The report analyses the environment for conducting clinical trials in
Poland, Hungary, the Czech Republic, Romania, Slovakia and
Bulgaria. It presents key information regarding market size in terms of
the number of clinical trials and size of market share of the largest sponsors.
It also covers the most influential trends and circumstances affecting
the sector and present-day market value, along with forecasts for
2012-2014 based on the number of newly registered clinical trials. It
contains detailed coverage of current and anticipated market conditions,
opportunities and obstacles to overall market growth, length of the average
registration time for clinical trials, attributes and market standing of the
major companies conducting clinical trials, the largest players
(sponsors and CROs, their activity in the area of clinical trials, with
special attention given to the number of trials, location, and therapeutic
areas).
The report also features a comparative analysis of market, governmental and
regulatory conditions governing the conduct of clinical trials in the analysed
CE countries.
Why learn more about this market?
This region is very attractive to pharmaceutical companies and there are many
conferences and a great deal of activity and interest in the subject of
clinical trials. Companies are searching urgently for new areas in which to
establish and conduct trials, as in the developed countries, the recruitment
rate is very slow. Timing is important, since companies are now under
increasing pressure to develop new therapies as patents on many blockbuster
drugs have expired or will expire in the near future.
Key information contained in this report:
Size of the clinical trials market in CE (as determined by number of
trials) with forecasts for 2012-2014 and breakdowns for individual countries.
It includes major trends and circumstances that have affected the development
of the sector in the last couple of years.
The current market situation, opportunities for and obstacles to its
further development
The average registration time for clinical trials
" Comparative analysis of conditions under which clinical trials are conducted
in CE Legal aspects of the sector, including information on the upcoming
legislative modifications that are relevant to the conduct of Clinical Trials
Detailed profiles of the largest CROs and trial sponsors active in the region.
Questions answered by this report:
Which countries are the best and worst choices in which to conduct a
clinical trial?
What are the specific conditions, benefits and drawbacks of conducting
clinical trials in Poland, Hungary, the Czech Republic, Romania, Slovakia and
Bulgaria?
Which are the most active sponsors in the region, what types of drugs are
currently being tested, and which trial phases are being conducted?
Which are the largest and most influential CROs in the region?
What is the average time to register a clinical trial in Central European
countries?
Which countries are noted for delays during the registration of a clinical
trial?
Which legal regulations have the most profound effects on clinical trials?
Unique information provides added value
With unique coverage and analysis of market conditions in each of the covered
countries, careful analysis of relationships between trends and results,
solid, explanatory forecasts and in depth profiles of the market's most
experienced and successful players, this comprehensive report surpasses all
competition in terms of value.
Companies mentioned in this report:
Roche, Pfizer, Novartis, GlaxoSmithKline, Eli Lilly, Bristol-Myers Squibb,
AstraZeneca, Johnson and Johnson, Boehringer Ingelheim, Amgen, Total,
Quintiles, Covance, Icon, Parexel, Premier Research, INC Research, PRA, PPD,
PSI, Monipol.
This report is an essential business resource:
When beginning operations in the CE clinical trials market
When expanding into the clinical trials market in new countries
When effecting a merger or acquisition
When developing a strategy for success in this marketplace
When analysing the potential of this marketplace
When monitoring activity in this market
When estimating the market share of a specific company
When preparing forecasts regarding the number of upcoming clinical trials
When preparing in-house analyses for management and/or shareholders.
This report is targeted to the needs of:
Pharmaceutical manufacturers - sponsors of clinical drug trials
Companies that are in the business of conducting clinical trials - CRO, SMO
Companies engaged in producing innovative pharmaceuticals
Firms specializing in consulting, research and analysis
Government institutions, embassies, universities and research institutes
Chambers of commerce, trade and industry organisations
Barriers to conducting clinical trials in Central Europe are mainly
administrative hurdles often encountered by market players operating in
emerging countries, such as time delays in completing administrative
procedures or difficulties connected with logistics. Cultural differences may
also cause interference and difficulty.
The global economic crisis has adversely affected the number of clinical
trials held in all countries analysed by this report. Regionally, in 2009, the
decline in the number of trials was nearly 5% compared to 2008. In 2010, the
entire CE market recovered, posting a 4% higher level of approved trials than
in 2009. As our estimates showed, 2011 ended with a slightly lower growth
dynamic than 2010, attributed mostly to a decrease in the number of trials in
Hungary due to legal changes.
