Project Management Opportunities and Challenges in Central and Eastern Europe

The number of research projects in Central and Eastern Europe is increasing rapidly but experience with this region remains limited in the global headquarters of many pharmaceutical companies. The outsourcing of project management activities in Central and Eastern Europe, however, must be considered in light of the opportunities and challenges associated with each project management parameter: Quality: The quality of clinical research in Central and Eastern European countries is generally at least as high as the quality in West-em Europe or the United States. Nevertheless, there are potential challenges in maintaining quality as a result of language and cultural diversity, differences in patient populations between regions, and limited clinical trial experience in some centers. Local expertise is essential for the selection and support of study investigators. However, only the sponsor can determine the appropriateness for a particular study of the available patient population and the usual medical practice in any country. Likewise, only the sponsor can provide the resources to ensure that other potential pitfalls are avoided, for example, through detailed investigator training. Time: Shorter project timeframes, due to rapid patient recruitment into clinical trials, are often the primary reason for conducting studies in Central and Eastern European countries. Taking maximum advantage of this opportunity generally requires the use of local knowledge to avoid unnecessary delays in trial initiation or conduct. The project manager must ensure, however, that the sponsor's own time priorities remain paramount. Cost: Lastly, the Central and Eastern European countries offer an opportunity for cost-effective clinical research because of lower investigator grants than in the West. However, central planning is still necessary to manage total study costs and to manage individual trial budgets within the total program framework. Conclusion: Although local expertise is invaluable in conducting clinical research in Central and Eastern European countries, project management must remain a core competence within the sponsor company in order to maximize the benefits and overcome the challenges of research in this region.