Overview:

Explore Clinical Operations in Brazil, Russia, India and China

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 about BRIC

Weigh the advantages and drawbacks of different countries and examine rankings for 13 clinical 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 in Emerging Markets

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 to Boost Success

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.

BRIC Clinical Development Metrics
Executive Summary

    * Average percentage of budget saved by running a site in BRIC markets
    * Average percentage of time saved by running a site in BRIC markets
    * Population comparisons between BRIC nations, the United States and Europe
    * Number of registered studies across profiled BRIC countries
    * Rankings from surveyed companies of benefits and challenges:
          o Patient access
          o Patient retention
          o Regulatory environment
          o Intellectual property laws/practices
          o Cultural concerns
          o Communication and language
          o Clinical trial technology infrastructure
          o Supply chain management
          o Investigators' available knowledge base
          o Data standards
          o Investigator standards
          o Site management standards
          o Anticipated cost


The four chapters in Emerging Markets Clinical Development Series: Brazil, Russia, India and China (BRIC) use primary and secondary information to provide comprehensive overviews of the clinical development environment in each of the BRIC countries. Each country overview contains these elements:

Section 1: Clinical Development Environment

    * 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

    * 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:
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 key clinical feasibility factors
    * Factors that impact clinical environment

Clinical Environment Assessment

    * Regulatory environment
    * Available knowledge base
    * Intellectual property laws/practice
    * Communication/language
    * Cultural concerns
    * Anticipated cost

Trial Operations Assessment

    * 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 the clinical environment and trial operations factors listed above.