Market commentary by expert
In the area of clinical trials, the Central European region provides unique
advantages to international pharmaceutical concerns: the associated costs of
trials remain relatively low, it is easier to find appropriate candidates to
participate in a clinical trial, as candidates are more interested in
participation due to lack of money and limited reimbursement. The region
analysed still participates in a centralised healthcare system, which means
that its countries contain large hospitals that specialise in oncology,
cardiology and rheumatology, which rank among the most popular therapeutic
categories for clinical trials. Worthy of note, however, are the drawbacks and
barriers described by the report as they represent crucial knowledge for any
company conducting (or intending to commence) clinical trials in the six
countries analysed in the publication.
Monika Stefańczyk, Head Pharmaceutical market Analyst
Table of Contents
Table of Contents
Methodology
Executive summary
Size of the clinical trial market in CE between 2004 and 2014
Main trends and events in the clinical trials segment
Overview of trends and events in CE
Poland
Hungary
Czech Republic
Romania
Bulgaria
Slovakia
Number of clinical trials conducted in CE
Phases of clinical trial conducted in CE
Categories of drugs under investigation in CE
Share of CE in the clinical trials conducted worldwide
Poland
Number of clinical trials
Phases
Therapeutic categories
Hungary
Number of clinical trials
Phases
Therapeutic categories
Czech Republic
Number of clinical trials
Phases
Therapeutic categories
Romania
Number of clinical trials
Phases
Therapeutic categories
Bulgaria
Number of clinical trials
Phases
Therapeutic categories
Slovakia
Number of clinical trials
Phases
Therapeutic categories
Comparative analysis of clinical research environment in selected CE countries
Legislation
Ethics committees
Registration of clinical trials
Number of clinical sites
Patient recruitment
Quality
CRF quality
Cost of clinical trials
General comparison
Inspections of clinical trials
Poland
Hungary
Czech Republic
Romania
Bulgaria
Slovakia
Analysis of clinical trials conducted by international concerns
Roche
Number of trials conducted
Clinical trial phases
Therapeutic categories
R&D spending
Pfizer
Number of trials conducted
Clinical trial phases
Therapeutic categories
R&D spending
Important events
GlaxoSmithKline
Number of trials conducted
Clinical trial phases
Therapeutic categories
R&D spending
Important events
Novartis
Number of trials conducted
Clinical trial phases
Therapeutic categories
R&D spending
Eli Lilly
Number of trials conducted
Clinical trial phases
Therapeutic categories
R&D spending
Bristol-Myers Squibb
Number of trials conducted
Clinical trial phases
Therapeutic categories
R&D spending
AstraZeneca
Number of trials conducted
Clinical trial phases
Therapeutic categories
R&D spending
Important events
Johnson & Johnson
Number of trials conducted
Clinical trial phases
Therapeutic categories
R&D spending
Boehringer Ingelheim
Number of trials conducted
Clinical trial phases
Therapeutic categories
R&D spending
Important events
Amgen
Number of trials conducted
Clinical trial phases
Therapeutic categories
R&D spending
Profiles of selected CROs operating in the CE market
International CROs
Quintiles
Covance
PPD
Icon
Parexel
INC Research
PRA
ClinTec International
Premier Research
PSI (PSI Pharma Support)
Altiora
GCT Trials
Local CROs
Bulgaria
Pro-Val
Convex
Czech Republic
Axon CRO
East Health Outcomes Research Network
Leading Clinical Research
Phamos Central & Eastern Europe
Hungary
HungaroTrial
BiTrial CRO
Argint International
Trial Masters
Poland
KCR
Monipol
Romania
Cebis International
Rotrial
Standard Medical Product
Slovakia
L&V Research Services
PanoniaTrial
Syncro Clinical Research
Assessment of CE potential as a site for clinical trials
Corruption
Demographic trends
Epidemiological trends and the most frequent causes of death
Circulatory system diseases
Cancer
Trachea, bronchus and lung cancer
Breast cancer
Respiratory system diseases
Digestive system diseases
Diabetes
Blood and blood-forming organs diseases
Mental disorders
Genitourinary system diseases
Medical personnel
Healthcare establishments
Number of hospitals
Number of beds
Legislative environment
Poland
Key legislation and institutions regulating clinical research
Obtainment of clinical trials licence
Applying to commence clinical trials
Charges for filing applications for clinical trial registration
Duration of application processing
Refusal to issue a licence
Applications to the ethics committee
Fees for clinical trial opinions
Insurance in clinical trials
Personal data protection in clinical trials
Clinical trials with minors
Planned legislative changes
