Overview:

Expand Clinical Capabilities Throughout Central and Eastern Europe

The countries in Central and Eastern Europe provide ample opportunity for life sciences companies, especially in terms of clinical development. The number of treatment-naive patients in the region makes it an ideal location to host clinical studies. In fact, the population of Central and Eastern European countries exceeds that of either the United States or the five largest Western European markets combined. Furthermore, there is a lower saturation of competing trials within the region compared to other, more developed markets.

Besides a large patient population, Central and Eastern Europe offer the drug and device industries a convenient location — especially for European-based countries — to conduct clinical studies. The region has a long history of clinical development, making it easier to find and train skilled investigators.

Use this study as a resource to design and prepare your company's clinical trials in Central and Eastern Europe. The report addresses, in detail, the challenges and clinical development opportunities that these emerging markets provide. It provides detailed benchmark metrics for Russia, Poland, the Balkans, Bulgaria, Romania, Turkey and Ukraine, all in one place. Learn the advantages and challenges that each of these countries present. Use these data and best practices to avoid common pitfalls and solidify your clinical strategy:

Improve Patient Access

Russia and Poland offer a distinct advantage as emerging markets: access to treatment-naive patients. Recruitment and retention are strong in these countries as well. This report will guide your decision-making process as you determine how to run a trial in a Central or Eastern European nation.

Protect Intellectual Property

IP issues can be daunting when working in an emerging market. This study shows you how to work with local partners to navigate culture and regulations, avoid the threat of corruption and protect your intellectual property.

Tap Geographic and Cultural Proximity

Russia, Poland and the other countries profiled in this report offer the advantage of being neighbors to Western Europe. This means that the local investigator knowledge base is similar to that of Western European countries, and EU-EC guidelines for GCP are becoming more commonplace. Learn about the other advantages that the central and eastern European countries offer to clinical development teams.

European Emerging Markets Metrics

Executive Summary

    * Average percentage of budget saved by running a site in Central and Eastern Europe
    * Average percentage of time saved by running a site in Central and Eastern Europe
    * Population comparisons between Central and Eastern European nations, the United States and Europe
    * Number of registered studies across profiled Central and Eastern European 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 three chapters in Emerging Markets Clinical Development Series: Central and Eastern Europe use primary and secondary information to provide comprehensive overviews of the clinical development environment in Europe'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 18 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 managemen

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.