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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 over 100 pharmaceutical companies and CROs towards the market, and situates Poland’s clinical trials in the context of other CEE countries.
A database of over 60 CROs active on the Polish market is also added to the report as a supplement.
Clinical trials in Poland 2008 begins with a presentation of key facts regarding the market’s size and condition. It provides data on:
- key trends and circumstances affecting the sector in 2007 and 2008
- present-day market size with forecasts for 2008-2010.
We then present the results of a recent PMR research, which was carried out on the management staff of over 100 CROs and pharmaceutical companies active on the Polish market. It has revealed the following information:
- 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).
The report also includes a comparative analysis of conditions governing the performance of clinical trials in Poland and in selected Central and Eastern European countries.
Operations of major pharmaceutical corporations active in Central and Eastern European countries are then presented, with special attention given to companies active in Poland. This includes the following details :
- number of trials
- location
- therapeutic areas.
We also provide profiles and basic information on the biggest Clinical Research Organisations (CROs) in Poland.
Finally, the report includes crucial information on legal conditions regulating the market. It provides the latest data on the following aspects:
- 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.
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
Target Readership
Clinical trials in Poland 2008 will be particularly useful to:
- 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.
List of graphs
- Value of clinical research market in Poland (PLN m), best-case scenario, 2005-2010
- Value of clinical research market in Poland (PLN m), worst-case scenario, 2005-2010
- Value of clinical research market in Poland (PLN m), best-case scenario, 2005-2010
- Value of clinical research market in Poland (PLN m), worst-case scenario, 2005-2010
- Assessment of current situation on clinical research market in Poland, May 2008
- Main reasons for positive assessments of clinical trials market in Poland, May 2008
- Will the situation in the clinical research sector in Poland deteriorate, improve or remain unchanged in the next year?, May 2008
- Will the number of patients participating in clinical trials increase, decrease or not change in 2008 relative to 2007?
- In your opinion, by how much will the number of patients participating in Poland in clinical trails increase in 2008 relative to 2007 (% of respondents)?
- Will the Polish clinical trials market grow, contract or not change in 2008 relative to 2007?
- In your opinion, by how much will the Polish clinical trials market expand in 2008 relative to 2007?
- There will be more academic clinical trials in Poland in the future, May 2008
- Poland will be losing its competitive edge as a place to conduct clincial trials in CEE, May 2008
- More Phase I trials will be organised in Poland, May 2008
- Key barriers to business development of firms active on the clinical trials market in Poland, 2006 and 2008
- Key factors which could stimulate development of clinical trials market in Poland, 2006 and 2008
- How would you assess CEBK’s work in clinical trial registration in Poland, May 2008
- Key reasons for negative assessments of the CEBK’s work in Poland, May 2008
- Average time it takes to register a clinical trial in Poland (no. of firms), May 2008
- Assessment of the current financial standing of your clinical research firm in Poland relative to a year earlier, May 2008
- Assessment of financial standing of clincial research firms in Poland, 2006 and 2008
- Respondents’ predictions on financial standing of their clinical research firms in Poland for the next 12 months, May 2008
- Respondents’ predictions on financial standing of their clincial research firms for the upcoming year, 2006 and 2008
- Polish and foreign firms on the clinical research market in Poland, 2008
- How many trials did your company conduct in Poland in 2007?, May 2008
- Number of patients involved in clinical trials for the average company in Poland, 2005-2008
- Therapeutic groups subject to research in Poland (% of firms engaging in a given type of trial), May 2008
- What therapeutic groups will be increasingly tested in clinical trials in Poland?, May 2008
- Number of years your company has been present on the Polish clinical trials market, May 2008
- Does your firm organise clinical trials outside of Poland?, May 2008
- Countries, in which firms present in Poland most often organise trials (no. of firms), May 2008
- Share of CEE countries in total number of trials in the region, May 2008
- Number of clinical trials conducted in Poland by international pharma concerns, May 2008
- Number of clinical trials conducted in CEE by Pfizer, May 2008
- Share of trials conducted in Poland and in CEE in all trials conducted by Pfizer, May 2008
- Share of trials conducted in Poland in trials conducted by Pfizer in CEE, May 2008
- Therapeutic areas of Pfizer trials conducted in CEE, May 2008
- Number of clinical trials conducted in CEE by GlaxoSmithKline, May 2008
- Share of trials conducted in Poland and in CEE in all trials conducted by GSK, May 2008
- Share of trials conducted in Poland in trials conducted by GSK in CEE, May 2008
- Therapeutic areas of GSK trials conducted in CEE, May 2008
- Number of clinical trials conducted in CEE by Roche, May 2008
- Share of trials conducted in Poland in trials conducted by Roche in CEE, May 2008
- Therapeutic areas of Roche trials conducted in CEE, May 2008
- Number of clinical trials conducted in CEE by Sanofi-Aventis, May 2008
