subject: Pharma-cro Relations: The Key To Clinical Development [print this page] Clinical Research is a highly people-centric business where interpersonal and team relationships are key determinants of success. The relation between a pharmaceutical company and a Contract Research Organization (CRO) is like any other business or personal relationship and needs to be managed well.
The success of Pharmaceutical companies, who do not have in-house clinical research capabilities, depends heavily on CROs that provide these services. Likewise, the success of these service providers depends on their ability to build and manage relationships with the sponsors they support. This, however, is a tough task given that Pharmaceutical companies treat outsourcing as a transaction rather than a partnership. Hence, Pharma-CRO relationships have a long way to go before they could be characterized as strategic1.
Jayesh Chaudhary, CEO, ClinACE feels that Pharma-CRO relationships depend not only on the skills, knowledge or qualifications but also on the attitudes of the people at both ends as well. Attitudes of CRO key staff and management, their work culture and core values play a key role in determining which organization the pharma company will finally outsource the research to. These aspects are kept in mind during their selection of a CRO. Is there a cultural fit? is a question that outsourcing managers may ask themselves sub-consciously as part of their CRO selection procedures.
Let us review some of the common constraints that sponsors have cited for relations with CROs not maturing and their possible causes.
Sponsors feel that CROs are not proactively innovative. Innovation happens best when there is a sense of belonging in the product being created. The good sense of ownership for the project must be instilled in the project staff from the very beginning. Lack of an ownership attitude could clearly have a negative impact on project performance in aspects ranging from strategic to tactical planning, decision-making and execution. While innovation skills can be taught, most managers are naturally creative and will invent new ways to solve project issues provided they connect with the project and have the necessary freedom to operate.
CROs claim: Sponsors are unwilling to relinquish control and engage in micromanaging us. Clearly there is an element of skill and experience involved in controlling outsourced projects, but an attitudinal change will also help. Sponsors can motivate CROs by sharing the larger picture with them, instilling a sense of purpose and pride. Having done this much, they need to trust the CRO. The project managers need to be on the same page of course regarding the key performance indicators, risk variables and contingency plans. On their part, the CRO has to win the trust of the Sponsor by meeting targets early in the life of the project. However, if the CRO fails to do so then the Pharma Company has no choice but to micromanage and the whole outsourcing model collapses. This might be the reason that pharma companies prefer not to use the term preferred provider and use qualified provider instead.
Lastly, the cornerstone for any successful relationship is an unselfish attitude. Although Pharma companies and CROs are both in it for profits, a relationship cannot be built and expected to flourish merely on this ground. Sponsors would do well to ask themselves constantly how the CRO partner can benefit other than the timely payment of fees. CROs can consider going the extra mile if the project demands it and can demonstrate an attitude of enthusiasm in offering value-added services and hope that at least some companies would eventually appreciate it and pave the way to a strategic partnership rather than a transactional one.
There are several other reasons why outsourced research is increasingly flowing to the East, but a factor that has not been discussed much is the social structure in many South and Southeast Asian cultures, which is conducive to nurturing strategic partnerships. Hence, such attitudes thrive in Indian CROs who offer the right cultural fit for Pharmaceutical sponsors wishing to outsource drug development. This could be one of the reasons why India is an emerging destination for outsourcing clinical research.
