Sponsor-CRO relationship

This approach uses a mix of in-house and outside resources. It is closest to the modem view outlined earlier. The sponsor conducts phase I and early phase II studies, and hires CROs to conduct larger and routine studies (e.g. late phase II and phase III). An important corollary of strategic outsourcing is that CROs are prequalified according to projected sponsor needs. Relationships are developed between the sponsor and certain CROs that can perform particular types of studies. 

Another important fimchon of the CRC is to interact with the sponsor or CRO-appointed CRA. Because the CRA is an agent for the sponsor, the CRC-CRA relationship is one that can make or break a study. If a CRC is doing an excellent job, and the documents are available and accurate, the CRA s interachons with the site should be posihve and productive. Unfortunately, this does not always happen. There are dynamics on both sides of the CRF. Some conunon complaints are ... 

When properly managed, CRO services can provide a cost-effective solution and thereby enhance the ability of the sponsor team to achieve the corporate goals that are typically defined by time and budget constraints. However, if the relationship is mismanaged, valuable time and money will be wasted. A common reason for failure is ineffective communication. Effective communication between the sponsor and CRO must occur at all stages of the relationship, including ... 

The start-up of the relationship requires a considerable amount of time from sponsor personnel to ensure that the scope of the work is fully understood and that standards are clear. This highly interactive phase of the relationship may be ill-timed, unfortunately, because most companies decide to use CROs only after all possibilities of using internal resources have been exhausted, which often means that the sponsor personnel themselves are exhausted too The sponsor staff may have a tremendous desire to hand off the project completely and as quickly as possible to the CRO, but this will not be in the best interest of the project. 

An agreement on the overall budget for the project, although clearly an important milestone, does not actually form the whole of basis of the contractual relationship between the sponsor and the CRO. The two parties must also agree on the type of contract that best meets the needs of both parties. 

Identification and communication of problems requires that the two parties agree on what constitutes a tme problem. Often a sponsor identifies what it believes tobe a significant variance, yetthe CRO fails to respond because experience tells it that the variance will not have an impact on the end result. The result of this miscommunication is that the sponsor loses trust in the CRO, and the relationship is harmed. 

After completion of the study, when the study report is being drafted by the sponsor, the CRO, or a scientific writer. Each of these phases of the relationship will be discussed in turn, with an emphasis on ways to achieve effective communication and a successful relationship. 

As mentioned above, it is possible to use CROs to carry out all, or virtually all, the functions of a sponsor in the conduct of a clinical trial X-CROs are no longer being used in emergency—a last resort. CROs are widely regarded as a primary resource by many companies, so much so that preferred provider and strategic alliance relationships have been developed by many of the major multinational companies. 

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