE region 52
  • Pfizer 53
  • GlaxoSmithKline 56
  • Roche 58
  • Sanofi-Aventis 60
  • Bristol-Myers Squibb 63
  • AstraZeneca 65
  • Novartis 68
  • Eli Lilly 70
  • Merck&Co. 73
  • Johnson&Johnson 75
  • Amgen 78
  • Wyeth 80
• Trial registration 82
• Costs of conducting a study 83
• Patient recruitment 84
• Researcher qualifications 86
• Trial quality 86
• Clinical trials inspections in Central and
• Eastern Europe 87
• Number of clinical trials in CEE 91
  • Russia 93
  • Poland 93
  • Czech Republic 94
  • Hungary 94
  • Slovakia 95
  • Romania 95
  • Ukraine 96
  • Bulgaria 96
• Profiles of select CROs active in Poland 97
• Quintiles Poland 97
• KCR 98
• Scope International 99
• MTZ Clinical Research 99
• Parexel Polska 100
• Monipol 100
• Paragon Biomedical 101
• MDS Pharma Services Poland 101
• Averion International 102
• PSI Pharma Support 102
• Covance Polska 103
• PPD 104
• Legislative environment 105
• Key legislation and institutions regulating clinical research in Poland 105
• Obtainment of clinical trials licence in Poland 106
  • Applying to commence clinical trials 106
  • Fees for submission of clinical trial registration application 107
  • Duration of processing of applications 107
  • Principle of “tacit consent” 109
  • Refusal to issue a licence 109
• Procedures relating to the work of
• ethics committees 110
• Adverse events during clinical trials 111
• Insuring clinical trials 112
• Claims in clinical trials 112
• Contracts in clinical trials 114
  • Changes regarding contract documents to be submitted to the CEBK 114
  • Preliminary contracts 114
  • Tripartite contracts 115
• Liability in clinical trials 115
  • Civil liability 116
    • Product liability 116
    • Liability in tort 116
    • Contractual liability 116
  • Criminal liability 117
  • Disciplinary responsibility 117
• VAT on clinical trials 117
• Personal data protection in clinical trials 118
  • Medical documentation 119
• Remuneration of researchers 119
• EudraCT database 120
• Outsourcing of clinical trials 121
• Clinical trials with minors 121
  • National standards 121
  • European standards 122
• Planned amendments to clinical trial regulations 123
  • Clinical Trials Act 123
  • Ordinance on Template of Application to Commence a Clinical Trial 124
    • Application to the Health Ministry 124
    • Application to Bioethics Committee 125
  • Changes planned in the “minor amendment” to the Pharmaceutical Law 125
    • Non-commercial trials 126
    • Inspections of clinical trials 127
• Investigational medicinal product 128

• By ordering a "single user licence" the client is purchasing the right to use the publication on one computer workstation only. Any copying, distribution or dissemination of the electronic publication via a computer network (in part or in whole) is strictly prohibited. Delivered by e-mail in PDF format.
• By ordering a "5-user licence" the client is purchasing a licence authorising the copying, distribution and dissemination of the electronic publication via a computer network (in part or in whole) among a maximum of 5 people within the company indicated on the order form (including all company subsidiaries in a single country location). Delivered by e-mail in PDF format.

• By ordering a "company licence" the client is purchasing a licence authorising the unrestricted copying, distribution and dissemination of the electronic publication (in part or in whole) via a computer network solely within the company indicated on the order form (including all company subsidiaries in a single country location). CD delivered by courier. CD version contains PDF version of the report plus an extra file with all the graphs and tables in a copiable format easy to use in your own analyses, presentations, etc.
• By ordering a "global licence" the client is purchasing a licence authorising the unrestricted copying, distribution and dissemination of the electronic publication (in part or in whole) via a computer network solely within the organisation indicated on the order form, regardless of country location. CD delivered by courier. CD version contains PDF version of the report plus an extra file with all the graphs and tables in a copiable format easy to use in your own analyses, presentations, etc.