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Developing a Model to Predict a CRO’s Successful Transition

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Medicilon offers fully integrated pharmaceutical services for the global scientific community. We focus on providing an exceptional client-centered experience and advancing the drug discovery process.

Email: Marketing@medicilon.com.cn               Website: www.medicilon.com

Medicilon is the first CRO company to provide a full set of pre-clinical trial services and our company meet chinese GLP a nd the USA GLP standards at the same time.Our company is the only one China CRO company to build cooperation with the foreign large CRO company.Medicilon provides biology, chemistry and preclinical research,our animal experiment facility has won international assessment of experimental animals and recognition(AAALAC) and chinese food and drug administration GLP certificate,and has reached the United States food and frug administration GLP standard.

Over the past 30 years, the Pharmaceutical Industry (Pharma) has gone through a transformation of mega-mergers and global expansion. The top 20 Pharma companies now account for 70% of the global industry revenue with just the top 10 accounting for half of the market. Strong profits have allowed large Pharma to fund big and broad businesses, which included carrying large fixed costs to support periods of peak demand and avoid development delays. However, the industry has spent the last decade struggling to improve research and development productivity and instead focused on capabilities for which they can truly be best-inclass. One major approach that has become standard within the Pharma industry in the U.S. has been to extract more value from their R&D costs by outsourcing clinical research operations Including managing clinical trials for drugs not yet approved by the FDA — to Clinical/Contract Research Organizations (CROs). Managing these outsourcing relationships with CROs has thus become critical capability for large pharmaceutical companies as it provides options to migrate their CRO relationships from tactical, contract-by-contract outsourcing to more strategic partnerships that can leverage opportunities that combine the resources, processes, and tools of both the Pharma sponsor and the CRO to successfully compete in the marketplace. As of 2009, 88% of large pharma were using less than 10 CROs each year (J.Vogel, 2009). Recently, electronic data capture (EDC) systems have also emerged to replace expensive and time-consuming manual processes for clinical data management. Pharma companies that outsource to a CRO that has adopted this type of eClinical technology can reap the benefits of increased efficiencies and standardization that these technologies offer without having to make their own investments in EDC technologies. CROs that invest in and successfully implement EDC technologies for their Pharma sponsors could also be viewed as having more potential to be a strategic partner for a given sponsor in the future.

This dissertation will focus on developing a model to predict a CRO’s successful transition from a Transactional Outsourcing arrangement to a Preferred-Provider partnership status for clinical research that involves a CRO using EDC. More specifically, the transition will be studied in the context of clinical trial outsourcing projects that are Phase IIb/Phase III oncology EDC projects that have been outsourced from large Pharma companies to a large CRO company.

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