Hungary
Key legislation and institutions regulating clinical research
Obtainment of clinical trials licence
Applying to commence clinical trials
Charges for filing applications for clinical trial registration
Duration of application processing
Applications to the ethics committee
Insurance in clinical trials
Clinical trials with minors
Czech Republic
Key legislation and institutions regulating clinical research
Obtainment of clinical trials licence
Applying to commence clinical trials
Charges for filing applications for clinical trial registration
Duration of application processing
Applications to the ethics committee
Fees for opinions of ethics committees
Insurance in clinical trials
Personal data protection in clinical trials
Clinical trials with minors
Romania
Key legislation and institutions regulating clinical research
Obtainment of clinical trials licence
Applying to commence clinical trials
Charges for filing applications for clinical trial registration
Duration of application processing
Applications to the ethics committee
Fees for clinical trial opinions
Refusal to issue a licence
Insurance in clinical trials
Clinical trials with minors
Planned legislative changes
Bulgaria
Key legislation and institutions regulating clinical research
Obtainment of clinical trials licence
Applying to commence clinical trials
Charges for filing applications for clinical trial registration
Duration of application processing
Applications to the ethics committee
Fees for clinical trial opinions
Insurance in clinical trials
Personal data protection in clinical trials
Clinical trials with minors
Slovakia
Key legislation and institutions regulating clinical research
Obtainment of clinical trials licence
Applying to commence clinical trials
Charges for filing applications for clinical trial registration
Duration of application processing
Applications to the ethics committee
Fees for clinical trial opinions
Duration of application processing
Clinical trials with minors
List of graphs
List of tables
About PMR
Contact PMR
List of graphs
Number of clinical trials in CE countries analysed and change (%),
2008-2014
Share of individual countries in total CE region, by number of newly
registered clinical trials, 2011 and 2014
CAGR for countries analysed, by number of newly registered clinical
trials, 2012-2014
Regions where biotech and pharma staff would invest most heavily if they
ran a global CRO (%), H1 and H2 2011
R&D investment value of top 10 EU Scoreboard pharmaceutical companies and
leading EU Scoreboard pharmaceutical companies in CEE (€ m), 2010
CEE Scoreboard pharmaceutical companies by R&D to net sales ratio (%),
2009 and 2010
Top 10 EU Scoreboard pharmaceutical companies and leading CEE Scoreboard
pharmaceutical companies by R&D to net sales ratio (%), 2010
Number of clinical trials in CE countries analysed and change (%),
2008-2014
Breakdown of open clinical trials in CE countries analysed (%), March 2012
Number of open clinical trials in CE, by therapeutic category, as of March
2012
Share of CE countries analysed in global number of clinical trials (%),
2005-2010
Number of new clinical trials registered in Poland and change (%),
1994-2014
Breakdown of open clinical trials in Poland (%), by phase, as of March 2012
Number of open clinical trials in Poland (%), by therapeutic category, as
of March 2012
Number of new clinical trials registered in Hungary and change (%),
2005-2014
Breakdown of open clinical trials in Hungary (%), by phase, as of March
2012
Number of open clinical trials in Hungary (%), by therapeutic category, as
of March 2012
Number of new clinical trials registered in the Czech Republic and change
(%), 2005-2014
Breakdown of open clinical trials in the Czech Republic (%), by phase, as
of March 2012
Number of clinical trials authorised in the Czech Republic (%), by
therapeutic category, 2000-2011
Number of open clinical trials in the Czech Republic (%), by therapeutic
category, as of March 2012
Number of new clinical trials registered in Romania and change (%),
2008-2014
Breakdown of open clinical trials in Romania (%), by phase, as of March
20121
Number of new clinical trials registered in Romania, by phase, 2008 and
2009
Number of open clinical trials in Romania, by therapeutic category, as of
March 2012
Number of new clinical trials registered in Bulgaria and change (%),
2008-2014
Breakdown of open clinical trials in Bulgaria (%), by phase, as of March
2012
Number of open clinical trials in Bulgaria (%), by therapeutic category,
as of March 2012
Number of new clinical trials registered in Slovakia and change (%),
2000-2014
Breakdown of open clinical trials in Slovakia (%), by phase, as of March
2012
Number of open clinical trials in Slovakia (%), by therapeutic category,
