Clinical trials in Poland 2008

Transcription

1 Clinical trials in Poland 2008 Development forecasts for Publication date: June 2008 Language: English, Polish

2 A word from the authors Poland is one of the largest markets for clinical trials in Central and Eastern Europe. Despite certain administrative and legal obstacles, Poland's share in the entire clinical trails market has been fairly high and stable for several years. Well aware of insufficient availability of detailed information on the market, we decided to deliver our second report providing companies operating in the sector with complete picture of the clinical trails industry. Our analysis is a unique study based on a research carried out among a representative sample of pharmaceutical companies and CROs operating in Poland. Monika Stefanczyk, Senior Pharmaceutical Analyst Agnieszka Stawarska, Pharmaceutical Analyst 2

3 PMR MarketInsight Methodology This report was prepared using PMR s MarketInsight Methodology. PMR MarketInsight is a methodology developed by PMR which assists in the complex preparation of industry reports. It defines the ways in which data should be collected for such reports and outlines the methods to be used in analysing the information collected in order to obtain a true picture of the market in question. It also contains special procedures to follow in the case of incomplete market. PMR MarketInsight precisely defines report content and structure. Industry reports prepared using PMR MarketInsight are based on information from a variety of available statistical, industry (specialist press, the internet), general and official sources as well as information from PMR s own database and primary research independently carried out by PMR. The sources we use are individually tailored to each project. PMR MarketInsight is the result of over 10 years of experience in conducting industry analysis on Central and Eastern European markets. MarketInsight PMR M e t h o d o l o g y 3

4 Legislative work on the Clinical Trials Law is underway. Report 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: ncompany name naddress nwebsite n nfax number ntelephone number. see how to order 4

5 Key sections Section one provides crucial information concerning the present value of the clinical trials market in Poland in the years , with forecasts for It includes major trends and circumstances that have affected the development of the sector in the last couple of years. International CROs interest in the CEE market is increasing. 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 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. see how to order 5

6 Patient recruitment in CEE is smooth and speedy. 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: nkey trends and circumstances affecting the sector in 2007 and 2008 npresent-day market size with forecasts for 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: nthe current and anticipated situation on the market nmarket growth opportunities and obstacles nthe average registration time for clinical trials in Poland nmain 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. see how to order 6

7 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 nlocation ntherapeutic areas. We also provide profiles and basic information on the biggest Clinical Research Organisations (CROs) in Poland. Inspection carried out by the FDA confirms high quality of clinical trials conducted 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: nmodifications to be introduced by the anticipated Clinical Trials Act nlegislation governing the involvement of minors in clinical trials nresponsibility in clinical trials ntaxation ninspections npersonal data protection nresearchers' remuneration. see how to order 7

8 449 trials were registered in Poland in Clinical trials in Poland 2008 will be particularly useful to: nclinical Research Organisations (CROs) and pharmaceutical companies interested in launching operations in Poland or cooperating with their Polish counterparts npharmaceutical companies and CROs keen to keep track of Poland s clinical trials market nother 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 ndecision makers who need to gain a thorough understanding of the key trends on the market. see how to order 8

9 Selected PMR Clients: ratiopharm 9

10 About PMR Ltd. Sp. z o.o. PMR Publications provides reliable market intelligence for business professionals interested in Central and Eastern European countries. Publications by PMR analyse the business climate in the region, in particular in the construction, retail, IT, telecommunications and pharmaceutical sectors. PMR Publications offers both free and paid subscription newsletters, internet news portals and indepth reports. To find out more about Poland and Central Eastern European countries please visit and as well as the regional and national sector portals dedicated to construction ( IT and telecom ( retail ( and pharma ( PMR Publications is a division of PMR Ltd. ( a publishing, consulting and market research company providing information, advice and services to international businesses interested in Central and Eastern Europe. With highly skilled staff, top ranked web sites and over ten years of experience, PMR is one of the largest companies of its type in the region. PMR Ltd. Sp. z o.o., ul. Supniewskiego 9, Krakow, Poland Questions about ordering? Contact our sales department: tel. /48/ fax /48/ sales@pmrcorporate.com

11 SUBSCRIPTION CARD TO ORDER RETURN THE FORM TO US VIA FAX ON: /48/ Please send me 1 2 Last YOUR LICENCE INVOICING DETAILS Clinical trials in Poland 2008 Development forecasts for Publication date: June 2008 Language: English, Polish English or Polish Both Single user licence* user licence** Corporate licence*** Global licence**** * 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 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 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. If your contact details are different to the invoicing details, please fax them to us together with the completed order form. Mr Mrs Ms Name Job title Country Tel./Fax Core business First Name Company Invoicing address EU VAT Number 3 4 PAYMENT FORM Subscription will be invoiced in PLN at current exchange rates. Polish clients need to add 22% VAT. Foreign clients will be invoiced in EURO. MONEY TRANSFER TO: PMR Ltd. Sp. z o.o. For Polish clients: Raiffeisen Bank Polska S.A. ul. Armii Krajowej 18, Krakow Account number: For foreign clients: Raiffeisen Bank S.A., ul. Armii Krajowej 18, Krakow Account number: PL SWIFT CODE: RCBWPLPW Correspondence address / Tel. to accounting CREDIT CARD: Diners Club Visa Eurocard / Mastercard American Express Account to be charged and currency (Credit card charges will be made in PLN at current exchange rates) Name of card owner Credit Card No Valid until Billing address of card I undertake to contact PMR Ltd. within seven days should I not receive any of the copies. In sending this form I authorise PMR Ltd. Sp. z o.o. to invoice me without my signature and to use the company details on the form for processing my subscription (Ustawa o ochronie danych osobowych Dz. U. nr 133/97, poz. 883) Signature: only signed forms can be processed Thank you! We will contact you soon to confirm your order. PMR Ltd. Sp. z o. o., tel. /48/ , fax /48/ , sales@pmrcorporate.com, ul. Supniewskiego 9, Kraków, Polska NIP number: , destination of region court: Sąd Rejonowy dla Krakowa-Śródmieścia w Krakowie XI Wydział Gospodarczy Krajowego Rejestru Sądowego, KRS number: , the amount of company s nominal capital: one hundred and thirty thousand