- Share of trials conducted in Poland and in CEE in all trials conducted by Sanofi-Aventis, May 2008
- Share of trials conducted in Poland in trials conducted by Sanofi-Aventis in CEE, May 2008
- Therapeutic areas of Sanofi-Aventis trials conducted in CEE, May 2008
- Number of clinical trials conducted in CEE by Bristol-Myers Squibb, May 2008
- Share of trials conducted in Poland and in CEE in all trials conducted by Bristol-Myers Squibb, May 2008
- Share of trials conducted in Poland in trials conducted by Bristol-Myers Squibb in CEE, May 2008
- Therapeutic areas of Bristol-Myers Squibb trials conducted in CEE, May 2008
- Number of clinical trials conducted in CEE by AstraZeneca, May 2008
- Share of trials conducted in Poland and in CEE in all trials conducted by AstraZeneca, May 2008
- Share of trials conducted in Poland in trials conducted by AstraZeneca in CEE, May 2008
- Therapeutic areas of AstraZeneca trials conducted in CEE, May 2008
- Number of clinical trials conducted in CEE by Novartis, May 2008
- Share of trials conducted in Poland and in CEE in all trials conducted by Novartis, May 2008
- Share of trials conducted in Poland in trials conducted by Novartis in CEE, May 2008
- Therapeutic areas of Novartis trials conducted in CEE, May 2008
- Number of clinical trials conducted in CEE by Eli Lilly, May 2008
- Share of trials conducted in Poland and in CEE in all trials conducted by Eli Lilly, May 2008
- Share of trials conducted in Poland in trials conducted in CEE by Eli Lilly, May 2008
- Therapeutic areas of Eli Lilly trials conducted in CEE, May 2008
- Number of clinical trials conducted in CEE by Merck&Co., May 2008
- Share of trials conducted in Poland and in CEE in all trials conducted by Merck&Co., May 2008
- Share of trials conducted in Poland in trials conducted by Merck&Co. in CEE, May 2008
- Therapeutic areas of Merck&Co. trials conducted in CEE, May 2008
- Number of clinical trials conducted in CEE by Johnson&Johnson, May 2008
- Share of trials conducted in Poland and in CEE in all trials conducted by Johnson&Johnson, May 2008
- Share of trials conducted in Poland in trials conducted by Johnson&Johnson in CEE, May 2008
- Therapeutic areas of Johnson&Johnson trials conducted in CEE, May 2008
- Number of clinical trials conducted in CEE by Amgen, May 2008
- Share of trials conducted in Poland and in CEE in all trials conducted by Amgen, May 2008
- Share of trials conducted in Poland in trials conducted by Amgen in CEE, May 2008
- Therapeutic areas of Amgen trials conducted in CEE, May 2008
- Number of clinical trials conducted in CEE by Wyeth, May 2008
- Share of trials conducted in Poland and in CEE in all trials conducted by Wyeth, May 2008
- Share of trials conducted in Poland in trials conducted by Wyeth in CEE, May 2008
- Therapeutic areas of Wyeth trials conducted in CEE, May 2008
- Time (in months) between trial acceptance and first patient visit in selected countries, 2007
- Costs of conducting clinical trials in selected countries, 2007
- Success of patient recruitment in clinical trials in Poland and Russia relative to US, 2002-2005
- Success of patient recruitment in clinical trials in selected countries (number of patients per centre), 2007
- Success of patient recruitment for clinical trials in selected European countries (number of patient per country)
- Number of violations reported per 100 pages of the Clinical Research Form in selected CEE and other countries, 2007
- Time (in days) needed to clarify concerns reported in the Clinical Research Form in selected CEE countries
- FDA inspections carried out in CEE by year, 1994-2008
- Findings of FDA inspections carried out in CEE, 1994-2008
- Findings of FDA inspections conducted in selected CEE countries, 1994-2008
- FDA inspection findings in Western Europe, CEE, and US, 1994-2008
- Violations in CEE clinical trials reported after FDA inspections, 1994-2008
- Most common violations reported in FDA inspections in Poland, Russia and Hungary, 1994-2008
- Size of CEE clinical trials market (number of trials), 2000-2006
- Number of clinical trials per one million inhabitants in selected CEE countries, 2000-2006
- Average annual growth in number of clinical trials conducted CEE, 2000-2006
- Number and y-o-y change of clinical trials conducted in Russia, 1994-2007
- Number and y-o-y change of clinical trials conducted in Poland, 1994-2007
- Number and y-o-y change of clinical trials conducted in the Czech Republic, 1994-2006
- Number and y-o-y change of clinical trials conducted in Hungary, 1994-2007
- Number and y-o-y change of clinical trials conducted in Slovakia, 1994-2006
- Number and y-o-y change of clinical trials conducted in Romania, 1997-2005
- Number and y-o-y change of clinical trials conducted in Ukraine, 1994-2005
- Number and y-o-y change of clinical trials conducted in Bulgaria, 1996-2006
- Quintiles’ sales revenues (PLN m) in Poland, 2006-2007
- KCR’s sales revenues and net profits (PLN m), 2006-2007
- Parexel’s global sales revenues on clinical trials ($ m), 2005-2007
- MDS Pharma Services’ global sales revenues ($ m), 2005-2007
- Covance’s global sales revenues and net profits ($ m), 2005-2007
- PPD’s global revenues and net profit ($m), 2005-2007
- Statutory deadline for processing applications to commence clinical trials in Poland, 2008
- Procedure for registering a clinical trial in Poland, 2008
- Types of liability applicable to clinical research and relevant legislation in Poland, 2008
List of tables
- Comparison of trial conditions in Poland to conditions in Ukraine, Hungary and the Czech Republic, May 2008
- Comparison of basic parameters of conducting clinical trials in Poland, Russia, Czech Republic, Romania, Turkey, Ukraine, Bulgaria, and Hungary, 2008
- Minimum guaranteed sum of civil liability cover for researchers and sponsors of clinical trials in Poland, 2008
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