Clinical Trials in Poland 2008 - Development Forecasts for 2008-2010 Contains a Database of Over 60 CROs Active on the Polish Market.DUBLIN, Ireland -- Research and Markets (http://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 - 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 CIRCUMSTANCES, evidence. The particulars which accompany a fact. 2. The facts proved are either possible or impossible, ordinary and probable, or extraordinary and improbable, recent or ancient; they may have happened near us, or afar off; they are public or 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 cee n. The letter c. 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 REMUNERATION. Reward; recompense; salary. Dig. 17, 1, 7. 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 gov·ern v. gov·erned, gov·ern·ing, gov·erns v.tr. 1. To make and administer the public policy and affairs of; exercise sovereign authority in. 2. 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 Bristol-Myers Squibb (NYSE: BMY), colloquially referred to as BMS, is a pharmaceutical corporation, formed by a 1989 merger between pharmaceutical companies Bristol-Myers Company, founded in 1887 by William McLaren Bristol and John Ripley Myers in Clinton, NY (both were AstraZeneca Novartis Eli Lilly Eli Lilly can refer to:
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 The term "Central and Eastern Europe" came into wide spread use, replacing "Eastern bloc", to describe former Communist countries in Europe, after the collapse of the Iron Curtain in 1989/90. Number of clinical trials in CEE Russia Poland Czech Republic Czech Republic, Czech Česká Republika (2005 est. pop. 10,241,000), republic, 29,677 sq mi (78,864 sq km), central Europe. It is bordered by Slovakia on the east, Austria on the south, Germany on the west, and Poland on the north. Hungary Slovakia Romania Ukraine Bulgaria Profiles of select CROs active in Poland Quintiles Quintiles Transnational Corp. is a contract research organization which serves the pharmaceutical, biotechnology and healthcare industries. History Quintiles was founded in 1982 by Dennis Gillings and as of 2007 it has 18,000 employees. Poland KCR KCR Kowloon-Canton Railway (railway system connecting Hong Kong and Canton province of China) KCR Kansas City Royals KCR Key Component Review KCR Key Customer-Related Scope International MTZ MTZ Mass Transfer Zone (granular active carbon filter design - engineering) Mtz Martinez, CA MTZ Mali Airways (ICAO code) MTZ Moine Thrust Zone Clinical Research Parexel Polska Monipol Paragon Biomedical bi·o·med·i·cal adj. 1. Of or relating to biomedicine. 2. Of, relating to, or involving biological, medical, and physical sciences. MDS MDS, n See temporomandibular pain-dysfunction syndrome. MDS 1 Maternal deprivation syndrome, see there 2 Myelodysplastic syndrome, see there Pharma Services Poland Averion International PSI Pharma Support Covance Polska PPD (1) (Parallel Presence Detect) The method used by earlier SIMM memory modules to communicate their capacity to the computer. A binary number coming from a parallel set of pins was read by the system, with each pin representing one bit. Contrast with SPD. 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 Noun 1. tacit consent - (law) tacit approval of someone's wrongdoing secret approval, connivance commendation, approval - a message expressing a favorable opinion; "words of approval seldom passed his lips" " Refusal to issue a licence Procedures relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the work of ethics committees ethics committee A multidisciplinary hospital body composed of a broad spectrum of personnel–eg, physicians, nurses, social workers, priests, and others, which addresses the moral and ethical issues within the hospital. See DNR, Institutional review board. 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 TRIPARTITE. Consisting of three parts, as a deed tripartite, between A of the first part, B of the second part, and C of the third part. contracts Liability in clinical trials Civil liability Product liability Liability in tort tort, in law, the violation of some duty clearly set by law, not by a specific agreement between two parties, as in breach of contract. When such a duty is breached, the injured party has the right to institute suit for compensatory damages. Contractual liability Criminal liability Disciplinary responsibility VAT VAT See: Value-added tax VAT See value-added tax (VAT). on clinical trials Personal data protection in clinical trials Medical documentation Remuneration of researchers EudraCT database Outsourcing (1) Contracting with outside consultants, software houses or service bureaus to perform systems analysis, programming and datacenter operations. Contrast with insourcing. See netsourcing, ASP, SSP and facilities management. of clinical trials Clinical trials with minors National standards European standards Planned amendments to clinical trial regulations Clinical Trials Act Ordinance A law, statute, or regulation enacted by a Municipal Corporation. An ordinance is a law passed by a municipal government. A municipality, such as a city, town, village, or borough, is a political subdivision of a state within which a municipal corporation has been on Template (1) A pre-designed document or data file formatted for common purposes such as a fax, invoice or business letter. If the document contains an automated process, such as a word processing macro or spreadsheet formula, then the programming is already written and embedded in the of Application to Commence a Clinical Trial Application to the Health Ministry Application to Bioethics bioethics, in philosophy, a branch of ethics concerned with issues surrounding health care and the biological sciences. These issues include the morality of abortion, euthanasia, in vitro fertilization, and organ transplants (see transplantation, medical). Committee Changes planned in the "minor amendment" to the Pharmaceutical Law Non-commercial trials Inspections of clinical trials Investigational medicinal product medicinal product, n a substance administered to humans or animals through injection, application, oral ingestion, inhalation, and so forth, whose purpose is to ultimately restore health or eliminate disease in an individual. 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 http://www.researchandmarkets.com/research/55b871/clinical_trials_in. |
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