2008-08-26 23:36:02 -
www.researchandmarkets.com - Research and Markets (www.researchandmarkets.com/research/55b871/clinical_trials_in) has announced the addition of the "Clinical Trials in Poland 2008. Development Forecasts for 2008-2010" report to their offering.
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 our recent 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
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
- 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
Executive Summary:
Key Sections
Section one provides crucial information concerning the present value of the clinical trials market in Poland in the years 2005-2007, with forecasts for 2008-2010. It includes major trends and circumstances that have affected the development of the sector in the last couple of years.
Section two is based on the results of our research carried out among 100 companies active on the market with a sample response rate of 63%. It outlines the present-day situation on the market and determines opportunities for and obstacles to its further development. It provides information on the average registration time for clinical trials in Poland and presents assessment of financial standing and future prospects of major companies conducting such trials in Poland in 2007 and 2008.
Section three presents a comparative analysis of conditions under which clinical trials are conducted in Poland and in other CEE countries.
Section four discusses legal aspects of the sector, providing information on the upcoming legislative modifications regarding clinical trials. It also includes such details as taxation and inspections of clinical trials, as well as personal data protection and the remuneration of researchers.
Report Overview
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
Then we present the results of our recent research, which was carried out on the management staff of over 60 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 CEE countries.
Operations of major pharmaceutical corporations active in CEE 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, among others, 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
Key Topics Covered:
Report methodology
Executive summary
Size of clinical trials market in Poland 2005-2010
Major events and trends on the clinical research market
Major market events and trends 2007-2008
Forecast market events and trends 2008-2010
Size of Polish clinical trials market 2005-2010
Results of survey of 110 companies conducting clinical research in Poland
Introduction
Evaluation of situation on Polish clinical research market
Assessment of current situation
Predictions for the coming 12 months
Development forecasts for Polish clinical trials market
Annualised growth in patient number
Annualised growth in market size
Trends anticipated for the Polish clinical trials market
Opportunities for and obstacles to expansion of clinical research market in Poland
Clinical trial registration in Poland
Assessment of CEBK
Average trial registration time
Profiles and market situation of firms conducting clinical research in Poland
Financial standing
Firms with foreign investors
Number of clinical trials conducted
Number of patients participating in trials
Main areas of interest of companies conducting clinical trials in Poland
Categories of drugs tested in 2007
Therapeutic groups with best research prospects
Length of experience of clinical research firms in Poland
Employment at CRO and pharma firms
Foreign operations
Comparative analysis of clinical research environment in Poland and selected other CEE countries
Comparison of basic parameters in selected CEE countries
Comparative analysis of clinical trials conducted by international concerns in Poland and in the CEE region
Pfizer
GlaxoSmithKline
Roche
Sanofi-Aventis
Bristol-Myers Squibb
AstraZeneca
Novartis
Eli Lilly
Merck&Co.
Johnson&Johnson
Amgen
Wyeth
Trial registration
Costs of conducting a study
Patient recruitment
Researcher qualifications
Trial quality
Clinical trials inspections in Central and Eastern Europe
Number of clinical trials in CEE
Russia
Poland
Czech Republic
Hungary
Slovakia
Romania
Ukraine
Bulgaria
Profiles of select CROs active in Poland
Quintiles Poland
KCR
Scope International
MTZ Clinical Research
Parexel Polska
Monipol
Paragon Biomedical
MDS Pharma Services Poland
Averion International
PSI Pharma Support
Covance Polska
PPD
Legislative environment
Key legislation and institutions regulating clinical research in Poland
Obtainment of clinical trials licence in Poland
Applying to commence clinical trials
Fees for submission of clinical trial registration application
Duration of processing of applications
Principle of "tacit consent"
Refusal to issue a licence
Procedures relating to the work of ethics committees
Adverse events during clinical trials
Insuring clinical trials
Claims in clinical trials
Contracts in clinical trials
Changes regarding contract documents to be submitted to the CEBK
Preliminary contracts
Tripartite contracts
Liability in clinical trials
Civil liability
Product liability
Liability in tort
Contractual liability
Criminal liability
Disciplinary responsibility
VAT on clinical trials
Personal data protection in clinical trials
Medical documentation
Remuneration of researchers
EudraCT database
Outsourcing of clinical trials
Clinical trials with minors
National standards
European standards
Planned amendments to clinical trial regulations
Clinical Trials Act
Ordinance on Template of Application to Commence a Clinical Trial
Application to the Health Ministry
Application to Bioethics Committee
Changes planned in the "minor amendment" to the Pharmaceutical Law
Non-commercial trials
Inspections of clinical trials
Investigational medicinal product
List of graphs
List of tables
Companies Mentioned:
- Pfizer
- GlaxoSmithKline
- Roche
- Sanofi-Aventis
- Bristol-Myers Squibb
- AstraZeneca
- Novartis
- Eli Lilly
- Merck&Co.
- Johnson&Johnson
- Amgen
- Wyeth
- Quintiles Poland
- KCR
- Scope International
- MTZ Clinical Research
- Parexel Polska
- Monipol
- Paragon Biomedical
- MDS Pharma Services Poland
- Averion International
- PSI Pharma Support
- Covance Polska
- PPD
For more information visit
www.researchandmarkets.com/research/55b871/clinical_trials_in.
Research and Markets
Senior Manager
Laura Wood,
press@researchandmarkets.com
Fax from USA: 646-607-1907
Fax from rest of the world: +353-1-481-1716
