Σχέδιο εταιρικής ανάπτυξης στον τομέα των CROs (Contract Research Organizations)
Company growth plan on Contract Research Organization (CRO) industry

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Keywords
CRO ; Φαρμακοβιομηχανία ; Κλινικές μελέτες ; Business plan ; Clinical trialsAbstract
This dissertation evaluates the potential for a hypothetical Contract Research Organization (CRO) located in Southern Europe, to expand strategically into Italy’s competitive and highly regulated pharmaceutical research market as a mid-size organization. The need for this type of analysis is rooted in the changing role of CROs — from service provider to strategic partner in global R&D — which has created unique challenges and opportunities for both larger and smaller/newer CROs, particularly in regional markets where there are limited resources available to support their development. Therefore, the primary goal of this dissertation will be to develop a viable and sustainable growth strategy for a mid-size CRO, through the use of literature review, market analysis, and financial modeling, with an emphasis on the exploitation of a market niche, operational scale, and compliance with regulatory requirements.
The dissertation will emphasize the importance of developing credibility through scientific expertise, regional partnership, and innovative technology as well as recognize the inherent risks such as bureaucratic complexities, recruitment challenges, and competitive tension associated with developing and growing a business in another country. In addition, it is recommended that a staged approach be taken to develop a business strategy in Italy; specifically, establishing a legal and operational presence prior to gradually increasing the level of service delivery beyond Italian borders. The financial forecasting demonstrates that moderate, responsible growth is achievable over the first three years of operation, from the start-up phase to the operational maturity phase.
Generally speaking, the results demonstrate that successful growth requires much more than numerical data. Successful growth requires alignment with local realities, access to the appropriate people and the establishment of trust. A mid-size CRO can successfully compete in a highly fragmented industry by finding a balance between innovative approaches and the requirements of the local market. The findings of this dissertation provide niche CROs with relevant information regarding the development of responsible growth strategies within complex regulatory environments. The findings of this dissertation provide similar organizations with practical recommendations regarding long-term international growth.


