Keywords : clinical trial, clinical research, contract research organisation
Clinical trials in Poland 2012 Development forecasts for 2012-2014 Clinical trials in Poland 2012, Development forecasts for 2012-2014 delivers a complete description of current conditions in the marketplace for clinical trials of drugs and therapies. This report presents the most influential events and trends and analyses their current and potential effects on the quantity and types of trials conducted by both Polish and multinational ...
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- Publication date: June 2012
- Report size: 187 pages
- Report price: $ 2 800
Clinical trials in Poland 2012
Development forecasts for 2012-2014
Clinical trials in Poland 2012, Development forecasts for 2012-2014 delivers a complete description of current conditions in the marketplace for clinical trials of drugs and therapies. This report presents the most influential events and trends and analyses their current and potential effects on the quantity and types of trials conducted by both Polish and multinational companies.
It supplies information on the value of this segment of the larger pharmaceutical market and provides in depth predictions of future market conditions, opportunities and value based on upcoming trials and changes in the economic and regulatory environments, supply of medical facilities and personnel willing and able to participate, and demographics and epidemiological trends. The report compares statistics from recent years to current activity, and uses detailed profiles of actual clinical trials conducted by both Polish and international companies to illustrate how major players navigate procedural issues in this market.
This document describes Major Contract Research Organisations (CROs) in terms of financial data and activity, with the added benefit of an Excel database and analysis of the findings of a special survey of 100 companies engaged in the marketplace. An entire chapter is devoted to the projects and strategies of Polish companies for the coming years. The report also conducts analysis of the conditions in Poland as compared to those in clinical trials markets in other Central European countries.
Legal and regulatory conditions play a central role in recent market development, and this study explores them at length. It reveals the effects of procedural changes at the Central Register of Clinical Trials on registration time periods and other roadblocks to smooth and expedient clinical drug trials, and projects the effects of new laws currently in the drafting stage and the impending expiration of regulations that have governed business procedure in recent years.
Drug Discovery And Development Industry in Poland
Clinical trials in Poland 2012
Development forecasts for 2012-2014
1. Report methodology 11
2. Executive summary 17
3. Size of the clinical trials market in Poland in 2007-2014 23
4. Major events and trends on the Polish clinical trials market in 2010-2012 23
5. Expected trends and events in 2012-2014 32
6. Value of the Polish clinical trials market in 2005-2014 34
7. Number of clinical trials conducted in Poland in 1994-2011 35
8. Phases 37
9. Therapeutic categories 38
10. Results of survey of 100 companies conducting clinical research in Poland 39
11. Introduction 39
12. Evaluation of current situation on Polish clinical research market 40
13. Development forecasts for Polish clinical trials market 41
14. Predictions for the situation on the market in 2012 41
15. Trends anticipated for the Polish clinical trials market 43
16. Assessment of the established Academic Clinical Trial Unit 47
17. Opportunities for and obstacles to expansion of clinical trials market in Poland 49
18. Anticipated legal changes with a positive effect on the market 52
19. Clinical trial registration in Poland 53
20. Assessment of CEBK 53
21. Average trial registration time 55
22. Ideas for facilitating clinical trial registration in Poland 56
23. Profiles and market situation of firms conducting clinical research in Poland 57
24. Number of companies conducting clinical trials on the Polish market 57
25. Number of clinical trials conducted 58
26. Number of patients participating in trials 59
27. Main areas of interest of companies conducting clinical trials in Poland 59
28. Phases of clinical trials 60
29. Financial standing 61
30. Firms with foreign investors 62
31. Revenue of companies conducting clinical trials in Poland 64
32. Period of presence of clinical research firms in Poland 65
33. Employment at CROs and pharma firms 65
34. Foreign operations 67
35. Clinical trials conducted by international concerns in Poland 69
36. Number of clinical trials conducted 69
37. Clinical trials conducted by Polish companies 99
38. Market value 99
39. Research and development activities of Polish companies 100
40. Innovation rankings 100
41. Innovation projects – Innovative Economy Operational Programme 102
42. Profiles of selected CROs operating on the Polish market 115
43. International CROs 115
44. Comparative analysis of clinical research environment in Poland and selected CE countries 133
45. Number of clinical sites 133
46. Patient recruitment 135
47. Quality 136
48. Cost of clinical trials 137
49. General comparison 137
50. Inspections of clinical trials 138
51. Assessment of Poland’s potential as a site for clinical trials 141
52. Demographic trends 141
53. Epidemiological trends and the most frequent causes of death 143
54. Medical personnel 145
55. Healthcare establishments 147
56. Number of hospitals 147
57. Number of hospital wards 148
58. Number of beds 149
59. Number of patients 151
60. Legislative environment 153
61. Key legislation and institutions regulating clinical research in Poland 153
62. Obtainment of clinical trials licence in Poland 155
63. Application to Ministry of Health 155
64. Charges for filing applications for clinical trial registration 157
65. Deadline for processing applications 157
66. Principle of “tacit consent” 158
67. Refusal to issue a license 158
68. Issuing opinions on clinical trials 159
69. Allocation of costs in clinical trials 161
70. VAT on clinical trials 162
71. Remuneration of investigators 162
72. Insuring clinical trials 163
73. Claims in clinical trials 164
74. Liability in clinical trials 165
75. Civil liability 165
76. Criminal liability 167
77. Disciplinary responsibility 167
78. Personal data protection in clinical trials 168
79. Medical documentation 168
80. Non-commercial clinical trials 169
81. Clinical trials with minors 170
82. National standards 170
83. European standards 171
84. Planned legislative changes to the Clinical Trials Law 172
85. Clinical Trials Law 172
86. Regulation on inspection of clinical trials 174
87. Ordinance on Good Clinical Practice 174
88. Regulation on templates for the documents submitted for a clinical trial and fees 174
89. Revisions to Directive 2001/20/EC 175
90. List of graphs 177
91. List of tables 183
92. About PMR 185
93. Contact PMR 186
Clinical Trial in Poland
- $ 250
- Industry data
- January 2013
Yearly, From 2006 To 2010
By Business Monitor International
Source: ClinicalTrials.gov, BMI. N.B. Sourced by date of initial registration.
- Industries : Drug Discovery and Development
- Countries : Poland
- $ 250
- Industry data
- January 2013
Yearly, From 2006 To 2010
By Business Monitor International
Source: ClinicalTrials.gov, BMI. N.B. Sourced by date of initial registration.
- Industries : Drug Discovery and Development
- Countries : Poland
- $ 250
- Industry data
- January 2013
Yearly, From 2006 To 2010
By Business Monitor International
Source: ClinicalTrials.gov, BMI. N.B. Sourced by date of initial registration.
- Industries : Drug Discovery and Development
- Countries : Poland
- $ 250
- Industry data
- January 2013
Yearly, From 2006 To 2010
By Business Monitor International
Source: ClinicalTrials.gov, BMI. N.B. Sourced by date of initial registration.
- Industries : Drug Discovery and Development
- Countries : Poland
- $ 250
- Industry data
- January 2013
Yearly, From 2006 To 2010
By Business Monitor International
Source: ClinicalTrials.gov, BMI. N.B. Sourced by date of initial registration.
- Industries : Drug Discovery and Development
- Countries : Poland
- Publication date: June 2012
- Report size: 187 pages
- Report price: $ 2 800