as of March 2012
Average time of clinical trials registration in CE region, 2010
Relative cost of conducting clinical research in Poland, the Czech
Republic and Hungary in comparison with selected other countries, 2008
The potential for clinical studies in Poland, the Czech Republic and
Hungary in comparison to selected other countries, 2010
Number of clinical inspections carried out by the FDA in CE countries
analysed, 1988-2011
Results of inspections of clinical trials conducted by FDA in CE countries
analysed, 1988-2011
Deficiencies identified by the FDA during inspections of clinical trials
conducted in CE countries analysed, 1988-2011
Number of clinical investigator inspections carried out in Poland,
1988-2011
Results of inspections of clinical trials conducted by FDA in Poland,
1988-2011
Deficiencies identified during inspections of clinical trials conducted in
Poland by the FDA, 1988-2011
Number of clinical investigator inspections carried out in Hungary,
1988-2011
Results of inspections of clinical trials conducted by FDA in Hungary,
1988-2011
Deficiencies identified during inspections of clinical trials conducted in
Hungary by the FDA, 1988-2011
Number of clinical investigator inspections carried out in the Czech
Republic, 1988-2011
Results of inspections of clinical trials conducted by FDA in the Czech
Republic, 1998-2011
Deficiencies identified during inspections of clinical trials conducted in
the Czech Republic by the FDA, 1988-2011
Number of clinical investigator inspections carried out in Romania,
1988-2011
Results of inspections of clinical trials conducted by FDA in Romania,
1988-2011
Deficiencies identified during inspections of clinical trials conducted in
Romania by the FDA, 1988-2011
Number of clinical investigator inspections carried out in Bulgaria,
1988-2011
Results of inspections of clinical trials conducted by FDA in Bulgaria,
1988-2011
Deficiencies identified during inspections of clinical trials conducted in
Bulgaria by the FDA, 1988-2011
Leading 10 sponsors of clinical trials in the CE countries (number of
trials), as of March 2012
Breakdown of Roche clinical trials in the CE countries analysed, as of
March 2012
Breakdown of Roche clinical trials in the CE countries analysed, by
therapeutic category, as of March 2012
Roche Pharmaceuticals spending on research and development (CHF m), y-o-y
change and its share as a proportion of the company's sales (%), 2004-2011
Breakdown of Pfizer clinical trials in the CE countries analysed, as of
March 2012
Breakdown of Pfizer clinical trials in the CE countries analysed, by
therapeutic category, as of March 2012
Pfizer spending on research and development ($ m), y-o-y change and its
share as a proportion of the company's revenues (%), 2004-2011
Breakdown of GSK clinical trials in the CE countries analysed, as of March
2012
Breakdown of GSK clinical trials in the CE countries analysed, by
therapeutic category, as of March 2012
GlaxoSmithKline spending on research and development (£ m), y-o-y
change and its share as a proportion of the company's revenues (%), 2001-2011
Breakdown of Novartis clinical trials in the CE countries analysed, as of
March 2012
Breakdown of Novartis clinical trials in the CE countries analysed, by
therapeutic category, as of March 2012
Novartis' spending on research and development ($ m), y-o-y change and its
share as a proportion of the company's net sales (%), 2004-2011
Breakdown of Eli Lilly clinical trials in the CE countries analysed, as of
March 2012
Breakdown of Eli Lilly clinical trials in the CE countries analysed, by
therapeutic category, as of March 2012
Eli Lilly spending on research and development ($ m), y-o-y change and its
share as a proportion of the company's revenues (%), 2002-2011
Breakdown of Bristol-Myers Squibb clinical trials in the CE countries
analysed, as of March 2012
Breakdown of Bristol-Myers Squibb clinical trials in the CE countries
analysed, by therapeutic category, as of March 2012
Bristol-Myers Squibb spending on research and development ($ m), y-o-y
change and its share as a proportion of the company's revenues (%), 2002-2011
Breakdown of AstraZeneca clinical trials in the CE countries analysed, as
of March 2012
Breakdown of AstraZeneca clinical trials in the CE countries analysed, by
therapeutic category, as of March 2012
AstraZeneca spending on research and development ($ m), y-o-y change and
its share as a proportion of the company's revenues (%), 2004-2011
Breakdown of Johnson & Johnson clinical trials in the CE countries
analysed, by country, as of March 2012
Breakdown of Johnson & Johnson clinical trials in the CE countries
analysed, by categories, as of March 2012
Johnson & Johnson spending on research and development ($ m), y-o-y change
