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Clinical Trials


Clinical trials in Poland 2008

Development forecasts for 2008-2010

Publication Date   June 2008
Publisher   PMR Publications
Product Type   Report
Pages   140
ISBN Number   not applicable
Product Code   PMR013
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Price £1,340.00

approximately: $2,056 | €1,576

Summary


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 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 a PMR 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 a recent PMR 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.

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.

Content


  • 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
  • About PMR
  • Contact PMR