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Emerging Markets Clinical Development Series: Brazil, Russia, India and China (BRIC)
Cutting Edge Information, Nov 2010, Pages: 275
The next frontier of global industry expansion makes its home in Brazil, Russia, India and China (BRIC). Imagine the impact of a patient pool that numbers 3 billion, an immediate cure for patient shortages (or recruitment challenges) that plague studies in North America and Western Europe, unparalleled access to untapped patient populations, and new opportunities to meet the growing medical needs of these countries.
Despite vast promise as the next major growth opportunity for life sciences companies, the BRIC countries collectively represent a daunting challenge to new product development strategists and clinical operations teams. Any number of unknowns, unfamiliar regulatory guidelines, intellectual property concerns, time and distance barriers, and tolerance of dishonest business practices, can cause companies to hesitate to invest in these emerging markets or keep them out altogether.
Confidently tap into the potential of the BRIC markets, fulfill protocol, and ultimately, realize significant cost and time savings. Expand your understanding of BRIC, individually and as a whole, using rankings data and best practices to map out a winning clinical strategy:
- Eliminate confusion: Weigh the advantages and drawbacks of different countries and examine rankings for 13 cllnical factors to enable strategic decision- making. Gain quick access to relevant demographics and economics information for a comprehensive analysis of the clinical environment.
- Master trial management: Learn from top executives’ firsthand experiences, both successes and misfires. Recommendations show your team how to improve CRO selection, management and oversight, and more. Explore 23 in-depth profiles and find one that matches your company’s situation.
- Clarify misperceptions: Differences in cultural attitudes and behavior impact trial success. Knowledge and awareness go a long way in cultivating strong and beneficial relationships with local CROs.
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 location
- Percentage of time saved by running a trial in this location
- 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 23 company profiles that contain the following components:
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 the company’s estimated average time and cost savings gained from working within the country.
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