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Follow on Google News | Report Reserve Announces Emerging Market for Clinical Trials in Brazil-Improved Guidelines from ANVThis provides key data, information and analysis of the major trends and issues affecting the clinical trial market in Brazil.
By: Report Reserve This provides key data, information and analysis of the major trends and issues affecting the clinical trial market in Brazil. The report provides comprehensive insight on the reasons for outsourcing clinical trials to Brazil and the key services provided by the Clinical Research Organizations (CROs) of Brazil. The report provides a detailed analysis of the Brazilian market in terms of its size, and the major service offerings of the CROs in Brazil. The report also discusses the factors that are driving the clinical trial market in Brazil. The report delves into the key documents required by the investigator and the sponsor before, during and after the conduct of clinical trials. The report also provides key alliances between the CROs of other countries and the local CROs of Brazil. The report also looks into the major challenges that can restrict the growth of the clinical trials market in Brazil. This report is built using data and information sourced from proprietary databases, primary and secondary research and in house analysis by GBI Research’s team of industry experts. Rising Financial and Regulatory Pressures on Western Pharmaceutical Companies Will Continue to Drive the Clinical Trial Market Growth in Brazil The pharmaceutical industries of the US and Europe have been facing severe financial constraints over the past few years, which are expected to worsen in the coming years. With constraints such as the increasing cost of introducing New Molecular Entities (NME), which is expected to reach more than $3 billion in 2008, tightening regulatory pressures resulting in fewer FDA and other regulatory agency approvals, blockbuster drugs worth more than $100 billion experiencing patent expiry by 2014, and the drying developmental pipelines of the pharmaceutical industry, cost cutting pressures are mounting on pharmaceutical companies, especially the big ones. These pressures are expected to drive these companies towards low-cost countries such as Brazil for their R&D activities, which are one of their major expenses. Brazil, over the last decade, has developed significant capabilities in clinical trials. Brazil is able to provide significant cost savings in the range of 20-30% for clinical trials. With discovery research occupying close to one-third of the Research and Development (R&D) expenditure for the Western pharmaceutical industry, outsourcing to low-cost countries is logical. As the financial and regulatory pressures grow on the US and European pharmaceutical industry, it is expected to further propel the growth in the clinical trial market in Brazil. Brazil is an Attractive Market for Contract Research Organizations due to Rapid Patient Enrollment and Retention Patient recruitment causes clinical trials to delay in Western countries as people have access to good medical care from government hospitals and also they have medical insurance by which they can afford treatment even in private hospitals. But in Brazil many people are devoid of medical care as there are limited facilities concentrated to a few cities/provinces making these patients can easily available for conducting clinical trials and also it’s easier to find patients who are currently not on any therapy. Brazil has the large treatment naïve population concentrated in urban area, compared to the US, the UK, Western Europe and other countries of Latin America. Patients in Brazil are rational and they rate country’s scientific progress on par with personal health benefits and monetary reimbursements. These factors result in a high participation rate in clinical trials. Therefore the urban population in Brazil and their close proximity to the principal regulatory body National Health Surveillance Agency (ANVISA) and other major health care institutions; The Availability of Qualified and Experienced Talent Pool Presents a Big Advantage One of the most important factors for the successful conduction of clinical trials is the qualified and experienced principal investigators and clinical research team. Brazil has recorded the highest growth rate in the number of FDA regulated principal investigators from 2001 to 2010, compared to the US, the UK and other Latin American countries. Emphasis on early Good Clinical Practice (GCP) training for health professionals has been resulted the significant number of US-trained investigators compliant with International Conference on Harmonization (ICH)-GCP regulations over the years. Therefore these factors have contributed effectively to this growth in the number of principal investigators. Clinical Trial Market in Brazil will Experience a Steady Growth from 2010 to 2015 In 2010 the Brazil clinical trial market was worth $320m, and GBI Research predicts the market will grow at 10.5% to reach $526.4m by 2015. Speed of patient recruitment is one of the main reasons for outsourcing clinical trials to Brazil. The large, ethnically-diverse treatment-naï To get more insights to the topic, please visit http://www.reportreserve.com/ # # # ReportReserve is an online research report distribution company. The company lists several market research reports published by several research houses across the globe. End
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