Overview:

Improve Trial Outcomes with Latin American Operations

As R&D costs rise exponentially and trial subjects grow scarce in the US and Europe, life sciences firms are turning to the emerging markets to supplement patient enrollment — and to reduce costs.

Latin America holds about 1/10 of the number of trials of the United States, and Brazil, numbered among the high-profile BRIC market, receives the lion's share of attention. But savvy companies leverage other nations' untapped promise: patient availability, advanced knowledge and infrastructure, and ease of communication. These advantages are cultivated in an environment open to clinical development, but scores of questions can create reams of data - and misperceptions - and potentially keep teams away.

Eliminate information clutter and zero in on the key emerging markets in Latin America. Access primers on individual countries that include time- and cost savings benchmarks and rankings data while learning from others' first-hand experiences to reap the benefits of the region:
Pick the Right Market

Compare costs, timelines, regulatory environments and problem areas across countries as you discover unique benefits to each. Explore ratings for 13 elements of trial success.
Accelerate Patient Recruitment and Retention

Target markets for treatment-naive patients, and discover the factors to ensure easy recruitment and strong retention.

Navigate Tricky Issues

How do companies protect IP? How do they manage longer setup times and overcome regulatory hurdles? Discover which governments protect IP and find real-company best practices for managing different regulatory guidelines.

Master Trial Management

Balance reliance on local expertise with trial oversight to build strong partnerships. Uncover fresh strategies to prepare your teams for the challenges that will inevitably flare up.

Latin America Emerging Markets Metrics

Executive Summary

    * Average percentage of budget saved by running a site in Latin America
    * Average percentage of time saved by running a site in Latin America
    * Population comparisons between Latin American nations, the United States and Europe
    * Number of registered studies across profiled Latin American 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: Latin America use primary and secondary information to provide comprehensive overviews of the clinical development environment in Latin America's emerging markets:

Section 1: Clinical Development Overview

    * 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 Environment

    * 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 12 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.