A model of key indicators to predict a successful CRO transition

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.

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In recent years, CRO companies have developed the capacity and expertise to take on an even larger portion of drug development and commercialization processes. This enables Pharma sponsor companies to reduce or better manage costs, improve productivity, and maintain their focus on core capabilities.

As will be discussed, clinical trials have become more complex for new drugs, and the task of selecting a suitable CRO for a particular project still remains a difficult choice for many pharmaceutical companies. The potential benefits for outsourcing to a CRO are also often difficult to demonstrate when a CRO is working on contracts for short, one-study-at-atime projects, as occurs within Transactional outsourcing arrangements. With Preferred-Provider partnerships, CROs can increase their efficiencies across the life cycle of a clinical trial and provide a more reliable delivery schedule to their Pharma customer. What is needed, therefore, is for both parties to build an effective working relationship that enables a successful transition to Preferred-Provider status. The challenge for many CROs is not only to execute an effective implementation that will reach a successful outcome for projects under a Transactional contract, but to do so consistently across a large volume of projects.

Given this growing role of CROs in Pharma R&D, there is a need to increase our understanding about what factors related to eClinical technology, processes to govern the relationship, and the utilization of resources enable a CRO to transition from a tactical to a more strategic partnership relationship. Yet to date, limited management research has been undertaken to directly address this issue. Under the assumption that all new outsourcing relationships between a CRO and a Pharma sponsor begin with a Transactional outsourcing arrangement, the overall research question for this study is: What key indicators predict successful CRO transitions from Transactional Outsourcing status to Preferred-Provider Partnership status within pharmaceutical eClinical trial outsourcing?

To answer this research question, a predictive model that includes three Change Management factors is developed based on both the researcher’s decade-long industry observations and previously published literature. Secondary data that includes project-level and partnership-level outcomes for a set of EDC outsourcing engagements between a single large CRO and three large Pharma companies is then used to validate the model. The findings are then discussed for the Change Management factors, including the probabilities for project success under Transactional contracts and different configurations of the Change Management factors, and implications for future research are drawn. The model findings are expected to not only advance knowledge on this evolving outsourcing topic for future research, but also to provide significant value to practitioners within the industry.

More specifically, the objective is to provide a model that can be used as a tool for large CRO companies to identify how best to align their eClinical technology investments, structure their governance processes, and execute their operational resources with the goal of reaching a Preferred-Provider partnership status with pharmaceutical sponsors. In addition, Pharma PREVIEW 4 companies can leverage this tool to understand the types of outsourcing partnerships they are seeking with CROs. This knowledge may also help these organizations increase revenue and share price for shareholders/investors.