|
|
 |
|
Viewing report
|
|
|
|
Emerging Markets Clinical Development Series: Asia
Cutting Edge Information, Nov 2010, Pages: 193
Asia offers clinical development teams unique benefits for running trials. Among emerging markets, Asian countries offer the highest number of available patients. The region also hosts a thriving pharmaceutical and biotechnology industry, and medical education among investigators has come in-line with Western expectations for Good Clinical Practice. Asia presents an interesting mix of Western knowledge and Eastern practice that has resulted in significant scientific and medical advances. As more companies move clinical trials into this region, they will benefit for years to come from the expertise inherent in Asian markets.
This study is an ideal resource designed to address the challenges and answer your most burning questions about conducting clinical trials in Asia. It provides detailed data on China and India as well as profiles of companies that are conducting trials in Malaysia, Hong Kong, Taiwan, Thailand, Singapore, South Korea and the Philippines. Learn the advantages and challenges that each of these countries presents. Use the benchmarks, metrics and best practices to avoid common pitfalls and solidify your clinical strategy:
- Intellectual property concerns: Asia has a reputation for poor intellectual property protections. But this report uncovers the progress made in China, India and other Asian nations around IP protection. The report will also help you navigate regulations, healthcare infrastructure, costs and patient access.
- Physician-patient relationships: Learn about the strong physician-patient relationships created in different Asian. Tap into these bonds to boost enrollment and retention in your clinical studies.
- Individual country benefits: Too often, companies approach specific emerging markets with regional strategies. This report illustrates the benefits that each individual country provides so that you can develop detailed plans for running trials in each market. Tap into the best ratios of cost, quality and timelines while using local partners to navigate culture, communication and regulations.
The three chapters in Emerging Markets Clinical Development Series: Asia (China, India, Other Emerging Asian Countries) use primary and secondary information to provide comprehensive overviews of the clinical development environment in each of the profiled nations. Data encompass key demographics, economic figures, rankings of clinical development factors and recommendations from clinical veterans.
The report includes critical benchmarks to guide your decision making, including:
- Population comparisons between Asian nations, the United States and Europe
- Number of registered studies across profiled Asian countries
- Rankings from participating companies of benefits and challenges:
-- Patient access
-- Patient retention
-- Regulatory environment
-- Intellectual property laws/practices
-- Cultural concerns
-- Communication and language
-- Clinical trial technology infrastructure
-- Supply chain management
-- Investigators’ available knowledge base
-- Data standards
-- Investigator standards
-- Site management standards
-- Anticipated cost
- Average percentage of budget saved by running a site in Asia
- Average percentage of time saved by running a site in Asia
Each country profile contains these elements:
Section 1: Clinical Development Overview
Charts and analysis focus on these topics:
- Key demographics (population/ethnic breakdowns, life expectancy statistics)
- Key economic figures (GDP, labor force, distribution of family income)
- Disease prevalence
- Politics
- Healthcare system
- Pharmaceutical market (overall picture of market, leading local companies)
Section 2: Clinical Development Strategy
Charts focus on these points:
- Percentage of budget saved by running a trial in this market
- Percentage of time saved by running a trial in this market
- Assigning clinical development responsibilities
Clinical Trial Environment Scores and Trial Operations Scores
Company rankings and CEI analysis of the following factors:
Environment
- Available knowledge base
- Regulatory environment
- Intellectual property laws and practices
- Communication/Language
- Culture
- Anticipated cost
Operations
- Access to patients
- Patient retention rates
- Investigator standards
- Data standards
- Site management standards
- Trial technology infrastructure
- Supply chain management
Section 3: Individual Company Profiles
This report contains a total of 20 company profiles, covering clinical trials in China, India, Hong Kong, Malaysia, Philippines, Singapore, South Korea, Taiwan and Thailand.
Each profile contains these elements: Company Background
- Company mindset and feasibility factors
- Factors that impact clinical environment
Companies rank the following factors impacting clinical environment and trial operations from 1 to 10, with 10 being ideal:
Clinical Environment
- Regulatory environment
- Available knowledge base
- Intellectual property laws/practice
- Communication/language
- Cultural concerns
- Anticipated cost
Trial Operations
- Access to patients
- Patient retention rate
- Investigator standards
- Site management standards
- Data standards
- Trial technology infrastructure
- Supply chain management
Experience in Region
- Activity in Region: maps the geographic scope of the company’s clinical operations within the region.
- Experience Specific to Country: provides information on the company’s operations within the country, including year of entry, method of entry and current level of presence within the country.
Clinical Strategy in Country
- Responsibility Breakdown: shows each company’s clinical operations assignments among four groups, corporate team outside country, corporate team inside country, multinational CRO, and local CRO/vendor. The data detail 12 clinical responsibilities:
- Protocol development
- Site selection
- Investigator training
- Patient recruitment
- Site monitoring
- Investigator management
- Data collection
- Data management
- Data cleaning/analysis
- Medical writing
- Regulatory agency communication
- Health economics consideration
Clinical Environment and Trial Operations Scores: shows a company’s score for each of clinical environment and trial operations factors. Each criterion is rated on a scale of 1 to 10, with 10 representing ideal conditions.
Conclusion: shows each company’s estimated average time and cost savings gained from working within the country.
Product samples
A sample for this product is available. Please Login/Register to download this sample.
|
|
|
|