and its share as a proportion of the company's sales (%), 2002-2011
Breakdown of Boehringer Ingelheim clinical trials in the CE countries
analysed, as of March 2012
Breakdown of Boehringer Ingelheim clinical trials in the CE countries
analysed, by therapeutic category, March 2012
Boehringer Ingelheim spending on research and development (€ m),
y-o-y change and its share as a proportion of the company's sales (%),
2002-2010
Breakdown of Amgen clinical trials in the CE countries analysed, as of
March 2012
Breakdown of Amgen clinical trials in the CE countries analysed, by
therapeutic category, as of March 2012
Amgen spending on research and development ($ m), y-o-y change and its
share as a proportion of the company's sales (%), 2002-2010
Covance net revenue ($ m) and change (%), 2006-2011
Icon gross revenue ($ m) and change (%), 2006-H1 2011
Parexel service revenues by segment ($ m), 2008-2011
Breakdown of Altiora clinical trials (%), by phase, 2001-2010
Breakdown of Altiora clinical trials (%), by therapeutic category,
2001-2010
Breakdown of ProVal clinical trials (%), by therapeutic category, 1991-2012
BiTrial revenue and net profit (€ m), 2009-2010
Argint International revenues and net profit (€ m) in Hungary, 2010
Trial Masters' revenues and net profit (€ m), 2009-2010
Corruption Perception Index in the CE countries analysed, 2001-2011
List of tables
Examples of partnerships established between top pharmaceutical concerns
and CROs, 2010-2012
Estimated structure of clinical trials value in CEE/CIS regions (%), 2010
CEE pharmaceutical companies in EU Industrial R&D Investment Scoreboard,
by rank and value of R&D investments (€ m), 2005-2010
Clinical portfolio of Gedeon Richter, 2010
Number of clinical trials conducted in CE countries analysed, 2012
Key legal acts regulating the conduct of clinical trials in CE countries
analysed, 2012
Rules of conduct for ethics committees in CE countries analysed, 2012
Registration of clinical trials in selected CEE countries, 2012
Number of clinical trial sites in Poland, the Czech Republic and Hungary
in comparison with selected other countries, 2008
Patient recruitment per site in a non-metastatic renal carcinoma study in
Poland and the Czech Republic in comparison with selected other countries, 2009
Patient recruitment per site in acute heart failure and renal impairment
with volume overload study in Poland and Romania in comparison with selected
other countries, 2009
CRF quality per site in a renal carcinoma study in Poland and the Czech
Republic in comparison with selected other countries
CRF quality per site in a heart failure study in Poland, the Czech
Republic, Hungary and Romania in comparison with selected other countries
Conducting clinical trials in Bulgaria and Romania in comparison with
Russia and Ukraine, 2009
Breakdown of Roche clinical trials in the CE countries analysed, by phase,
as of March 2012
Selected Roche clinical trials carried out in CE countries, as of March
2012
Breakdown of Pfizer clinical trials in the CE countries analysed, by
phase, as of March 2012
Selected Pfizer clinical trials carried out in CE countries, as of March
2012
Breakdown of GSK clinical trials in the CE countries analysed, by phase,
as of March 2012
Selected GlaxoSmithKline clinical trials carried out in CE countries, as
of March 2012
Breakdown of Novartis clinical trials in the CE countries analysed, by
phase, as of March 2012
Selected Novartis clinical trials carried out in CE countries, as of March
2012
Breakdown of Eli Lilly clinical trials in the CE countries analysed, by
phase, as of March 2012
Selected Eli Lilly clinical trials carried out in CE countries, as of
March 2012
Breakdown of Bristol-Myers Squibb clinical trials in the CE countries
analysed, by phase, as of March 2012
Selected Bristol-Myers Squibb clinical trials carried out in CE countries,
as of March 2012
Breakdown of AstraZeneca clinical trials in the CE countries analysed, by
phase, as of March 2012
Selected AstraZeneca clinical trials carried out in CE countries, as of
March 2012
Breakdown of Johnson & Johnson clinical trials in the CE countries
analysed, by phase, as of March 2012
Selected Johnson & Johnson clinical trials carried out in CE countries, as
of March 2012
Breakdown of Boehringer Ingelheim clinical trials in the CE countries
analysed, by phase, as of March 2012
Selected Boehringer Ingelheim clinical trials carried out in CE countries,
as of March 2012
Breakdown of Amgen clinical trials in the CE countries analysed, by phase,
as of March 2012
Selected Amgen clinical trials carried out in CE countries, as of March
2012
Selected largest CROs operating in the clinical trials market in CE
countries analysed, 2012
Quintiles revenues and net profit (€ m) in selected CE countries
