ZAK Services Clinical Research

by Peter Palagyi, PharmDr. • 17. 09. 2018

Opportunities for Small/Medium Enterprises

Over the past decade, the rising costs of R&D combined with profit pressures, increased regulatory requirements, need for innovation in R&D process, resulted in changing of outsourcing strategy of all big pharmaceutical companies to strategic partnerships. The majority of companies indicated a preference to engage global CROs for exclusive partnerships rather than mid-sized or niche CROs.

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Continuous trend of mergers, acquisitions, and alliances allow the top global CROs being competitive and maintain a unique position in the CRO market. According to the KPMG report, the top 10 CROs represent more than half the market, with the remainder divided among the approx. 1000 small to mid-sized CROs operating around the world.

The above mentioned facts were confirmed also via a survey performed locally by ZAK, aimed to identify and confirm the company requirements in the process of CRO selection.
The results are confirming that biopharmaceutical companies prefer to outsource to full service CROs. Despite this trend, there is still an opportunity for partnership with small or mid-sized CRO that will afford them the client service and focus to maintain long-term relationship. In most of the cases this model works mainly with a focus on therapeutic expertise, becoming a niche provider in order to attract the business of small or mid size pharma companies.
In present, biostatistical analysis is playing a key role in clinical monitoring process, risk based approach with a focus to data trends and identifying of triggers to field monitoring. CRAs require less travel and the Sponsors target and optimize the resources and investments.
In addition, in a small CRO there is a must to offer innovations and broaden the activities with “nontraditional” services which help to attract the business opportunities as well.

As a small privately owned company we are continuously working on strengthening our position in clinical research and maintaining long term relationships with our partners. In this challenging period the company is building on its history, trust and focus to quality which shall also ensure effectiveness and good quality in execution of clinical trials.

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Author

Peter Palagyi, PharmDr.

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