analysed, 2009-2010 or H1 2011
Covance revenue and net profit (€ m) in selected CE countries
analysed, 2009-2010
Information on PPD presence in selected CE countries analysed, 2012
PPD revenue and net profit (€ m) in selected CE countries analysed,
2009-2010 or H1 2011
Icon revenues and net profit (€ m) in selected CE countries
analysed, 2009-2010
Parexel revenue and net profit (€ m) in selected CE countries
analysed, 2009-2010 or H1 2011
Premier Research revenue and net profit (€ m) in selected CE
countries analysed, 2009-2010 or H1 2011
PSI revenue and net profit (€ m) in selected CE countries analysed,
2009-2010 or H1 2011
Sample of recent trials conducted by GCT, 2012
Statistical figures of BiTrial CRO activity, 2012
Population of the CE countries analysed ('000 people), 2006-2011
Percentage of population aged 0-14 years in the CE countries analysed,
2006-2010
Percentage of population aged 65 or over in the CE countries analysed,
2006-2010
Forecast of population in CE countries analysed ('000 people), 2015-2035
Crude death rate in the CE countries analysed, 2006-2010
Number of diseases of circulatory system in CE countries analysed,
2006-2010
Number of ischaemic heart diseases in CE countries analysed, 2006-2010
Number of cerebrovascular diseases in CE countries analysed, 2006-2010
Number of cancer cases in CE countries analysed, 2006-2010
Number of deaths caused by cancer in CE countries analysed, 2006-2010
Number of trachea, bronchus and lung cancer in CE countries analysed,
2006-2010
Number of deaths caused by trachea, bronchus and lung cancer in CE
countries analysed, 2006-2010
Percentage of smokers in CE countries analysed (%), 2012
Number of female breast cancer in CE countries analysed, 2006-2010
Number of deaths caused by malignant neoplasm female breast cancer in CE
countries analysed, 2006-2010
Number of deaths caused by the respiratory system diseases in selected CE
countries analysed, 2006-2010
Number of deaths caused by the bronchitis/emphysema/asthma in CE countries
analysed, 2006-2010
Number of deaths caused by the digestive system diseases in CE countries
analysed, 2006-2010
Diabetes prevalence in selected CE countries analysed (%), 2006-2010
Number of deaths caused by diabetes in CE countries analysed, 2006-2010
Number of deaths caused by blood and blood-forming organs diseases in CE
countries analysed, 2006-2010
Mental disorders in selected CE countries analysed (%), 2006-2010
Number of deaths caused by mental disorder/diseases of nervous
system/sense organs in CE countries analysed, 2006-2010
Number of deaths caused by genitourinary system diseases in CE countries
analysed, 2006-2010
Number of practising physicians in the CE countries analysed, 2001-2009
Number of hospitals in CE countries analysed, 2006-2009
Number of acute (short-stay) hospitals in CE countries analysed, 2006-2009
Number of hospital beds in CE countries analysed, 2006-2009 or 2010
Number of acute care hospital beds in CE countries analysed, 2006-2009 or
2010
Documentation required for approval of a clinical trial on a human
pharmaceutical in Poland, 2012
Documents provided with the application for a Bioethics Committee opinion
on a clinical trial, 2012
Minimum guaranteed sum of civil liability cover for researchers and
sponsors of clinical trials in Poland, 2010
List of legal acts regulating clinical trials in Hungary, 2012
Documentation required for approval of a clinical trial on a human
pharmaceutical in Hungary, 2012
Types of application procedure for clinical trials in Czech Republic, 2012
Documentation required for the approval/notification of a clinical trial
on a human pharmaceutical in Czech Republic, 2012
Fees for filing applications and other fees connected with clinical trials
in Czech Republic, 2012
Documentation required for ethics committees (multi-centre and local) in
Czech Republic, 2012
List of the most important legal acts regulating clinical trials
implemented in Romania, 2012
Documentation required for approval of a clinical trial on a human
pharmaceutical in Romania, 2012
Charges for filing applications for clinical trial registration in
Romania, 2012
Documentation required for approval of a clinical trial on a human
pharmaceutical in Bulgaria, 2012
Fees for clinical trials in Bulgaria, 2012
Changes in clinical trials procedures included in Act No. 362/2011 on
medicines and medical devices and amendments to related acts in Slovakia, 2012
Documentation required for approval of a clinical trial on a human
pharmaceutical in Slovakia, 2012
Duration of approval of clinical trials applications in Slovakia, 2010
Clinical trials in Central Europe 2012: Development forecasts for 2012-2014 published by PMR in April 30, 2012. This report consists of 193 Pages and the price starts from US $ 3500.
